1. OCALA, Fla., Sept. 21, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced positive progress with the company's meeting request to the U.S. Food and Drug Administration (FDA) concerning a Phase 2 clinical study of Ampligen as an infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD). The meeting request has been deemed sufficient for transfer to the FDA's Division of Neurology by the FDA's Covid Scientific Technical Triage Team.

    "We are pleased with this next step — the referral to the FDA's Division of Neurology — as our focus is on the brain-related symptoms of Long COVID," said AIM CEO Thomas K. Equels.

    The planned Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study is designed…

    OCALA, Fla., Sept. 21, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced positive progress with the company's meeting request to the U.S. Food and Drug Administration (FDA) concerning a Phase 2 clinical study of Ampligen as an infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD). The meeting request has been deemed sufficient for transfer to the FDA's Division of Neurology by the FDA's Covid Scientific Technical Triage Team.

    "We are pleased with this next step — the referral to the FDA's Division of Neurology — as our focus is on the brain-related symptoms of Long COVID," said AIM CEO Thomas K. Equels.

    The planned Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study is designed to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD. Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks. Amarex Clinical Research, an NSF International company, will manage the clinical trial.

    Dr. Kazem Kazempour, Amarex Clinical Research CEO, added, "We requested the FDA meeting to consult on the regulatory strategy for this treatment as a central nervous system product. FDA alignment with the strategy illustrates a positive step forward in finding a treatment for PCCD. Moreover, it is both exciting and gratifying to be working on this product for AIM. This is a new and serious COVID-induced disease indication for which there is currently no treatment."

    For additional information on the brain-related effects of Long COVID, go here:

    About AIM ImmunoTech

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The granting of the Company's meeting request concerning the use of Ampligen as a therapy for PCCD to the FDA's Division of Neurology is an initial step, and no assurance can be given that a meeting will ultimately lead to an approved trial. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of respiratory viruses, including SARS-CoV-2, as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  2. OCALA, Fla., Sept. 20, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today provided a status update on its Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal prophylactic therapy using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2). The proposed protocol for the AIM-sponsored study was submitted to the Oxford Research Ethics Committee (REC)/Medicines and Healthcare Regulatory Agency (MHRA) on September 10, 2021. A meeting is scheduled to review the study on September 24, and the response is expected by mid November.

    In addition, AIM and hVIVO continue to work to finalize the details of a Clinical Trial Agreement (CTA) and hope to announce its signing…

    OCALA, Fla., Sept. 20, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today provided a status update on its Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal prophylactic therapy using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2). The proposed protocol for the AIM-sponsored study was submitted to the Oxford Research Ethics Committee (REC)/Medicines and Healthcare Regulatory Agency (MHRA) on September 10, 2021. A meeting is scheduled to review the study on September 24, and the response is expected by mid November.

    In addition, AIM and hVIVO continue to work to finalize the details of a Clinical Trial Agreement (CTA) and hope to announce its signing soon. hVIVO is a subsidiary of Open Orphan plc, a rapidly growing specialist contract research organization and world leader in vaccine and antiviral testing using human challenge clinical trials.

    The study should move forward quickly once we have the expected approval of the REC/MHRA and our final agreement with hVIVO.

    The Phase 2a HCT is a single center, prospective, randomized, double-blind, placebo-controlled study of Ampligen administered intranasally to healthy adult male and female participants. In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow AIM to expedite the development process for Ampligen by ensuring full exposure of both the control group and the Ampligen group, so as to assess whether there is a prophylactic effect. A total of 64 participants are planned to participate in this study; 32 participants will be randomized and inoculated with influenza A/Perth/16/2009 (H3N2) and 32 participants will be randomized and inoculated with HRV-16 for an estimated total of 64 evaluable participants. In each group, 16 participants will be receiving Ampligen and 16 participants will be receiving placebo.

    A successful Phase 2a study could also help establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

    AIM CEO Thomas K. Equels, commented, "We are excited to advance this Human Challenge Trial using Ampligen.  Assuming we are successful, we believe this trial could have significant implications in the fight against infectious, viral respiratory diseases and future pandemics. Specifically, there is a major unmet need for a prophylactic therapy that could be easily administered to patients prior to exposure to respiratory viruses such as influenza, coronaviruses and even rhinoviruses such as the common cold.  We look forward to partnering with hVIVO on this landmark trial."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of respiratory viruses, including SARS-CoV-2, as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. No assurance can be given as to whether the REC will approve the proposed protocol or require revisions and, while AIM and hVIVO believe that they are in the final stages of completing the CTA, no assurance can be given that the CTA will be finalized. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  3. OCALA, Fla., Sept. 08, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that is has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Ampligen as a potential infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD).

    This will be a Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD. Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks. Amarex Clinical Research, an NSF International company, is managing the FDA submission and will manage the clinical…

    OCALA, Fla., Sept. 08, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that is has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Ampligen as a potential infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD).

    This will be a Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD. Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks. Amarex Clinical Research, an NSF International company, is managing the FDA submission and will manage the clinical trial.

    "This preliminary IND filing is not only a major milestone for the company, but also an important step forward for those individuals suffering from the debilitating long-term effects of COVID-19, including PCCD," said AIM CEO Thomas K. Equels. "We are highly encouraged by the outlook for this trial based on the safety data we have amassed around Ampligen, combined with initial data suggesting that Ampligen may improve cognitive function among patients with PCCD. We look forward to reporting additional near-term milestones, as we advance Ampligen as a potential COVID-19 therapy."

    Developing an effective therapy is critical for relieving the socioeconomical impact of PCCD and its medical burden on the U.S. and global populations. People suffering from PCCD — including young adults — can suffer severe difficulties in concentrating, serious memory problems and inability to live an active lifestyle, unable to work, and even unable to perform everyday tasks. Recent coverage of this troubling emerging condition includes:

    Early data have indicated that patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program have reported improvements in ability to concentrate or focus. Based on early data and AIM's research, the company recently filed a provisional patent application for Ampligen as both an intravenous and intranasal therapy for PCCD.

    The company hopes to make additional announcements about developing Ampligen as a potential COVID-19 therapy in the near future.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of respiratory viruses, including SARS-CoV-2, as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  4. OCALA, Fla., Aug. 25, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today provided an update on the company's efforts to develop its drug Ampligen as a potential intranasal therapeutic for COVID-19, including the announcement of a new provisional patent application for Ampligen as both an intranasal and an intravenous therapy for what AIM describes as Post-COVID-19 Cognitive Dysfunction (PCCD).

    AIM has been working steadily to expand its COVID-19 patent portfolio. In addition to the new provisional patent application addressing compositions and methods for treating PCCD, in February 2020 the company filed multiple COVID-19-related provisional patient applications, which are now patent pending worldwide, for Ampligen as a COVID-19…

    OCALA, Fla., Aug. 25, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today provided an update on the company's efforts to develop its drug Ampligen as a potential intranasal therapeutic for COVID-19, including the announcement of a new provisional patent application for Ampligen as both an intranasal and an intravenous therapy for what AIM describes as Post-COVID-19 Cognitive Dysfunction (PCCD).

    AIM has been working steadily to expand its COVID-19 patent portfolio. In addition to the new provisional patent application addressing compositions and methods for treating PCCD, in February 2020 the company filed multiple COVID-19-related provisional patient applications, which are now patent pending worldwide, for Ampligen as a COVID-19 therapy and as a vaccine adjuvant. Developing an effective therapy is critical for relieving the socioeconomical impact of PCCD and its medical burden on the population. The people suffering from PCCD, including some young adults, are afflicted with severe difficulties in concentrating, serious memory problems and inability to live an active lifestyle, unable to work, and even unable to perform everyday tasks.

    Early data has demonstrated that patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program (EAP) have reported improvements in cognitive function, according to Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C.

    "The results of some individual symptoms are very dramatic," said Lapp, the EAP's lead investigator. "The results clearly show a significant reduction of one or more symptoms of PCCD in patients after the administration of Ampligen."

    Also, as recently noted in the Wall Street Journal, intranasal immunity to the SARS-Cov-2 virus may be a key to controlling the spread of COVID-19, especially the more contagious and deadly Delta variant, which can accumulate in nasal tissues even in individuals who have been vaccinated with currently available vaccines. AIM's leadership and scientific experts reached a similar conclusion in the early days of the COVID-19 outbreak, deciding then to make the development of intranasal Ampligen a major R&D goal.

    "There is a growing and significant need for effective therapies to treat COVID-19, both in the acute phase and its longer-term effects," said AIM CEO Thomas K. Equels. "We believe that Ampligen has the potential to activate the body's innate immune system to fight COVID-19 through its use as a front-line, early-onset therapeutic — which includes potentially reducing intranasal viral load, potentially curbing the spread of the disease and lessening its severity. We believe Ampligen also can play a role in treating Post-COVID-19 Cognitive Dysfunction. PCCD is one of the most common and disabling immediate after effects of acute COVID-19 infection."

    AIM's approach has been strategic and methodical:

    • In August 2020, AIM identified an effective in vitro model using human tracheal, bronchial epithelial cells at The Institute for Antiviral Research at Utah State University which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
    • In November 2020, AIM disclosed positive pre-clinical results from a test by Japan's National Institute of Infectious Diseases (NIID) This pre-clinical work determined that Ampligen, when used as a vaccine adjuvant, provided 100% survival in a pre-clinical rodent model of SARS-CoV as a surrogate model of SARS-CoV-2, in contrast to the control group, which demonstrated 100% mortality. The preclinical findings suggested Ampligen was generally well-tolerated by the experimental cohort.
    • In early 2021, AIM launched a Phase 1 intranasal safety study of Ampligen, testing the safety, tolerability and biological activity of Ampligen at increasing doses, in anticipation of testing its potential as an intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. In June 2021, AIM announced that there were no Severe Adverse Effects observed in the study at any dosage level, thus establishing that Ampligen was well-tolerated when administered intranasally in humans.
    • A June 2021 article in the medical journal Cancers stated that Ampligen has the potential to reduce the severity of COVID-19 by "activating the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells." The study's authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator for an Early Access Program at Erasmus Medical Center in the Netherlands, where Ampligen is being used to treat patients with late-stage pancreatic cancer.
    • In July 2021, AIM announced significant progress toward a Phase 2a Human Challenge Trial to test the intranasal prophylactic effect of Ampligen in separate Rhinovirus hRV and Influenza cohorts. The study is part of AIM's work to develop Ampligen as a potential therapy against SARS-CoV-2 and other respiratory viruses. The trial is expected to commence in Q4 2021.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of respiratory viruses, including SARS-CoV-2, as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

     



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  5. OCALA, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the second quarter ended June 30, 2021 and provides a business update.   

    Second Quarter 2021 Financial Highlights:

    As of June 30, 2021, AIM had cash, cash equivalents and marketable securities of $57.3 million, compared to $54.4 million as of December 31, 2020.

    Research and development expenses for the three months ended June 30, 2021 were $1.3 million, compared to $1.5 million for the three months ended June 30, 2020.

    General and administrative expenses for the three months ended June 30, 2021 were $2.1 million, compared to $1.7 million for the three months ended June 30, 2020.

    The net loss from operations for the…

    OCALA, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the second quarter ended June 30, 2021 and provides a business update.   

    Second Quarter 2021 Financial Highlights:

    As of June 30, 2021, AIM had cash, cash equivalents and marketable securities of $57.3 million, compared to $54.4 million as of December 31, 2020.

    Research and development expenses for the three months ended June 30, 2021 were $1.3 million, compared to $1.5 million for the three months ended June 30, 2020.

    General and administrative expenses for the three months ended June 30, 2021 were $2.1 million, compared to $1.7 million for the three months ended June 30, 2020.

    The net loss from operations for the three months ended June 30, 2021 was $5.9 million, or $0.12 per share, compared to $3.4 million, or $0.11 per share, for the three months ended June 30, 2020.

    Please refer to the full 10-Q for complete details.

    2021 Clinical and Business Highlights

    After several years of success in various studies and trials, AIM has decided to strategically narrow its focus to trials and activities that have the shortest path to potential FDA and EMA drug approval, thus putting energy into the tasks where clinical results suggest an opportunity for expedited success. AIM anticipates that these planned trials primarily will be AIM-sponsored and AIM-funded.

    Immuno-oncology

    Analyses of data collected in the Early Access Program at Erasmus Medical Center (Erasmus MC) in the Netherlands found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Based on these encouraging data, AIM is developing a protocol design and schema — in consultation with Amarex Clinical Research, Buffet Cancer Center at the University of Nebraska and Erasmus MC — to seek regulatory approval to initiate a Phase 2/3 clinical trial of Ampligen in the United States and/or the European Union.

    Multiple additional Ampligen clinical trials are underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including with checkpoint inhibitors:

    • Advanced Recurrent Ovarian Cancer - A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; enrollment has commenced, and 17 subjects have now commenced treatment. https://clinicaltrials.gov/ct2/show/NCT03734692
    • Stage 4 Metastatic Triple Negative Breast Cancer - Phase 1/2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. Eight patients were enrolled and treated. We await publication of data. https://www.clinicaltrials.gov/ct2/show/NCT03599453
    • Stage 4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver; 15 patients were enrolled and treated. We await publication of data. https://clinicaltrials.gov/ct2/show/NCT03403634
    • Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. https://clinicaltrials.gov/ct2/show/NCT03899987
    • Early-Stage Triple Negative Breast Cancer - Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. This study is recruiting patients and is designed for up to 24 patients. https://clinicaltrials.gov/ct2/show/NCT04081389

    COVID-19

    In January, AIM entered into a Sponsor Agreement with the Centre for Human Drug Research (CHDR), a foundation located in Leiden in the Netherlands, to manage a Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. AIM funded and sponsored the study. This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. All patients had completed treatment by June 2021 and the interim results reported no Severe Adverse Events at any dosage level. The object was to establish safety for intranasal Ampligen as a potential broad spectrum prophylaxis for respiratory viruses, including SARS-CoV-2. Following the completion of the Phase 1 dosing, and based on its positive interim results, in July 2021 AIM signed a Reservation and Start-Up Agreement with hVIVO, reserving space in hVIVO's quarantine facility to sponsor a Phase 2a Human Challenge Trial (HCT) to test Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (a common cold virus) and Influenza as challenge viruses. This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The trial is expected to commence in Q4 2021. The object is to establish Ampligen's potential as a broad spectrum prophylaxis for respiratory viruses, including SARS-CoV-2.

    In an HCT, subjects are intentionally exposed to particular disease pathogens to test how the diseases will respond to the test treatment. An HCT will allow the Company to expedite the development process for Ampligen by ensuring that all subjects in both the control group and the Ampligen group are exposed to the target pathogen, so as to assess whether there is a prophylactic effect. A successful Phase 2a HCT study could also establish Ampligen's potential as a prophylaxis against future viral variants and future novel respiratory viruses for which there are no current vaccines or therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

    Immuno-oncology / COVID-19

    In June, Ampligen was featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2. The study's authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19, which has so far caused more than 4.3 million deaths globally. The full journal article is titled: "Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?Cancers is a peer-reviewed, open access journal of oncology published semimonthly online by MDPI. The study's authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator for an Early Access Program at Erasmus Medical Center in the Netherlands.

    Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19

    On January 6, AIM announced that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) in the U.S. dosed its first "Long Hauler" patient with the drug Ampligen, marking a significant milestone in AIM's efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are now in treatment and AIM intends to provide further updates as the trial progresses.

    "We continued to make positive clinical and operational progress during the second quarter," commented, Thomas K. Equels, CEO of AIM ImmunoTech. "With our strong balance sheet, we are well positioned to execute on our corporate strategy and advance our clinical trials to meaningful milestones that we believe will drive significant shareholder value. We anticipate reporting material developments throughout the remainder of this year and through 2022. We remain extremely encouraged by the outlook for Ampligen."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA.   We are in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of these conditions. The Company cannot assure that its many studies will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Investor Relations Contact:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com        

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5d6e764a-b8fa-4e05-839c-1c7695edfcc9



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  6. OCALA, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that CEO Thomas K. Equels has been appointed to the Board of Directors of BioFlorida Inc., the state's life sciences industry association.

    "The life sciences industry in Florida is vibrant, and we're excited to welcome Thomas Equels of AIM ImmunoTech, Mark Friedman, PhD of Axogen, Geoff Green of Longeveron, Adam Grossman of ADMA Biologics, and Joe Sardano of Sensus Healthcare," said Nancy Bryan, President and CEO of BioFlorida, which announced the new board members last week. "Our new board members are leaders in their fields with a passion to unite with our diverse Board of Directors representing the various sectors and regions in Florida with a…

    OCALA, Fla., Aug. 16, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that CEO Thomas K. Equels has been appointed to the Board of Directors of BioFlorida Inc., the state's life sciences industry association.

    "The life sciences industry in Florida is vibrant, and we're excited to welcome Thomas Equels of AIM ImmunoTech, Mark Friedman, PhD of Axogen, Geoff Green of Longeveron, Adam Grossman of ADMA Biologics, and Joe Sardano of Sensus Healthcare," said Nancy Bryan, President and CEO of BioFlorida, which announced the new board members last week. "Our new board members are leaders in their fields with a passion to unite with our diverse Board of Directors representing the various sectors and regions in Florida with a collective goal to advance the impressive, diverse life sciences ecosystem."

    BioFlorida is the voice of Florida's life sciences industry, representing 6,700 establishments and research organizations in the biopharmaceuticals, medical technology, healthIT and bioagriculture sectors that collectively employ nearly 94,000 Floridians. Members of the BioFlorida network include emerging and established life science companies, universities, research institutions, hospitals, medical centers, incubators, economic development agencies, investors and service providers.

    "AIM ImmunoTech Inc. is working hard to develop potential therapies for a number of dread diseases — from deadly cancers to COVID-19 — and we're proud to be able to do this work in Florida," said Equels. "I'm honored to have been named as a member of the Board of Directors of BioFlorida."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    About BioFlorida Inc.

    BioFlorida is the voice of Florida's life science industry, representing 6,700 establishments and research organizations in the biopharmaceutical, medical technology, and bioagriculture sectors that collectively employ 94,000 Floridians. BioFlorida's member driven initiatives provide a strong business climate for the advancement of innovative products and technology that improve lives and promote economic benefits to the state.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  7. OCALA, Fla., July 09, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has signed a contract to sponsor a Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza.

    This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The trial is expected to commence in Q4 2021.

    A successful Phase 2a study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel…

    OCALA, Fla., July 09, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has signed a contract to sponsor a Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza.

    This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The trial is expected to commence in Q4 2021.

    A successful Phase 2a study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

    In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow AIM to expedite the development process for Ampligen by ensuring high infection rates for subjects who receive the drug, therefore also ensuring large data sets with potentially statistically significant results.

    This Phase 2a study will come in the wake of AIM's recent announcement that all subjects have completed treatment in the company's Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level. A final study report is expect in the third quarter of 2021.

    Unlike other drugs tailored to combat specific diseases, Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning that Ampligen delivered via an intranasal device could be an effective preventive therapy for people who may be exposed to, or have recently been exposed to, a respiratory virus such as influenza, or even common coronaviruses and rhinoviruses (like the common cold). Success against these common viruses could also indicate that an Ampligen prophylaxis could help blunt the spread of infection from lethal coronaviruses, as well as other serious viruses. This Phase 2a study will test this proposition in humans.

    AIM CEO Thomas K. Equels, commented: "It is our belief that Ampligen's mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic. The ability to do a Human Challenge Trial using hRV and Influenza allows us to test in humans Ampligen's potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses."

    Cathal Friel, Executive Chairman of Open Orphan, stated: "We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product and to demonstrate our expertise in testing vaccines and antivirals using our world-leading portfolio of human challenge models. While the pandemic has undoubtedly inflicted a lot of loss and suffering globally, it has also taught us a valuable lesson in pandemic preparedness. It is my belief therefore that the infectious disease market has been utterly transformed and is going to grow exponentially in the years ahead. Challenge studies are a key weapon in the arsenal against infectious diseases as they can bring effective treatments and vaccines to the market both quicker and faster than they could otherwise."

    An Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruise, cargo or military ships; people on commercial airplanes; and service personnel in close quarters on military installations.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    About Open Orphan plc

    Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organizations.

    Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialized virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world's first COVID-19 human challenge study model as part of the Human Challenge Program and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

    Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

    Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of respiratory viruses, including SARS-CoV-2, as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  8. OCALA, Fla., July 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it will host an investor update webcast at 11:00 a.m. Eastern Time on Wednesday, July 14, 2021, to discuss recent accomplishments and upcoming milestones. Investors and other interested parties are invited to submit questions to management prior to the call's start via email to aim@crescendo-ir.com.

    The webcast may be accessed at https://www.webcaster4.com/Webcast/Page/2605/41875 or on the Company's website at https://aimimmuno.com/events-presentations/. For those unable to participate at that time, a replay of the webcast will be available until Thursday, July 14, 2022 on the Company's website.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc…

    OCALA, Fla., July 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it will host an investor update webcast at 11:00 a.m. Eastern Time on Wednesday, July 14, 2021, to discuss recent accomplishments and upcoming milestones. Investors and other interested parties are invited to submit questions to management prior to the call's start via email to aim@crescendo-ir.com.

    The webcast may be accessed at https://www.webcaster4.com/Webcast/Page/2605/41875 or on the Company's website at https://aimimmuno.com/events-presentations/. For those unable to participate at that time, a replay of the webcast will be available until Thursday, July 14, 2022 on the Company's website.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  9. OCALA, Fla., June 21, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that all subjects have completed treatment in the Company's Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A final study report is expect in the third quarter of 2021.

    A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.

    With these positive preliminary results in hand, the Company is now moving forward with the initial planning and negotiations for a follow-up Phase…

    OCALA, Fla., June 21, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that all subjects have completed treatment in the Company's Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A final study report is expect in the third quarter of 2021.

    A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.

    With these positive preliminary results in hand, the Company is now moving forward with the initial planning and negotiations for a follow-up Phase 2 study testing Ampligen as a potential broad-spectrum respiratory virus prophylaxis. Unlike other drugs tailored to combat specific diseases, Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning that Ampligen delivered via an intranasal device could be an effective preventive therapy for people who may be exposed to, or have recently been exposed to, a respiratory virus such as influenza, or even common coronaviruses and rhinoviruses (like the common cold). This Phase 2 study will test this proposition in humans. A successful Phase 2 study could also establish Ampligen as a potential prophlyaxis against future viral variants and future novel respiratory viruses for which there are no current therapies. Moreover, an Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruises, cargo or miltary ships; people on commercial airplanes; and service personnel in close quarters on military installations.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company is in the preliminary stages of planning a Phase 2 Study of Ampligen as a broad-spectrum respiratory virus prophylaxis. No assurance can be given as to if or when such study will occur, the cost of such study or whether it will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of respiratory viruses, including SARS-CoV-2, as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8888d6ec-da99-464b-a903-f5d715e997c1



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  10. OCALA, Fla., June 14, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that its drug Ampligen has been featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2.

    The study's authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19, which has so far caused more than 3.7 million deaths globally. According to the data presented in the publication, "Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells", including:

    • Stimulation of interferon…

    OCALA, Fla., June 14, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that its drug Ampligen has been featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2.

    The study's authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19, which has so far caused more than 3.7 million deaths globally. According to the data presented in the publication, "Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells", including:

    • Stimulation of interferon regulatory factors and activation of the interferon signaling pathway
    • Production of immunomodulatory activity
    • Induction of the expression of MHC class I and II histocompatibility

    The full journal article is titled: "Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?" Cancers is a peer-reviewed, open access journal of oncology published semimonthly online by MDPI. The study's authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator for an Early Access Program at Erasmus Medical Center in the Netherlands, where Ampligen is being used to treat patients with late-stage pancreatic cancer.

    "I do think Ampligen fully deserves to be developed for potential approval in the treatment of viral infections, including COVID-19. The stimulation of the innate immunity by Ampligen is potentially important in combating aggressive viral infections and could save many lives," said Prof. C.H.J. van Eijck.

    Additionally, AIM was previously granted a patent by the Netherlands. The granted claims include, but are not limited to, the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors (e.g. pembrolizumab, nivolumab). The patent expires December 19, 2039, or 20 years from the date of filing, December 20, 2019.

    "AIM is extremely pleased with the tremendous progress we are making in the Netherlands to advance Ampligen as a therapuetic," said AIM CEO Thomas K. Equels. "Prof. van Eijck and his team are preeminent in their field. The data they present is compelling. Also, this patent issuance by the Netherlands is another successful step in our drug development program."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective as an immuno-oncology therapeutic or in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. Additionally, no assurances can be given that granted patent applications will result in approved products or therapies. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  11. OCALA, Fla., May 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has entered into a two-year extension of its Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (Smoore), a subsidiary of Smoore International Holdings Limited (HKEX: 6969), with the goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases.

    AIM entered into the agreement on April 1, 2020, to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. On parallel paths, over the past year, Smoore has focused on the development of a personal inhalation device…

    OCALA, Fla., May 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has entered into a two-year extension of its Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (Smoore), a subsidiary of Smoore International Holdings Limited (HKEX: 6969), with the goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases.

    AIM entered into the agreement on April 1, 2020, to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. On parallel paths, over the past year, Smoore has focused on the development of a personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA. Contemporaneously, AIM has studied the safety and efficacy of Ampligen using an ex vivo 3D model in primary human respiratory epithelial cells at Utah State University, which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, and conducted intranasal safety testing. AIM hopes to commence inhalation safety testing before year-end.

    "With Smoore's concept for an Ampligen inhalation delivery device ready to be developed, and Ampligen's track record of both safety and efficacy, we believe AIM is well positioned to move forward with our goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases," said AIM CEO Thomas K. Equels. "We are in the process of planning a Phase 1/2 inhalation clinical study on a parallel track with Smoore's device development testing."

    ‘Application of vaping technology in healthcare and pharmaceutical fields is one of our R&D focus. We are really happy to partner with AIM to explore applications of advanced atomization technology in medical inhalation therapy," Dr. Zhiqiang Shi, Chief Scientist and Director of Global R&D of Smoore, commented. "We will coordinate our device development work along with our partner's plan and the regulation needs to move into next phase testing on schedule.'   

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth herein speak only as of the date hereof. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and, if so, whether the Smoore's delivery technology will prove effective, and no assurance can be given that it will be the case. The agreement with Smoore is to preliminarily study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. The Company is in the process of planning a Phase 1/2 study of Ampligen as an inhalation therapy. No assurance can be given that the preliminary Smoore study or the Phase 1/2 study will proceed or will prove promising or that the Company and Smoore will enter into further agreements. Even if Ampligen proves effective in combating the virus, no assurance can be given that the Company's actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make its efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies the Company is relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. The information found on the Company's website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  12. OCALA, Fla., May 26, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 3 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events.

    This is consistent with results in the first two cohorts of the study and at escalating doses.The study protocol called for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 μg of Ampligen, subjects in Cohort 2 received 200 μg of Ampligen and subjects in Cohort 3 received 500 μg. The study is already proceeding with Cohort 4, with subjects receiving 1250 μg.

    The Centre…

    OCALA, Fla., May 26, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 3 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events.

    This is consistent with results in the first two cohorts of the study and at escalating doses.The study protocol called for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 μg of Ampligen, subjects in Cohort 2 received 200 μg of Ampligen and subjects in Cohort 3 received 500 μg. The study is already proceeding with Cohort 4, with subjects receiving 1250 μg.

    The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the Phase 1 clinical study AMP-COV-100 (CHDR2049), titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects." AIM is sponsoring and funding the clinical study.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or continue to yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  13. OCALA, Fla., May 18, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the first quarter ended March 31, 2021.   

    • As of March 31, 2021, AIM had cash, cash equivalents and marketable securities of $63.6 million, compared to $54.4 million as of December 31, 2020.

    • Research and development expenses for the three months ended March 31, 2021 were $1.4 million, compared to $0.9 million for the three months ended March 31, 2020.

    • General and administrative expenses for the three months ended March 31, 2021 were $2.1 million, compared to $2.3 million for the three months ended March 31, 2020.

    • The net loss from operations for the three months ended March 31, 2021 was $3.6 million, or $0.08 per share, compared to…

    OCALA, Fla., May 18, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the first quarter ended March 31, 2021.   

    • As of March 31, 2021, AIM had cash, cash equivalents and marketable securities of $63.6 million, compared to $54.4 million as of December 31, 2020.



    • Research and development expenses for the three months ended March 31, 2021 were $1.4 million, compared to $0.9 million for the three months ended March 31, 2020.



    • General and administrative expenses for the three months ended March 31, 2021 were $2.1 million, compared to $2.3 million for the three months ended March 31, 2020.



    • The net loss from operations for the three months ended March 31, 2021 was $3.6 million, or $0.08 per share, compared to $3.8 million, or $0.22 per share, for the three months ended March 31, 2020.

    "I'm extremely proud of the progress we have made throughout the first quarter," commented Thomas K. Equels, CEO of AIM ImmunoTech. "We have established a strong foundation of pre-clinical and clinical data with respect to the development of therapeutics aimed to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19. With our solid financial standing, we intend to execute on our corporate strategy and aggressively move forward with our clinical programs that address critical unmet medical needs. We have reached many important milestones, are encouraged by the outlook for AIM and look forward to providing meaningful updates along the way."

    Please refer to the full 10-Q for complete details. Additionally, please refer to AIM's most recent Company Presentation for updates on ongoing clinical studies.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of

    therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Investor Relations Contact:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  14. OCALA, Fla., May 03, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces that Thomas K. Equels, CEO of AIM ImmunoTech, participated in a ‘Fireside Chat' video interview with Ed Woo, Director of Research & Senior Analyst at Ascendiant Capital Markets.

    During the Fireside Chat, Equels discusses recent accomplishments, key upcoming goals and milestones, as well as the financial and operational outlook for AIM's business. A link to the interview is available on the company's website at [https://aimimmuno.com/FiresideChat050321].

    About AIM ImmunoTech Inc.
    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases…

    OCALA, Fla., May 03, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces that Thomas K. Equels, CEO of AIM ImmunoTech, participated in a ‘Fireside Chat' video interview with Ed Woo, Director of Research & Senior Analyst at Ascendiant Capital Markets.

    During the Fireside Chat, Equels discusses recent accomplishments, key upcoming goals and milestones, as well as the financial and operational outlook for AIM's business. A link to the interview is available on the company's website at [https://aimimmuno.com/FiresideChat050321].

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release and the video accessible by the link provided herein, contains forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth herein speak only as of the date hereof. The company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that the company's actions toward proving this will be given first priority or that other treatments that eventually prove capable will not make our efforts ultimately unproductive. The company recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the presentation. No assurance can be given that patent applications will be granted. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The company cannot assure that its potential foreign operations will not be adversely affected by these risks.

    Investor Relations Contact:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  15. OCALA, Fla., April 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 2 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events (SAE). AIM also reported no SAEs in Cohort 1. The study will proceed with enrollment into Cohort 3.

    The clinical study is crucial for the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), titled "A Phase…

    OCALA, Fla., April 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 2 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events (SAE). AIM also reported no SAEs in Cohort 1. The study will proceed with enrollment into Cohort 3.

    The clinical study is crucial for the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects." AIM is sponsoring and funding the clinical study.

    The study protocol calls for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 μg of Ampligen, while subjects in Cohort 2 received 200 μg of Ampligen. The dosage will escalate to 500 μg in the next cohort, Cohort 3, with the highest level of 1250 μg planned for Cohort 4.

    AIM will continue to provide interim updates on the clinical trial.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  16. OCALA, Fla., April 07, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, reporting no serious adverse events, and paving the way for escalation of the dose in Cohort 2. The trial is a critical step in the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety…

    OCALA, Fla., April 07, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, reporting no serious adverse events, and paving the way for escalation of the dose in Cohort 2. The trial is a critical step in the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects." AIM is the sponsor and is funding the clinical study.

    The study protocol calls for the enrollment of eight healthy subjects in each of four Cohorts to receive Ampligen. In addition, two healthy subjects in each Cohort will receive placebo, for a total of 40 healthy subjects. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. This study will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The protocol design is for subjects in Cohort 1 to receive 75 μg of Ampligen or a matching placebo, Cohort 2 to receive 200 μg of Ampligen or a matching placebo, Cohort 3 to receive 500 μg of Ampligen or a matching placebo, and Cohort 4 to receive 1250 μg of Ampligen or a matching placebo.

    "AIM is pleased with the positive results in this first cohort. This Phase 1 safety study is designed to test the parameters of Ampligen's intranasal tolerance before commencing a Phase 2 study. While the higher doses that we plan to test in this Phase 1 trial may or may not be well tolerated, we plan on moving quickly into Phase 2 studies with the doses that have successfully passed these Phase 1 tests, such as the dose used in Cohort 1." said AIM CEO Thomas K. Equels.

    AIM will continue to provide interim updates on the clinical trial.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  17. OCALA, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the fiscal year ended December 31, 2020 and provides a business update.

    2020 Financial Highlights

    As of December 31, 2020, AIM had cash, cash equivalents and marketable securities of $54.4 million, compared with $8.8 million as of December 31, 2019.

    Research and development expenses for 2020 were $5.7 million, compared with $4.7 million for 2019. General and administrative expenses for 2020 were $8.7 million, compared with $7.0 million for 2019.

    The net loss from operations for 2020 was $14.4 million, or $0.45 per share, compared with $9.4 million, or $2.58 per share, for 2019.

    Please refer to the full 10-K for complete details…

    OCALA, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the fiscal year ended December 31, 2020 and provides a business update.

    2020 Financial Highlights

    As of December 31, 2020, AIM had cash, cash equivalents and marketable securities of $54.4 million, compared with $8.8 million as of December 31, 2019.

    Research and development expenses for 2020 were $5.7 million, compared with $4.7 million for 2019. General and administrative expenses for 2020 were $8.7 million, compared with $7.0 million for 2019.

    The net loss from operations for 2020 was $14.4 million, or $0.45 per share, compared with $9.4 million, or $2.58 per share, for 2019.

    Please refer to the full 10-K for complete details.

    Update on COVID-19 Pandemic Initiatives

    AIM has been actively engaged in determining whether its drug Ampligen could be an effective treatment for COVID-19. Due to Ampligen's established record of antiviral activity against closely related coronaviruses, AIM believes there is a reasonable probability that its antiviral effects against SARS-CoV-1 will extend to SARS-CoV-2. In animal studies, Ampligen demonstrated complete protection (100% survival) against SARS-CoV-1. This created a compelling case for pre-clinical and clinical testing of Ampligen against SARS-CoV-2 to evaluate Ampligen as a potential prophylactic and early-onset treatment for COVID-19, and, as discussed below, such human clinical trials are now underway.

    AIM reached several significant COVID-19 milestones in 2020 and early 2021:

    • AIM announced that it had identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, with the results showing that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
    • AIM reported that Roswell Park Comprehensive Cancer Center's Phase 1/2a study evaluating the two-drug combination of AIM's Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study. Based upon that, in March 2020, the company also announced an Institutional Review Board amendment to add a single-agent Ampligen arm to the study.
    • AIM announced that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with Ampligen.
      • Dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod). Additional patients are in the process of being enrolled. 
    • Entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, for the AMP-COV-100 (CHDR2049) clinical study in the Netherlands on the safety of AIM's drug Ampligen as an intranasal therapy.
      • Received approval from the Ethics Committee in the Netherlands to commence its Phase 1 clinical study.
      • Dosed the first healthy subjects in its Phase 1 clinical study.

    Ampligen has shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the only drug approved for severe CFS in the world. As witnessed in the prior SARS epidemic of 2002-03, 27% of hospitalized survivors met the U.S. CDC criteria for chronic fatigue syndrome. More than 30 million people in the United States have been infected with SARS-CoV-2, representing a considerable number of people facing potential COVID-induced ME/CFS-like illness in their future. All these facts support our optimism and hopes for the development of a therapy for COVID-induced chronic fatigue.

    Update on Cancer Clinical Trials/Programs

    Ampligen demonstrated the potential for standalone efficacy in the clinical setting in a number of solid tumors. Six Ampligen clinical trials are currently underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.

    AIM reported receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program treating 27 subjects with advanced pancreatic adenocarcinoma conducted at Erasmus University Medical Center in the Netherlands. Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using AIM's drug Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Median survival was 7.0 months higher in the Ampligen arm as compared to the historical controls. A manuscript for publication is being prepared by the Erasmus MC team.

    Towards this end, AIM intends to seek FDA authorization for a follow-up pancreatic cancer Phase 2/3 clinical trial and cancer centers have already expressed interest in serving as clinical sites.

    Additionally, Ampligen was awarded an FDA Orphan Drug Designation for the treatment of pancreatic cancer, and a European Medicines Agency orphan medicinal product designation for pancreatic cancer. AIM intends to seek FDA fast-track status for pancreatic cancer. The company will promptly update stockholders and the market as more information on these studies becomes available.

    "We are proud to have achieved a number of important milestones throughout 2020 and believe we have a number of key upcoming catalysts. We are conducting important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs within large addressable markets.  We are in a solid financial position that enables us to continue to execute on our corporate strategy without relying on third-party grants or assistance. Our strong balance sheet also allows us to accelerate our clinical trials without the need to wait for grants. We look forward to updating stockholders and the market as developments unfold," commented Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Investor Relations Contact:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  18. OCALA, Fla., March 22, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer Center (Roswell Park) has approved a protocol amendment to Roswell Park's ongoing Phase 1/2a study evaluating the two-drug combination of AIM's Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19.

    The IRB-approved amendment calls for randomization of an additional twenty patients. Ten of these patients will receive a single dose of Ampligen, but no interferon treatment, and the other ten will receive best available care only. Ampligen alone has a generally well-tolerated safety profile with lower…

    OCALA, Fla., March 22, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer Center (Roswell Park) has approved a protocol amendment to Roswell Park's ongoing Phase 1/2a study evaluating the two-drug combination of AIM's Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19.

    The IRB-approved amendment calls for randomization of an additional twenty patients. Ten of these patients will receive a single dose of Ampligen, but no interferon treatment, and the other ten will receive best available care only. Ampligen alone has a generally well-tolerated safety profile with lower risk of adverse events than is generally expected with interferon therapy.

    "We are excited to see Ampligen tested not only as part of an antiviral treatment combination for COVID-19 among cancer patients, but also as a possible standalone therapy for this terrible virus," said AIM CEO Thomas K. Equels. "An early-onset treatment is especially critical for cancer patients, who face significantly increased risk of severe symptoms or death."

    AIM previously announced in November 2020 that the first patient had been enrolled and received treatment in Roswell Park's study. Funding for the clinical trial is provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.

    Full details about this trial under way at Roswell Park, led by co-Principal Investigators Drs. Brahm Segal and Pawel Kalinski, are available at ClinicalTrials.gov.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. In this regard, the Roswell Park Clinical Trial Agreement is one of the first steps and no assurance can be given as to whether the Roswell Park trial and/or subsequent trials will prove successful. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies the Company is relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on the Company's website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  19. OCALA, Fla., March 10, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, AIM's Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC.

    The conference will take place March 17-19, from 9:00 am to 5:00 pm ET, and feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers, both domestically and internationally.

    During this virtual conference, AIM ImmunoTech will present along with many other important voices in the health care industry. To attend and access exclusive content, sign up to become an M-Vest…

    OCALA, Fla., March 10, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, AIM's Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC.

    The conference will take place March 17-19, from 9:00 am to 5:00 pm ET, and feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers, both domestically and internationally.

    During this virtual conference, AIM ImmunoTech will present along with many other important voices in the health care industry. To attend and access exclusive content, sign up to become an M-Vest member HERE and stay tuned for more updates. The presentation will be available on the investor relations section of AIM's website at https://aimimmuno.com/events-presentations/.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com





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  20. OCALA, Fla., March 08, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM's drug Ampligen as a potential intranasal therapy. AIM's 's goal is to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

    Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study, titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects."

    The current study plans…

    OCALA, Fla., March 08, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM's drug Ampligen as a potential intranasal therapy. AIM's 's goal is to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

    Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study, titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects."

    The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. The trial is designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.

    The prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

    Thomas K. Equels, CEO of AIM stated, "We greatly appreciate the tremendous efforts of the entire team at CHDR to help us initiate our Phase 1 study of Ampligen as a potential intranasal therapy. Our objective is to expedite the development of Ampligen as a potential prophylaxis or treatment for COVID-19. Prior results of in vitro modelling were promising, and we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19. We look forward to providing further updates as this critical trial progresses."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  21. OCALA, Fla., March 04, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, will be presenting at the H.C. Wainwright Life Sciences Conference to be held virtually between March 9-10, 2021.

    AIM's presentation will be available on-demand to registered attendees via the conference platform beginning Tuesday, March 9, 2021, at 7:00 AM Eastern Time. The webcast will be accessible here, and the presentation will be available on the investor relations section of AIM's website at https://aimimmuno.com/events-presentations/. Management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered…

    OCALA, Fla., March 04, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, will be presenting at the H.C. Wainwright Life Sciences Conference to be held virtually between March 9-10, 2021.

    AIM's presentation will be available on-demand to registered attendees via the conference platform beginning Tuesday, March 9, 2021, at 7:00 AM Eastern Time. The webcast will be accessible here, and the presentation will be available on the investor relations section of AIM's website at https://aimimmuno.com/events-presentations/. Management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  22. OCALA, Fla., Feb. 24, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that its subsidiary, NV Hemispherx Biopharma Europe, has received formal notification from the European Commission (EC) approving the company's Orphan Medicinal Product Application for Ampligen as a treatment for pancreatic cancer.

    Medications that have been designated as Orphan products by the European Medicines Agency (EMA), once commercially approved in the European Union (EU), receive benefits including up to ten years of protection from market competition from similar medicines with similar active component and indication for use that are not shown to be clinically superior.

    AIM announced earlier this month that the Committee for Orphan…

    OCALA, Fla., Feb. 24, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that its subsidiary, NV Hemispherx Biopharma Europe, has received formal notification from the European Commission (EC) approving the company's Orphan Medicinal Product Application for Ampligen as a treatment for pancreatic cancer.

    Medications that have been designated as Orphan products by the European Medicines Agency (EMA), once commercially approved in the European Union (EU), receive benefits including up to ten years of protection from market competition from similar medicines with similar active component and indication for use that are not shown to be clinically superior.

    AIM announced earlier this month that the Committee for Orphan Medicinal Products of the EMA had recommended that Ampligen receive the designation for pancreatic cancer. The company has now received the official approval of that designation.

    Prof. Casper van Eijck, M.D. Ph.D., the lead investigator for the expanded access program (EAP) for Ampligen at Erasmus Medical Center, stated, "We are pleased to report that the EMA has approved Ampligen for orphan medicinal product designation. Pancreatic cancer is the seventh leading cause of cancer-related deaths worldwide with over 458,000 worldwide cases of pancreatic cancer in 2018 alone. Despite advancements in the detection and management of pancreatic cancer, the 5-year survival rate is only 5-10%. Due to the positive and statistically significant survival results, versus historical controls, that we observed when using Ampligen in patients with locally advanced/metastatic pancreatic cancer–after systemic chemotherapy–we believe that Ampligen has the potential to be a meaningful extension of the standard of care for advanced pancreatic cancer. We are currently writing the manuscript describing the results of our study and are planning to investigate Ampligen further in the follow-up pancreatic cancer Phase 2/3 clinical trial and in a Phase 1 trial in combination with check point inhibitors at Erasmus Medical Center."

    Kazem Kazempour, Ph.D., at Amarex Clinical Research, commented, "We are working closely with AIM in the United States to attain FDA ‘fast-track' status, as well as possible FDA ‘breakthrough' designations, and to obtain IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof. van Eijck, and also at major cancer research centers in the United States."

    "Orphan medicinal product designation in the EU and in the US is a critical milestone in AIM's ongoing efforts to develop Ampligen as a treatment for pancreatic cancer," said AIM CEO Thomas K. Equels. "Pancreatic cancer is one of the deadliest cancers because, far too often, it is not diagnosed until Stage IV, when the disease is so far along that there are limited therapeutic options. We at AIM hope that Ampligen can one day help add precious time to the lives of many people suffering from pancreatic cancer."

    Orphan medicinal product designations promote the clinical development of drugs that target rare life-threatening conditions, and which are expected to provide significant therapeutic advantage over existing treatments. An estimated 466,000 people died of pancreatic cancer worldwide in 2020, according to the World Health Organization. The five-year survival rate is only 5-10 percent.

    Sponsors who obtain EMA orphan designation "benefit from protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market," according to the EMA. Fee reductions are also available depending on circumstances. The EMA has a comprehensive explanation of the benefits of Orphan Drug Designation (ODD) on its website.

    The EMA designation follows a similar approval from the U.S. Food and Drug Administration (FDA), which also awarded AIM with orphan drug designation status for Ampligen as a treatment for pancreatic cancer.

    The FDA orphan designation followed the company's September 22, 2020 announcement of statistically significant positive pancreatic cancer survival benefit in the Ampligen arm as compared to a historical control cohort seen in a multi-year Early Access Program conducted at Erasmus University Medical Center in the Netherlands. The use of Ampligen following the current standard of care for pancreatic cancer (FOLFIRINOX) yielded an overall survival of 19 months, 7.9 months greater than FOLFIRINOX treatment alone.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate," and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Orphan Medicinal Production Designation, while beneficial, does not assure commercial approval. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. No assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    Photos accompanying this announcement are available at

    https://www.globenewswire.com/NewsRoom/AttachmentNg/073bac80-5e74-4303-b7bf-43872b01fc16

    https://www.globenewswire.com/NewsRoom/AttachmentNg/dd5ef302-9bce-4e00-b38a-01f6c863f37b



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  23. OCALA, Fla., Feb. 16, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, a critical step in the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    Earlier this year, the company announced that it had entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) trial. Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.

    The current…

    OCALA, Fla., Feb. 16, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, a critical step in the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    Earlier this year, the company announced that it had entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) trial. Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.

    The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. This will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.

    "We are delighted and honored to receive Ethics Committee approval, an important step toward initiation of the trial," said AIM CEO Thomas K. Equels. "We are on track for site initiation later this month and expect to begin enrolling participants in the study during the first quarter of 2021. Importantly, our prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage concentrations. As a result, we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19 and are excited to commence safety tests of potential dosing regimens."

    Dr. Matthijs Moerland, principal investigator at CHDR: "We're very happy helping AIM with this important step. Together with AIM's study team, we feel we have not only designed a trial evaluating Ampligen's intranasal safety profile, but also yielding important mechanistic data on the compound's immunomodulatory activities."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3611a63e-e942-4a1e-9f9e-b463ef0a224a



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  24. OCALA, Fla., Feb. 10, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the Dutch Health and Youth Care Inspectorate (IGJ) has approved treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program (EAP) at Erasmus Medical Center in the Netherlands. Subject to further authorization we plan to treat up to 16 pancreatic cancer patients with rintatolimod (Ampligen) under the EAP, which follows the success of a previous multi-year Ampligen EAP for pancreatic cancer patients at Erasmus MC. The new approval was designed to include several patients treated under the previous EAP, who are still alive despite their diagnoses several years ago of locally advanced or metastatic pancreatic cancer…

    OCALA, Fla., Feb. 10, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the Dutch Health and Youth Care Inspectorate (IGJ) has approved treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program (EAP) at Erasmus Medical Center in the Netherlands. Subject to further authorization we plan to treat up to 16 pancreatic cancer patients with rintatolimod (Ampligen) under the EAP, which follows the success of a previous multi-year Ampligen EAP for pancreatic cancer patients at Erasmus MC. The new approval was designed to include several patients treated under the previous EAP, who are still alive despite their diagnoses several years ago of locally advanced or metastatic pancreatic cancer.

    AIM announced on September 22, 2020 that the initial EAP had demonstrated statistically significant positive pancreatic cancer survival benefits in its Ampligen arm, as compared to a historical control cohort. The use of Ampligen, following the current standard of care for pancreatic cancer (FOLFIRINOX), yielded an overall survival of 19 months, or 7.9 months greater than FOLFIRINOX treatment alone. This new group will help focus on immunological markers which will aid in identifying high-level Ampligen responders.

    "We are extremely pleased to continue our study in pancreatic cancer patients with Ampligen, given the hopeful previous results," said Prof. Casper van Eijck, MD, PhD, the lead investigator for the EAP at Erasmus MC. "By more selectively including patients for this treatment, we hope to better define the ultimate application area. We are grateful to AIM ImmunoTech Inc. for their constructive contribution to enabling this treatment in this aggressive cancer."

    This announcement is an important step in AIM's ongoing efforts to expand its pancreatic cancer treatment program, as data gathered in the new study may assist in the company's plans to transition into a clinical trial with clinical sites in the European Union (EU) and the United States. Both Erasmus MC and the Buffett Cancer Center at the University of Nebraska Medical Center (K. Klute, MD, M.A. Hollingsworth, PhD) have tentatively agreed to serve as clinical trial sites. Additionally, AIM announced in December 2020 that the U.S. Food and Drug Administration had granted Orphan Drug Designation to Ampligen as a treatment for pancreatic cancer; the European Medicines Agency (EMA) recently recommended to the European Commission (EC) that AIM's wholly owned subsidiary – Hemispherx Biopharma Europe – receive a similar designation in the EU for Ampligen in pancreatic cancer, and the company awaits a final EC decision.

    AIM's planned next steps in its pancreatic cancer program include filing an Investigational New Drug (IND) application in the United States and a Clinical Trial Application (CTA) in the EU to move forward in the study of Ampligen for treating this disease. The company is also exploring the possibility of applying for Fast Track status to assist in the swift advance of Ampligen as a potential treatment for this unmet medical need. Fast Track designation would give AIM the opportunity to meet more often with the FDA to quickly advance Ampligen through the different phases of the IND, potentially accelerating approval.

    The benefits of having an orphan-designated medication with commercial approval in the EU include up to ten years of protection from market competition from similar medicines with similar active components, and indication for use that are not shown to be clinically superior.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate," and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Orphan Medicinal Production Designation, while beneficial, does not assure commercial approval. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. No assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. While the company believes that it is adequately funded for current trials over the next two years, no assurance can be given that additional funding will not be required for future studies or the full anticipated IND and CTA processes. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com 

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b061229e-efb9-4a4d-8387-f105edcc08a2



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  25. OCALA, Fla., Feb. 05, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed its At-The-Market (ATM) facility and closed the ATM's Equity Distribution Agreement (EDA). Management believes, based on the company's current financial condition, that it has adequate funds to meet its anticipated operational cash needs and fund current clinical trials over approximately the next twenty-four months.

    "Our robust financial state should allow us to move forward on many important shots on goal, as we advance towards many of our previously stated important inflection points, without the need for a renewed EDA-based ATM facility. While we have an outstanding track record of initiating investigator-sponsored clinical…

    OCALA, Fla., Feb. 05, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed its At-The-Market (ATM) facility and closed the ATM's Equity Distribution Agreement (EDA). Management believes, based on the company's current financial condition, that it has adequate funds to meet its anticipated operational cash needs and fund current clinical trials over approximately the next twenty-four months.

    "Our robust financial state should allow us to move forward on many important shots on goal, as we advance towards many of our previously stated important inflection points, without the need for a renewed EDA-based ATM facility. While we have an outstanding track record of initiating investigator-sponsored clinical trials based on governmental, non-governmental organization (NGO) or industry grants, we now hope to accelerate AIM-sponsored developmental programs in oncology, COVID, ME/CFS and Long COVID, by independently financing activities where situations demand swift action," states AIM CEO Thomas K. Equels. "I believe our clear progress to date in oncology, ME/CFS, COVID and Long COVID signals the shape of things to come in 2021. Our team at AIM will work hard to achieve material forward progress to accomplish our clearly stated objectives."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company's anticipated financial and operational needs are based upon assumptions including, but not limited to, positive results from current studies and that such results will not require additional unanticipated changes to such studies or additional studies. Should some or many of these unanticipated events occur, the Company could very well need additional funding. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  26. OCALA, Fla., Jan. 29, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, a critical step in the company's ongoing efforts to develop Ampligen as a COVID-19 treatment.  

    CHDR, an independent institute located in Leiden in the Netherlands, will conduct and manage the proposed clinical study, titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects."

    Current study plans call…

    OCALA, Fla., Jan. 29, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, a critical step in the company's ongoing efforts to develop Ampligen as a COVID-19 treatment.  

    CHDR, an independent institute located in Leiden in the Netherlands, will conduct and manage the proposed clinical study, titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects."

    Current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and one placebo group, for a total of 40 healthy subjects. They will receive intranasal dosing every other day for 13 days, for a total of seven doses each.

    AIM is funding the clinical study. The company is working to finalize the study protocol and will announce new information as it becomes available.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  27. OCALA, Fla., Jan. 15, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has rescheduled its investor conference call for 11:00 a.m. Eastern Time on Thursday, January 21, 2021 to discuss the recently announced commencement of the treatment of subjects with COVID-19-induced chronic fatigue-like symptoms in the amended AMP-511 trial, recent accomplishments and upcoming milestones.

    Investors and other interested parties are invited to submit questions to management prior to the call's start via email to aim@crescendo-ir.com. Management respectfully requests that questions be non-compound, direct and addressing single subjects.

    The conference call will be available on the Company's website at https://aimimmuno.com/events-presentations/

    OCALA, Fla., Jan. 15, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has rescheduled its investor conference call for 11:00 a.m. Eastern Time on Thursday, January 21, 2021 to discuss the recently announced commencement of the treatment of subjects with COVID-19-induced chronic fatigue-like symptoms in the amended AMP-511 trial, recent accomplishments and upcoming milestones.

    Investors and other interested parties are invited to submit questions to management prior to the call's start via email to aim@crescendo-ir.com. Management respectfully requests that questions be non-compound, direct and addressing single subjects.

    The conference call will be available on the Company's website at https://aimimmuno.com/events-presentations/, or via telephone by dialing toll free 877-407-8031 for U.S. callers, or +1 201-689-8031 for international callers.

    For those unable to participate at that time, a replay of the call will be archived on the Company's website or can be accessed by dialing 877-481-4010 for U.S. callers, or +1 919-882-2331 for international callers and entering the pass code 39447. The replay will be available for 90 days.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc.

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  28. OCALA, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) and its CEO Thomas K. Equels today announced that this week's planned investor conference call will be postponed and rescheduled for a later date following the death of Mr. Equels' mother over this past weekend.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com


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    OCALA, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) and its CEO Thomas K. Equels today announced that this week's planned investor conference call will be postponed and rescheduled for a later date following the death of Mr. Equels' mother over this past weekend.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  29. OCALA, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the active AMP-511 Expanded Access Program (EAP) has dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod), marking a significant milestone in AIM's efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled. The Company also reported it will host an investor conference call on January 12, 2020 at 11AM ET to discuss the AMP-511 trial, believed to be the first clinical trial to treat a patient with COVID-19-induced chronic fatigue-like symptoms, as well as to provide an overall status update…

    OCALA, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the active AMP-511 Expanded Access Program (EAP) has dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod), marking a significant milestone in AIM's efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled. The Company also reported it will host an investor conference call on January 12, 2020 at 11AM ET to discuss the AMP-511 trial, believed to be the first clinical trial to treat a patient with COVID-19-induced chronic fatigue-like symptoms, as well as to provide an overall status update on the Company.

    The Ampligen EAP protocol is authorized at any one time to enroll up to 100 active Chronic Fatigue Syndrome trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nevada.

    "AIM is committed to helping the untold number of people who are already dealing with the long-term effects of COVID-19 infection," said AIM CEO Thomas K. Equels. "The development of an effective therapy for COVID-19-induced chronic fatigue is a critical unmet public health need. SARS-CoV-2 infection-induced chronic fatigue may affect millions in the aftermath of the pandemic. Although AMP-511 is not a controlled trial, patients in this AIM-sponsored study are monitored closely and it may be possible to report important observations as early as May."

    "Hunter-Hopkins Center is excited to have started Ampligen therapy for the first time on a Long Hauler with CFS-like symptoms," said Dr. Lapp. "This is a historic moment. We believe that Long Haulers experience a post-viral fatigue syndrome similar to many persons with Chronic Fatigue Syndrome, and starting treatment early and aggressively should enhance the potential to improve their symptoms and outcomes."

    AIM announced late last year that the Ampligen-involved myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) EAP would be expanded to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – and whose persistence of symptoms has led to the group being dubbed "Long Haulers." Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome. Early treatment may be a key to successful therapy (See: PLOS ONE).

    View a recent U.S. National Institutes of Health workshop on Post-Acute Sequelae of COVID-19.

    "Ampligen is approved in Argentina as the world's first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS," said Equels. "We are highly encouraged by the prospects for Ampligen as a potential therapeutic for this devastating illness, and believe that the AMP-511 clinical trial will help validate Ampligen's potential role in combatting COVID-19-induced chronic fatigue."

    For more information, see discussion of AIM in The Wall Street Journal, "Long-Haul COVID Patients Put Hope in Experimental Drugs."

    Conference Call

    AIM CEO Thomas K. Equels will host a conference call at 11:00 AM Eastern Time Tuesday, January 12, 2020. The conference call will be available on the Company's website at https://aimimmuno.com/events-presentations/, or via telephone by dialing toll free 877-407-8031 for U.S. callers, or +1 201-689-8031 for international callers.

    For those unable to participate at that time, a replay of the call will be archived on the Company's website or can be accessed by dialing 877-481-4010 for U.S. callers, or +1 919-882-2331 for international callers and entering the pass code 39447. The replay will be available for 90 days.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. For example, no assurance can be given that the Ampligen (rintatolimod) EAP protocol described above will yield positive results and additional testing and trials will be required. Trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e293adfc-822c-47d9-a917-9b6b233789d4



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  30. OCALA, Fla., Dec. 24, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announced today that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – but who now demonstrate post-acute infection chronic fatigue-like symptoms. These patients are commonly…

    OCALA, Fla., Dec. 24, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announced today that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – but who now demonstrate post-acute infection chronic fatigue-like symptoms. These patients are commonly referred to as Long Haulers because of the persistence of their post-COVID-19 symptoms.

    Ampligen is AIM's TLR3 agonist immune-system modulator. It is approved in Argentina as the world's first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS.

    The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev.

    Enrollment is an important milestone in AIM's program to develop Ampligen as a therapy for the millions of people who medical experts predict will suffer from SARS-CoV-2-induced chronic fatigue, including many with brain fog. Nearly 70 million COVID-19 cases have been recorded during the ongoing global pandemic. Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome.

    Given the massive pandemic caused by SARS-CoV-2, a virus with almost identical genetic sequence and similar in pathogenesis to the first SARS virus with persuasive emerging evidence supporting COVID-19's SARS-CoV-2 induced chronic fatigue is following a similar pattern. The development of an effective therapy is a critical unmet public health need for patients with acute SARS-CoV-2 infection-induced classic chronic fatigue symptoms. For more information, see AIM featured in The Wall Street Journal, "Long-Haul COVID Patients Put Hope in Experimental Drugs."

    Dr. Lapp states, "It is anticipated that COVID-19 will trigger a large number ‘long haulers' suffering COVID induced brain impairment and disabling fatigue. I believe the investigational immune-modulating antiviral drug Ampligen might have a role to play as a future therapy. I believe the data to date suggests that early treatment will lead to better levels of efficacy."

    Dr. Peterson states: "A hypothesis-based re-analysis of CFS patients treated with Ampligen in a randomized-controlled study showed that CFS patients with shorter duration of CFS symptoms were more than twice as likely to respond to Ampligen than the group as a whole. We are cautiously optimistic that early Ampligen treatment of post-COVID-19 patients with Long Hauler chronic fatigue will have the potential to induce a clinically beneficial outcome. This addition to the study will also allow longitudinal follow-up of clinical disease, as well as contribute to the investigation of pathogenesis and prognosis." (See: PLOS ONE).

    AIM CEO Thomas K. Equels states: "While major global pharmaceutical companies have understandably focused their efforts on developing COVID-19 vaccines, AIM believes there is an equally essential need to help post-COVID-19 patients who, while having recovered from the acute infection, may be suffering from long-term and debilitating COVID-induced chronic fatigue symptoms such as brain fog and disabling and profound post-exertional malaise. We hope that the treatment of ‘Long-Hauler' patients in our AMP-511 clinical trial can help us to quickly determine whether Ampligen has potential as an important therapy for this post-COVID-19 syndrome. If successful, this may change millions of lives for the better."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. For example, no assurance can be given that the Ampligen EAP protocol described above will yield positive results and additional testing and trials will be required. Trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Company personnel were involved in the PLOSONE article referenced above. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    Photos accompanying this announcement are available at:

    https://www.globenewswire.com/NewsRoom/AttachmentNg/34b80e21-269d-47dd-baf9-885e123d042c

    https://www.globenewswire.com/NewsRoom/AttachmentNg/7d09de7a-05e3-4f9d-a77b-922fcd9496c3



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  31. AIM ImmunoTech Announces Availability of the ME/CFS Clinical Trial of its Drug Ampligen for Enrollment to COVID-19 ‘Long Haulers'

    Institutional Review Board Authorizes Public Notification for Potential Enrollment of Subjects

    OCALA, FL / ACCESSWIRE / December 24, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) announced today that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received…

    AIM ImmunoTech Announces Availability of the ME/CFS Clinical Trial of its Drug Ampligen for Enrollment to COVID-19 ‘Long Haulers'

    Institutional Review Board Authorizes Public Notification for Potential Enrollment of Subjects

    OCALA, FL / ACCESSWIRE / December 24, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) announced today that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 - which causes the disease COVID-19 - but who now demonstrate post-acute infection chronic fatigue-like symptoms. These patients are commonly referred to as Long Haulers because of the persistence of their post-COVID-19 symptoms.

    Ampligen is AIM's TLR3 agonist immune-system modulator. It is approved in Argentina as the world's first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS.

    The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev.

    Enrollment is an important milestone in AIM's program to develop Ampligen as a therapy for the millions of people who medical experts predict will suffer from SARS-CoV-2-induced chronic fatigue, including many with brain fog. Nearly 70 million COVID-19 cases have been recorded during the ongoing global pandemic. Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome.

    Given the massive pandemic caused by SARS-CoV-2, a virus with almost identical genetic sequence and similar in pathogenesis to the first SARS virus with persuasive emerging evidence supporting COVID-19's SARS-CoV-2 induced chronic fatigue is following a similar pattern. The development of an effective therapy is a critical unmet public health need for patients with acute SARS-CoV-2 infection-induced classic chronic fatigue symptoms. For more information, see AIM featured in The Wall Street Journal, "Long-Haul COVID Patients Put Hope in Experimental Drugs."

    Dr. Lapp states, "It is anticipated that COVID-19 will trigger a large number ‘long haulers' suffering COVID induced brain impairment and disabling fatigue. I believe the investigational immune-modulating antiviral drug Ampligen might have a role to play as a future therapy. I believe the data to date suggests that early treatment will lead to better levels of efficacy."

    Dr. Charles Lapp, Hunter-Hopkins Center, Charlotte, N.C.

    Dr. Daniel Peterson, Sierra Internal Medicine, Incline Village, Nev.

    Dr. Peterson states: "A hypothesis-based re-analysis of CFS patients treated with Ampligen in a randomized-controlled study showed that CFS patients with shorter duration of CFS symptoms were more than twice as likely to respond to Ampligen than the group as a whole. We are cautiously optimistic that early Ampligen treatment of post-COVID-19 patients with Long Hauler chronic fatigue will have the potential to induce a clinically beneficial outcome. This addition to the study will also allow longitudinal follow-up of clinical disease, as well as contribute to the investigation of pathogenesis and prognosis." (See: PLOS ONE).

    AIM CEO Thomas K. Equels states: "While major global pharmaceutical companies have understandably focused their efforts on developing COVID-19 vaccines, AIM believes there is an equally essential need to help post-COVID-19 patients who, while having recovered from the acute infection, may be suffering from long-term and debilitating COVID-induced chronic fatigue symptoms such as brain fog and disabling and profound post-exertional malaise. We hope that the treatment of ‘Long-Hauler' patients in our AMP-511 clinical trial can help us to quickly determine whether Ampligen has potential as an important therapy for this post-COVID-19 syndrome. If successful, this may change millions of lives for the better."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. For example, no assurance can be given that the Ampligen EAP protocol described above will yield positive results and additional testing and trials will be required. Trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Company personnel were involved in the PLOSONE article referenced above. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc



    View source version on accesswire.com:
    https://www.accesswire.com/622264/AIM-ImmunoTech-Announces-Availability-of-the-MECFS-Clinical-Trial-of-its-Drug-Ampligen-for-Enrollment-to-COVID-19-Long-Haulers

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  32. OCALA, Fla., Dec. 21, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the U.S. Food and Drug Administration on December 17, 2020 granted Orphan Drug Designation status to AIM's drug Ampligen (rintatolimod) for the treatment of pancreatic cancer.

    The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act. The status…

    OCALA, Fla., Dec. 21, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the U.S. Food and Drug Administration on December 17, 2020 granted Orphan Drug Designation status to AIM's drug Ampligen (rintatolimod) for the treatment of pancreatic cancer.

    The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act. The status helps incentivize the treatment of therapies to treat unmet medical needs by providing a company with seven years of exclusivity rights once a drug reaches market.

    Pancreatic cancer is the fourth leading cause of cancer deaths in the United States and the only cancer, among those most commonly diagnosed, with a five-year survival rate at just six percent, according to the Pancreatic Cancer Action Network.

    AIM recently announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program conducted at Erasmus University Medical Center in the Netherlands. The median overall survival was approximately two-fold higher – that is 200% – in the Ampligen arm, as compared to a historical control cohort matched for age, gender, stage of disease and number of cycles of Folfirinox therapy.

    "This study data demonstrates that Ampligen has the potential to extend the survival rates of people suffering with pancreatic cancer significantly when compared to the traditional standard of care for this deadly disease," said AIM CEO Thomas K. Equels.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate," and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. There is no assurance that the European Medicines Agency will grant an orphan drug designation. In addition, no assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a599fad2-ff32-43f6-bf01-a5728af0f680



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  33. OCALA, Fla., Nov. 25, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced developments in its work to develop new treatments or preventive strategies for COVID-19, the disease caused by SARS-CoV-2.

    First, AIM reports that Roswell Park Comprehensive Cancer Center's Phase 1/2a study evaluating the two-drug combination of AIM's Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study.

    AIM is a collaborator on that clinical trial, which is funded in part through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park. AIM is providing…

    OCALA, Fla., Nov. 25, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced developments in its work to develop new treatments or preventive strategies for COVID-19, the disease caused by SARS-CoV-2.

    First, AIM reports that Roswell Park Comprehensive Cancer Center's Phase 1/2a study evaluating the two-drug combination of AIM's Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study.

    AIM is a collaborator on that clinical trial, which is funded in part through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park. AIM is providing Ampligen at no charge for this study. Full details about this trial, which is led by Roswell Park co-Principal Investigators, Drs. Brahm Segal and Pawel Kalinski, are available at ClinicalTrials.gov.

    Additionally, the AIM team is working to develop:

    • An intranasal prophylaxis strategy for frontline workers, the elderly and other high-risk patients, including those with co-morbidities such as cancer; and



    • An effective therapy for COVID-19 Long Haulers, so named due to the persistence of their symptoms after their infections have ended.

    According to AIM CEO Thomas K. Equels: "While major global pharmaceutical companies have largely focused their efforts on the critical need for a COVID-19 vaccine – with Moderna and Pfizer recently announcing significant and hopeful results – AIM believes there is an equally critical health need to develop an early-onset treatment for people already infected with the disease. We greatly appreciate the leadership of Dr. Brahm Segal and Dr. Pawel Kalinski, as well as the tremendous efforts of the entire team at Roswell Park. We look forward to providing further updates as this critical trial progresses."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. Any forward-looking statements set forth in this press release speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. For instance, no assurance can be given as to whether the above mentioned study will prove successful. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if such clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that the Company's actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make its efforts ultimately unproductive. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com



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  34. OCALA, Fla., Nov. 13, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided a business update for the third quarter ended September 30, 2020.

    Third Quarter 2020 Financial Highlights:

    • As of September 30, 2020, AIM had cash, cash equivalents and marketable securities of $54.5 million, as compared to $8.8 million as of December 31, 2019.
    • Research and development expenses for the three months ended September 30, 2020 were $1.10 million, compared to $1.19 million for the three months ended September 30, 2019.
    • General and administrative expenses for the three months ended…

    OCALA, Fla., Nov. 13, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided a business update for the third quarter ended September 30, 2020.

    Third Quarter 2020 Financial Highlights:

    • As of September 30, 2020, AIM had cash, cash equivalents and marketable securities of $54.5 million, as compared to $8.8 million as of December 31, 2019.
    • Research and development expenses for the three months ended September 30, 2020 were $1.10 million, compared to $1.19 million for the three months ended September 30, 2019.
    • General and administrative expenses for the three months ended September 30, 2020 were $2.09 million, compared to $1.85 million for the three months ended September 30, 2019.

    The Company's complete financial results are available in the Company's September 30, 2020 Form 10-Q filed with the Securities and Exchange Commission on November 12, 2020, which is available at www.sec.gov and on the Company's website.

    Recent Clinical and Business Highlights

    AIM has announced several significant clinical, research and business milestones since the start of the third quarter of 2020.

    Immuno-oncology

    On September 22, AIM announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program conducted at Erasmus University Medical Center in the Netherlands. Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using AIM's drug Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls. A detailed clinical report and an article for publication are being prepared by the Erasmus MC team. AIM intends to facilitate a follow-up pancreatic cancer Phase 2/3 clinical trial based on these data.

    Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and COVID-19

    On November 2, AIM announced the publication of statistically significant ME/CFS findings providing further support for the considerable positive impact Ampligen may have on people living with ME/CFS when administered in the early stages of the disease. The data were published in PLOS ONE. AIM researchers found, in a reanalysis of data from the earlier Phase 3 study, that the TLR3 agonist Ampligen substantially improved physical performance in a subset of early-onset ME/CFS patients. The findings potentially carry special importance for survivors of COVID-19, many of whom report classic chronic fatigue-like symptoms after recovering from the acute SARS-CoV-2 infection. These patients — who are commonly referred to as "Long Haulers" because of the persistence of these symptoms — are uniquely situated to potentially benefit from Ampligen as an early onset therapy. As part of its plan to study this potential benefit, on October 6, AIM announced the receipt of Institutional Review Board approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2.

    COVID-19

    On August 27, AIM announced the identification of an effective in vitro model in which Ampligen was shown to be able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal dosage levels. This demonstration of Ampligen's bioactivity against SARS-CoV-2 supports the company's commitment to the development of Ampligen as both a prophylaxis and early onset intranasal therapy for COVID-19. To that end, on September 16, AIM announced that recruitment had begun in Roswell Park Comprehensive Cancer Center's Phase 1/2a COVID-19 clinical study of the effectiveness of Ampligen in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. This followed the Clinical Trial Agreement between AIM and Roswell Park announced on July 9. Less than a week earlier, on July 6, AIM also announced its entry into a trilateral Material Transfer and Research Agreement with Japan's National Institute of Infectious Diseases and Shionogi & Co., Ltd. to test Ampligen as a potential vaccine adjuvant for COVID-19. Under the agreement, AIM will provide Ampligen samples for various research projects.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that the Company's actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. The Company recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

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  35. OCALA, Fla., Nov. 02, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announced today the publication of statistically significant data detailing how its drug Ampligen could have a considerable positive impact on people living with the debilitating illness myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) when administered in the early stages of the disease. The data were published in PLOS ONE, a peer-reviewed open access scientific journal published by the Public Library of Science.

    AIM researchers found that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients. Analysis of Exercise Treadmill Testing (ETT) data from its Phase III trial has identified a subset of patients with…

    OCALA, Fla., Nov. 02, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announced today the publication of statistically significant data detailing how its drug Ampligen could have a considerable positive impact on people living with the debilitating illness myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) when administered in the early stages of the disease. The data were published in PLOS ONE, a peer-reviewed open access scientific journal published by the Public Library of Science.

    AIM researchers found that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients. Analysis of Exercise Treadmill Testing (ETT) data from its Phase III trial has identified a subset of patients with at least a two-fold increased exercise response to Ampligen.

    Study Analysis

    The ME/CFS population of 208 subjects was divided into two subsets based on symptom duration. The Target subset consisting of 75 patients with ME/CFS symptom duration of 2-8 years was compared to a Non-Target subset consisting of 133 patients with symptom duration outside of the 2-8-year range. Researchers identified 2-8 years as the preferred Target subset for the data analysis in an attempt to reduce possible cases of spontaneous remission after disease onset, while still including several years for ME/CFS symptoms to persist.

    The placebo-adjusted percentage increase in ETT and the vertical rise in feet while exercising on the treadmill in the Target subset were both at least twice that seen for the combined population of 208 subjects. While no clinically significant ETT response was seen in the Non-Target subset, within the Target subset, 51.2% of the Ampligen-treated subjects improved their exercise duration by at least 25% (p=0.003, a statistically significant value). This magnitude of exercise improvement was associated with additional measures of improved quality of life, including an ability to ascend the equivalent of nearly 175 more vertical feet at Week 40 when compared to the baseline value before the Ampligen treatment was started. The analysis indicates that there may be a relatively short disease duration window early in the course of the disease (before eight years) in which ME/CFS patients may see a significant clinical response.

    Many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors met the CDC criteria for chronic fatigue syndrome, which requires at least 6 months of symptoms (See: jamanetwork.com/fullarticle/415378). There is now increasing evidence that patients with COVID-19 — the disease caused by SARS-CoV-2 — can develop a similar, ME/CFS-like illness, which aligns with anecdotal accounts of ME/CFS symptoms commencing after flu-like syndromes (See: https://jamanetwork.com/fullarticle/2768351). 

    The findings in the PLOS ONE publication potentially carry special importance for survivors of COVID-19, many of whom report classic chronic fatigue-like symptoms long after recovering from the acute SARS-CoV-2 infection. These patients are commonly referred to as "Long Haulers" because of the persistence of these symptoms. They are also uniquely situated to potentially benefit from Ampligen as an early onset therapy for subjects who have recovered from acute COVID-19 only to come down with chronic fatigue-like symptoms.

    AIM announced on October 6 the receipt of Institutional Review Board (IRB) approval to expand its AMP-511 Early Access Program for ME/CFS patients to also include Long Haulers in the clinical sites at Incline Village, Nev. at Lake Tahoe and Charlotte, N.C. The expansion is designed to test the hypothesis that if Ampligen is to have beneficial effects on Long Haulers, then it would likely need to be used earlier in the disease process rather than later. AIM filed a provisional patent application for the use of Ampligen for COVID-19-induced chronic fatigue in June of 2020 (See: AIM ImmunoTech PR June 11, 2020).

    "More than 10 percent of persons who contract COVID-19 develop long term symptoms that are remarkably similar to persons with Chronic Fatigue Syndrome (also known as ME/CFS). So there may be thousands of individuals with CFS-like illness in the near future. Such ‘Long Haulers' could prove to benefit from Ampligen therapy. Moreover, the recently released analyses published in PLOS ONE indicate that the potential benefit of Ampligen in patients with ME/CFS may depend on treatment earlier in the disease," said Charles Lapp, MD, of the Hunter-Hopkins Center, PLLC. (See: https://jamanetwork.com/fullarticle/2768351)

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. For example, the FDA could require changes to the IRB approved trial protocol amendment and testing will be required to determine whether or not Ampligen will assist in the treatment of COVID-19 induced CFS-like cases. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. No assurance can be given as to whether current, planned or other clinical trials necessary to potential FDA approval will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. The study was designed and conducted by AIM.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    Source: AIM ImmunoTech Inc.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1d4ca343-93dc-4e28-bae1-8f004af28bf0

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  36. TAMPA, Fla. and OCALA, Fla., Oct. 30, 2020 (GLOBE NEWSWIRE) -- BioFlorida has announced Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech Inc. (NYSE:AIM), as its Weaver H. Gaines Entrepreneur of the Year. The Entrepreneur of the Year Award recognizes an entrepreneur who has made extraordinary contributions to the growth of life sciences in the leadership of a company or institution. BioFlorida represents 6,700 establishments and research organizations in the biopharmaceuticals, medical technology, healthIT and bioagriculture sectors.

    Thomas K. Equels is the CEO of AIM ImmunoTech Inc., an Ocala, Fla.-based immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders…

    TAMPA, Fla. and OCALA, Fla., Oct. 30, 2020 (GLOBE NEWSWIRE) -- BioFlorida has announced Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech Inc. (NYSE:AIM), as its Weaver H. Gaines Entrepreneur of the Year. The Entrepreneur of the Year Award recognizes an entrepreneur who has made extraordinary contributions to the growth of life sciences in the leadership of a company or institution. BioFlorida represents 6,700 establishments and research organizations in the biopharmaceuticals, medical technology, healthIT and bioagriculture sectors.

    Thomas K. Equels is the CEO of AIM ImmunoTech Inc., an Ocala, Fla.-based immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus. Equels' successful legal career included extensive experience in the pharma sector. He has over the years served as a court-appointed receiver turning around businesses in a number of different fields. Equels received his J.D. with high honors from Florida State University. He is also a summa cum laude graduate (Bachelor of Science) of Troy University and obtained his Master of Science Degree from Troy. He also received Troy's "Scholarship Award" as one of two graduates with a perfect GPA. Equels is also a highly decorated combat aviator, twice awarded the Distinguished Flying Cross, and awarded the Purple Heart, the Bronze Star and 15 Air Medals, including three for extraordinary valor. In 2012, he was knighted by Pope Benedict as a knight of the Papal States.

    "We are pleased to present Thomas K. Equels with this award for his contributions to the Florida life sciences industry and his ongoing passion and commitment to find solutions for the treatment of seriously debilitating disorders — including their work to fight COVID-19," said Nancy K. Bryan, President and CEO of BioFlorida.

    "Tom Equels is a deserving recipient of BioFlorida's ‘Entrepreneur of the Year' award. Tom left a highly successful legal practice in 2016 to assume the leadership role at AIM. In less than four years he has positioned Ampligen — its principal lead drug — in a large number of promising clinical trials, as well as established financial stability at AIM. Tom's progress in proving the enormous potential of Ampligen has been remarkable," said William Mitchell, MD, Chairman of the Board of Directors of AIM.

    AIM's flagship products are Ampligen (rintatolimod) and Alferon N Injection. Ampligen is being evaluated as a potential therapeutic for COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), for multiple types of cancers and as a viral vaccine adjuvant. Alferon is a natural interferon that is approved in the U.S. and Argentina.

    In a potential breakthrough, Ampligen has demonstrated the potential for standalone efficacy in the clinical setting in pancreatic cancer. In this regard, AIM recently announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program conducted at Erasmus University Medical Center in the Netherlands.

    Safety and efficacy of Ampligen is also being studied in several immuno-oncology clinical trials at highly respected NCI-Designated Cancer Centers; two of which are in combination with the checkpoint blockade drug pembrolizumab. The National Cancer Institute has awarded $14.5 million to Roswell Park to fund five immuno-oncology clinical trials. In addition, two Dept. of Defense "Breakthrough Awards" totaling approximately $15 million to Roswell Park Comprehensive Cancer Center and Moffitt Cancer Center for Ampligen studies are expected to commence in 2020-21 in brain-metastatic breast cancer.

    AIM recently signed a clinical trial agreement with Roswell Park Comprehensive Cancer Center supporting an FDA-authorized Phase 1/2 clinical trial of Ampligen combined with Interferon Alfa-2b (clinicaltrials.gov/NCT04379518) to test the safety and effectiveness of the combination regimen to clear the SARS-CoV-2 virus from the upper airway in patients with cancer and mild-to-moderate COVID-19. AIM also recently signed a material transfer and research agreement with Japan's National Institute of Infectious Diseases and Shionogi, a leading global pharmaceutical company, to test Ampligen as a potential vaccine adjuvant for COVID-19. The pre-clinical testing and research is being conducted by their laboratories in Japan.

    About BioFlorida

    BioFlorida is the voice of Florida's life science industry, representing 6,700 establishments and research organizations in the biopharmaceutical, medical technology, and bioagriculture sectors that collectively employ 87,000 Floridians. [Source: The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life (TEConomy/BIO, 2016)] BioFlorida's member driven initiatives provide a strong business climate for the advancement of innovative products and technology that improve lives and promote economic benefits to the state. Link to their website

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus. For more information on AIM ImmunoTech, please visit www.aimimmuno.com.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 or COVID-19-induced CFS-like cases or immuno-oncology in humans and no assurance can be given that it will be the case. Additionally, no assurance can be given as to whether the current or planned trials will be initiated and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, a change in priorities at the institutions sponsoring other trials or will require additional funding. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful, or yield any useful data or require additional funding. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced.

    BioFlorida Contact:

    Courtney Cox, PR Counsel

    (850) 559-0708

    CourtneyC@TheMooreAgency.com

    AIM Contact:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b36f596a-c136-491f-b1bc-c45c02f778d9

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  37. OCALA, Fla. , Oct. 22, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, is scheduled to participate in a virtual panel titled, "COVID-19: Progress on Treatments & Prevention" on Thursday, October 29, at 10:05 A.M. Eastern Time at the 23rd Annual BioFlorida Conference. The presentation will be webcast live on the conference event platform, which can be accessed here.

    The BioFlorida Conference 2020 will feature global experts in keynote and breakout sessions addressing the latest trends in BioPharma, MedTech, HealthIT and COVID-19. Informative programs will cover current science advancements, business and public policy, as well as showcase Florida's achievements…

    OCALA, Fla. , Oct. 22, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, is scheduled to participate in a virtual panel titled, "COVID-19: Progress on Treatments & Prevention" on Thursday, October 29, at 10:05 A.M. Eastern Time at the 23rd Annual BioFlorida Conference. The presentation will be webcast live on the conference event platform, which can be accessed here.

    The BioFlorida Conference 2020 will feature global experts in keynote and breakout sessions addressing the latest trends in BioPharma, MedTech, HealthIT and COVID-19. Informative programs will cover current science advancements, business and public policy, as well as showcase Florida's achievements and innovation.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus. For more information on AIM ImmunoTech, please visit www.aimimmuno.com.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

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  38. OCALA, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) is pleased to announce that it has received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with AIM's flagship pipeline drug Ampligen.

    These patients — commonly referred to as Post-COVID-19 Chronic Fatigue (PCCF) / "Long Haulers" because of the persistence of their symptoms — will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. Up to 20 of the 100 active…

    OCALA, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) is pleased to announce that it has received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with AIM's flagship pipeline drug Ampligen.

    These patients — commonly referred to as Post-COVID-19 Chronic Fatigue (PCCF) / "Long Haulers" because of the persistence of their symptoms — will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. Up to 20 of the 100 active participants can be Long Haulers, according to the new trial protocol amendment. AIM is currently preparing the IRB-approved protocol for submission to the U.S. Food and Drug Administration ("FDA").

    "It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS," according to Charles Lapp, MD, a global expert in ME/CFS. "The investigational immune-modulating antiviral drug Ampligen might have a role to play in this scenario."

    Many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors met the CDC criteria for chronic fatigue syndrome (See: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/415378). There is now increasing evidence that patients with COVID-19 — the disease caused by SARS-CoV-2 — can develop a similar, ME/CFS-like illness (See: https://jamanetwork.com/journals/jama/fullarticle/2768351). AIM CEO Thomas K. Equels states, "With millions of U.S. cases of COVID-19 already on record we can expect a tidal wave of new U.S. cases of COVID-19 sufferers who will exhibit serious chronic fatigue-like symptoms. In addition, unpublished data from AIM indicates that ME/CFS patients respond better to Ampligen the earlier they receive the drug, so enrolling ‘Long Haulers' earlier in their diagnosis could potentially benefit these patients while also providing valuable information for all ME/CFS patients."

    In June, AIM filed a provisional utility patent application for Ampligen as a potential therapy for COVID-19-induced ME/CFS-like illness (See: https://aimimmuno.irpass.com/AIM-ImmunoTech-Files-Provisional-Patent-Application-for-the-Use-of-AmpligenR-as-a-Potential-Therapy-for-COVID-19-Induced-Chronic-Fatigue).

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. For example, the FDA could require changes to the trial protocol amendment and testing will be required to determine whether or not Ampligen will assist in the treatment of COVID-19 induced CFS-like cases. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

    Source: AIM ImmunoTech Inc.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/53029413-d7ab-421c-b47d-37c7fa39df48

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  39. Median survival approximately two-fold higher in Ampligen arm compared to historical controls; AIM to seek FDA Fast Track designation and orphan drug status in late stage pancreatic cancer

    OCALA, FL / ACCESSWIRE / September 22, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus University Medical Center in the Netherlands.

    Prof. Casper van Eijck, MD, PhD, oncologist and a global leading expert in pancreatic cancer

    Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic…

    Median survival approximately two-fold higher in Ampligen arm compared to historical controls; AIM to seek FDA Fast Track designation and orphan drug status in late stage pancreatic cancer

    OCALA, FL / ACCESSWIRE / September 22, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus University Medical Center in the Netherlands.

    Prof. Casper van Eijck, MD, PhD, oncologist and a global leading expert in pancreatic cancer

    Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Prof. van Eijck states, "The overall survival of the experimental group was compared to a large historical control cohort matched for age, gender, stage of disease, and number of cycles of Folfirinox chemotherapy. Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls. These results were obtained with a very high degree of statistical significance. Based on these data, I see the potential for Ampligen as a meaningful extension of the standard of care for advanced pancreatic cancer, which we are planning to investigate further." A detailed clinical report and an article for publication are being prepared by Prof. van Eijck and his team at Erasmus MC.

    AIM CEO Thomas K. Equels states: "We started this program in January 2017. These exceptional results from Erasmus exceed even our most optimistic expectations. I am deeply grateful to Prof. Casper van Eijck, his team at Erasmus, and Ronald Brus, MD, the guiding hand at myTomorrows, for their vision and careful diligence in implementing this important analysis of Ampligen as a single-agent therapy for late-stage pancreatic cancer. I extend deep gratitude to the government of the Netherlands for its pioneering support and commitment to advancing a critical medical innovation in a deadly cancer with very limited medical interventions. Medical advances in lethal unmet medical needs depend on this sort of outstanding clinical and governmental cooperation and support. We could not have accomplished this but for the support of the Netherlands."

    AIM will work with its Contract Research Organization, Amarex Clinical Research LLC, to seek FDA "fast-track" and possibly even FDA "breakthrough" designations and to obtain IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof. van Eijck, and also at major cancer research centers in the United States. AIM also plans to file dual orphan drug status applications for use of Ampligen in the treatment of late-stage pancreatic carcinoma with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). If granted, this serves to extend a company's exclusivity rights once a drug reaches market.

    About AIM ImmunoTech Inc.
    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Cautionary Statement
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate," and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. Initiation of future clinical trials may not occur secondary to many factors, including lack of regulatory approval(s) or lack of study drug. Further, there is no assurance that the FDA or EMA will grant an orphan drug designation. In addition, no assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

    CONTACT:
    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
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  40. OCALA, FL / ACCESSWIRE / September 16, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced that recruitment has begun in Roswell Park Comprehensive Cancer Center's Phase 1/2a clinical study of the effectiveness of rintatolimod (Ampligen) in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19 infection, which is caused by the SARS-CoV-2 virus.

    Roswell Park has reported through the national clinical-trials database ClinicalTrials.gov that recruitment is underway for the study, which is led by two senior leaders at the Buffalo, N.Y., cancer center: Brahm Segal, MD, and Pawel Kalinski, MD, PhD.

    The study team describes their approach this way, as reported at ClinicalTrials.gov: "Interferon alpha is a protein…

    OCALA, FL / ACCESSWIRE / September 16, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced that recruitment has begun in Roswell Park Comprehensive Cancer Center's Phase 1/2a clinical study of the effectiveness of rintatolimod (Ampligen) in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19 infection, which is caused by the SARS-CoV-2 virus.

    Roswell Park has reported through the national clinical-trials database ClinicalTrials.gov that recruitment is underway for the study, which is led by two senior leaders at the Buffalo, N.Y., cancer center: Brahm Segal, MD, and Pawel Kalinski, MD, PhD.

    The study team describes their approach this way, as reported at ClinicalTrials.gov: "Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus."

    Approximately 6.4 million people in the United States have been infected with COVID-19 and more than 190,000 have died.

    "This trial reflects our ability to apply unique insights developed over the course of 20 years of work in cancer immunotherapy toward new strategies of engaging the innate immune system against virally mediated diseases," said Dr. Kalinski, scientific lead on the study and principal architect of this strategy as a treatment for both cancer and COVID-19. "Although this trial focuses on the treatment of patients infected with SARS-CoV-2, it is our hope that our findings may also have relevance for treatment of other RNA viruses, including such common pathogens as influenza, HIV and several oncogenic viruses."

    "Reducing replication of the virus may lead to less severe illness among patients at high risk for COVID-19 complications," added Dr. Segal, who is Chair of Internal Medicine and Chief of Infectious Diseases at Roswell Park, and clinical lead on this study.

    Funding for the Roswell Park clinical trial is provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.

    For more information about this study, including eligibility criteria, please contact Roswell Park by phone at 1-800-ROSWELL (1-800-767-9355) or by e-mail to askroswell@Roswellpark.org.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/606236/AIM-ImmunoTech-Highlights-Start-of-Recruitment-in-Roswell-Park-Clinical-Trial-Incorporating-Ampligen-in-the-Treatment-of-Cancer-Patients-with-Mild-or-Moderate-COVID-19

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  41. OCALA, FL / ACCESSWIRE / September 10, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced that the company will be presenting at the H.C. Wainwright Annual Global Investment Conference, being held virtually on September 14-16, 2020.

    Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, is scheduled to present on Monday, September 14 at 5:00 p.m., Eastern Time. The presentation will be webcast live on the conference event platform, which can be accessed here.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo…

    OCALA, FL / ACCESSWIRE / September 10, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced that the company will be presenting at the H.C. Wainwright Annual Global Investment Conference, being held virtually on September 14-16, 2020.

    Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, is scheduled to present on Monday, September 14 at 5:00 p.m., Eastern Time. The presentation will be webcast live on the conference event platform, which can be accessed here.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/605463/AIM-ImmunoTech-to-Present-at-the-HC-Wainwright-22nd-Annual-Global-Investment-Conference-on-September-14th

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  42. VICTORIA, BC, Sept. 8, 2020 /CNW/ - IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSXV:IPA) (OTCQB:IPATF) (FSE:TQB2), a leader in full-service, therapeutic antibody discovery and development, today announced that Dr. Jennifer Bath, CEO of IPA, will participate on a virtual panel, entitled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Tom Equels, CEO of AIM ImmunoTech Inc. (NYSE:AIM); Dr. David Jin, CEO of Avalon GlobloCare Corp. (NASDAQ:AVCO); Jeff Wolf, CEO of Heat Biologics, Inc. (NASDAQ:HTBX) and Vered Caplan, CEO of Orgenesis Inc. (NASDAQ:ORGS).

    The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the COVID-19 pandemic. The panel will be moderated by broadcast journalist Christine Corrado of Proactive Investors. Investors interested in attending the event can register at: 

    https://zoom.us/webinar/register/8215990551540/WN_YFe8n6dQSm6mpgG3iWfF-w

    About ImmunoPrecise Antibodies Ltd.

    ImmunoPrecise is a global technology platform company with end-to-end solutions empowering companies to discover and develop therapies against any disease. The Company's experience and cutting-edge technologies enable unparalleled support of its partners in their quest to bring innovative treatments to the clinic. ImmunoPrecise's full-service capabilities dramatically reduce the time required for, and the inherent risk associated with, conventional multi-vendor product development. For further information, visit www.immunoprecise.com or contact solutions@immunoprecise.com.

    Forward Looking Information

    This news release contains statements that, to the extent they are not recitations of historical fact, may constitute "forward-looking statements" within the meaning of applicable Canadian securities laws. The Company uses words such as "may", "would", "could", "will", "likely", "expect", "believe", "intend", "should" and similar expressions to identify forward-looking statements and include the Company's beliefs with respect to the potential for its antibodies to be further developed or approved to treat COVID-19 (or SARS-CoV-2) or to complete any transactions with respect to those antibodies. Any such forward-looking statements are based on assumptions and analyses made by ImmunoPrecise in light of its experience and its perception of historical trends, current conditions and expected future developments. However, whether actual results and developments will conform to ImmunoPrecise's expectations and predictions is subject to any number of risks, assumptions and uncertainties. Many factors could cause ImmunoPrecise's actual results to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors include, among other things, actual revenues and earnings for IPA being lower than anticipated, and those risks and uncertainties described in ImmunoPrecise's annual management discussion and analysis for the previous quarter ended January 31, 2020 which can be accessed at www.sedar.com. The "forward-looking statements" contained herein speak only as of the date of this press release and, unless required by applicable law, ImmunoPrecise undertakes no obligation to publicly update or revise such information, whether as a result of new information, future events or otherwise.

    Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    SOURCE ImmunoPrecise Antibodies Ltd.

    Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2020/08/c1782.html

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  43. OCALA, FL / ACCESSWIRE / September 8, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), today announced that Thomas K. Equels, CEO of AIM ImmunoTech, will participate in a virtual panel titled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Dr. David Jin, President and CEO of Avalon Globlocare Corp. (NASDAQ:AVCO); Jeff Wolf, CEO of Heat Biologics, Inc. (NASDAQ:HTBX); Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies Ltd. (TSXV:IPA) (OTCQB:IPATF) (FSE:TQB2); and Vered Caplan, CEO of Orgenesis Inc. (NASDAQ:ORGS).

    The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the…

    OCALA, FL / ACCESSWIRE / September 8, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), today announced that Thomas K. Equels, CEO of AIM ImmunoTech, will participate in a virtual panel titled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Dr. David Jin, President and CEO of Avalon Globlocare Corp. (NASDAQ:AVCO); Jeff Wolf, CEO of Heat Biologics, Inc. (NASDAQ:HTBX); Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies Ltd. (TSXV:IPA) (OTCQB:IPATF) (FSE:TQB2); and Vered Caplan, CEO of Orgenesis Inc. (NASDAQ:ORGS).

    The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the COVID-19 pandemic. The panel will be moderated by broadcast journalist Christine Corrado of Proactive Investors. Investors interested in attending the event can register at: https://zoom.us/webinar/register/8215990551540/WN_YFe8n6dQSm6mpgG3iWfF-w.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/604807/AIM-ImmunoTech-CEO-to-Participate-in-Virtual-Panel-New-Approaches-to-COVID-19-Hidden-Breakthroughs-on-Thursday-September-10th

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  44. OCALA, FL / ACCESSWIRE / August 27, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) is pleased to announce that it has identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, a dsRNA TLR3 agonist, and the results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels. This result supports AIM's goal of developing an intranasal prophylactic approach using Ampligen to prevent COVID-19.

    "We are pleased with these results, as they establish Ampligen's bio-activity against SARS-CoV-2 as well as support our decision to test Ampligen in humans as an intranasal prophylaxis and early-onset therapy against COVID-19…

    OCALA, FL / ACCESSWIRE / August 27, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) is pleased to announce that it has identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, a dsRNA TLR3 agonist, and the results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels. This result supports AIM's goal of developing an intranasal prophylactic approach using Ampligen to prevent COVID-19.

    "We are pleased with these results, as they establish Ampligen's bio-activity against SARS-CoV-2 as well as support our decision to test Ampligen in humans as an intranasal prophylaxis and early-onset therapy against COVID-19," said AIM CEO Thomas K. Equels.

    The 3D-mucociliary tissue culture of normal, human-derived tracheal/bronchial epithelial cells sufficiently models some of the key innate immune responses needed to demonstrate Ampligen's prophylactic effect on SARS-CoV-2, the virus that causes COVID-19. The 90% effective concentration (EC90) of Ampligen observed in this tissue culture model is clinically achievable in human subjects to presumptively decrease SARS-CoV-2. Currently, there is a lack of an adequate animal model and therefore the company utilized the USA-WA1/2020 strain of SARS-CoV-2 in a 3-D, in vitro model of normal, human-derived tracheal/bronchial epithelial cells. The results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels. This result supports AIM's goal of developing an intranasal prophylactic approach using Ampligen to prevent COVID-19.

    Ampligen is believed to be a powerful positive modulator of human innate immunity and therefore the best measure of efficacy will be obtained in animal and human experimentation utilizing a living, in vivo, innate immune system.

    In a brief recap of AIM's experimental history in SARS-like diseases, Ampligen has demonstrated clear activity in prior SARS-CoV-1 virus animal experiments. With a SARS-CoV-1 virus mouse model, Ampligen demonstrated 100% protective survival benefit compared to 100% mortality in a saline control group. Ampligen also reduced SARS-CoV-1 lung titers to below the level of detection (Day 2009 and Barnard 2006). However, because similar animal models with mice designed to replicate the human response to SARS-CoV-2 are not yet readily available for experimentation, AIM sought an in vitro experimental model. However, as previously disclosed, the typical cell line for viral experimentation, cloned AGM cells, have lost the genetic capacity to allow Ampligen's biomechanics to be expressed. This general effect was first observed and reported in 2006 in Table 1 of the Barnard, et al. publication in Antiviral Chemistry and Chemotherapy 2006, 17:275. See also, (https://dd7pmep5szm19.cloudfront.net/2265/0001493152-20-011683.htm)

    In 2006, recognizing this defect in the in vitro model, Barnard, et al. then used an in vivo mouse model and Ampligen showed high antiviral activity with reduction in lung titers of SARS-CoV-1 to below the level of detection. Then, in a 2009 follow-up animal experiment, Ampligen demonstrated 100% protective survival as compared to 100% mortality in the control group of rodents.

    For these reasons, while awaiting the availability of future in vivo animal experimental data and human clinical data, AIM pursued this more relevant in vitro model to demonstrate Ampligen's positive bioactivity against the virus that causes COVID-19 using a model consisting of normal, human-derived tracheal/bronchial epithelial (TBE) cells which have been cultured to form a multi-layered, highly differentiated model that closely resembles the epithelial tissue of the respiratory tract. These cells still retained both toll-like receptors as well as the ability to produce and react to interferons induced by Ampligen.

    This demonstration of Ampligen's bioactivity against SARS-CoV-2, resulting in a significant in vitro reduction of infectious virus at clinically achievable doses confirms our commitment for the development of Ampligen as both a prophylaxis and early onset intranasal therapy for COVID-19.

    About AIM ImmunoTech Inc.
    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models and in vitro testing do not necessarily predict results in humans or ultimate FDA approval. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. We recognize that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

    CONTACT:
    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
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  45. Phase 1/2a trial of Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19 is on track for enrollment

    OCALA, FL / ACCESSWIRE / August 17, 2020 / AIM ImmunoTech (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided a business and pre-clinical/clinical update for the second quarter ended June 30, 2020.

    Second Quarter 2020 Financial Highlights:

    • As of June 30, 2020, AIM had cash, cash equivalents and marketable securities of $40.3 million, as compared to $8.8 million as of December 31, 2019.
    • Research and development expenses for the second quarter ended June 30, 2020 were $1.46 million, compared to…

    Phase 1/2a trial of Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19 is on track for enrollment

    OCALA, FL / ACCESSWIRE / August 17, 2020 / AIM ImmunoTech (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided a business and pre-clinical/clinical update for the second quarter ended June 30, 2020.

    Second Quarter 2020 Financial Highlights:

    • As of June 30, 2020, AIM had cash, cash equivalents and marketable securities of $40.3 million, as compared to $8.8 million as of December 31, 2019.
    • Research and development expenses for the second quarter ended June 30, 2020 were $1.46 million, compared to $1.10 million for the second quarter ended June 30, 2019.
    • General and administrative expenses for the second quarter ended June 30, 2020 were $1.72 million, compared to $1.94 million for the second quarter ended June 30, 2019.

    The Company's complete financial results are available in the Company's June 30, 2020 Form 10-Q filed with the Securities and Exchange Commission on August 14, 2020, which is available at www.sec.gov and on the Company's website.

    "AIM is engaged in extremely important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs such as COVID-19 and cancer-providing us ‘multiple shots on goal' within large addressable markets. Given these multiple indications, AIM's strategy to support these trials has been to maximize third-party, non-dilutive funding directly awarded to the clinical sites, which we have accomplished in many of our trials. In addition, we had more than $40 million in cash, cash equivalents, and marketable securities on our balance sheet as of June 30, 2020. As a result, we believe we are extremely well positioned to execute on our strategy going forward, which, in turn, we expect will drive significant value for stockholders," said AIM CEO Thomas K. Equels.

    COVID-19 General Updates:

    • Following the FDA's authorization of an IND on May 11, 2020, AIM entered into a clinical trial agreement on July 6, 2020, with Roswell Park Comprehensive Cancer Center to support Roswell Park's Phase 1/2a trial of Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19, the disease caused by SARS-CoV-2. The trial is on track to commence patient enrollment soon.
    • AIM signed a trilateral material transfer and research agreement with Japan's National Institute of Infectious Diseases and Shionogi & Co., Ltd., a leading global pharmaceutical company headquartered in Japan, in order to test Ampligen as a potential vaccine adjuvant for COVID-19. Ampligen has been shipped to Japan, to be followed up with an additional shipment.
    • AIM is currently collaborating with Shenzhen Smoore, the world's largest vaping device manufacturer, to research the use of their innovative inhalation technology for enhaced delivery of Ampligen deep into the lungs at the first signs of COVID-19. The Company believes this approach may initiate a robust, therapeutic TLR3 response against the SARS-CoV-2 virus throughout the upper and lower respiratory system. Ampligen is scheduled to be shipped to Smoore for testing, pending resolution of various China import regulatory requirements.
    • Ampligen has been shipped to Utah State University to support the University's Institute for Viral Research in its pre-clinical testing againast SARS-CoV-2 and testing is underway.

    COVID-19-induced Chronic Fatigue-like Illness Update:

    • Ampligen has proven to be a powerful drug conferring protective survival in SARS-CoV-1 animal experiments. Ampligen has also shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome (CFS) patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the first drug approved for severe CFS in the world. AIM is preparing to test Ampligen as a potential therapy for a SARS-CoV-2-induced chronic fatigue-like illness. AIM believes Ampligen may play an important role in addressing this multifaceted disease, including the potential post-infection debilitating aspects.

    "There is a significant risk that SARS-CoV-2, the virus that causes COVID-19, will trigger a large number of chronic fatigue-like cases, similar to what occured in the prior SARS-CoV-1 epidemic," said Equels. "Ampligen's strong history of preclinical outcomes with the SARS-CoV-1 virus gives AIM hope for the drug's potential as a prophalaxis, as a vaccine adjuvant and as an early-onset treatment for the SARS-CoV-2 virus and for COVID-19-induced chronic fatigue-like illness. This potential therapy may be especially important for cancer patients, who face significantly increased risk of severe symptoms or death from COVID-19."

    Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Update:

    • AIM received clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen to Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. AIM has shipped Ampligen to its partner in Argentina, GP Pharm, which is required for testing and ANMAT release. Once final approval by ANMAT is obtained, the commercial launch of Ampligen in Argentina is planned. Further, AIM continues to pursue its Ampligen New Drug Application, or NDA, for the treatment of traditional CFS with the FDA.

    Immuno-oncology Update: Equels further noted, "Given the advances in our third-party funded, investigator-sponsored cancer clinical trials, we believe there is real potential for AIM to become a powerhouse in oncology, as clinical data is reported in these trials. The fact that tens of millions of dollars in grants have been provided to world-class investigator/oncologists at top national cancer centers, from such esteemed organizations as Merck, the U.S. Department of Defense and the National Cancer Institute, clearly supports my faith in Ampligen."

    • Roswell Park Comprehensive Cancer Center and Moffitt Cancer Center have both received "Breakthrough Awards" from the U.S. Department of Defense in Brain Metastatic Breast Cancer. Together, these separate-but-parallel proposed clinical trials are receiving approximately $15 million in federal funding in part with a significant focus upon Ampligen as a potential synergistic agent in combination with several other immunotherapies, including pembrolizumab (Keytruda) and Intron A.
    • The National Cancer Institute issued an award of $14.5 million to Roswell Park Comprehensive Cancer Center to fund five clinical trials in melanoma, colorectal and ovarian cancers. These trials will test chemokine modulation incorporating Ampligen as an immuno-modulator, as part of a strategy to turn "cold" tumors into "hot" tumors.
    • Advanced Recurrent Ovarian Cancer - This Phase 1/2 study of Ampligen as an intraperitoneal therapy in advanced recurrent ovarian cancer has completed 12 subjects in Phase 1; the Phase 1 portion established intraperitoneal safety sufficient to proceed with a larger Phase 2 study (See below). (https://aimimmuno.irpass.com/Hemispherx-Reports-Positive-Safety-and-Survival-Data-in-Phase-1-Stage-4-Ovarian-Cancer-Clinical-Stud) We are awaiting publication of results. https://clinicaltrials.gov/ct2/show/NCT02432378
    • Advanced Recurrent Ovarian Cancer - Based upon the above, a 45-subject follow-up Phase 2 study of advanced recurrent ovarian cancer is underway principally funded via a Merck grant and using cisplatin, pembrolizumab and Ampligen. Enrollment commenced in January 2019 and numerous patients are now well into treatment. https://clinicaltrials.gov/ct2/show/NCT03734692 (https://aimimmuno.irpass.com/Hemispherx-Biopharma-Announces-Commencement-of-a-New-45-Subject-Clinical-Trial-Combining-Ampligen-an)
    • Stage 4 Metastatic Triple Negative Breast Cancer - Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. All patients have been treated or are near completion of treatment. https://www.clinicaltrials.gov/ct2/show/NCT03599453
    • Stage 4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as
      component of chemokine modulatory regimen on colorectal cancer metastatic to liver; the majority of the 12 planned patients enrolled and treated. https://clinicaltrials.gov/ct2/show/NCT03403634
    • Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. https://clinicaltrials.gov/ct2/show/NCT03899987
    • Early-Stage Triple Negative Breast Cancer - Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization; the objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy; the goal of this approach is to increase survival. This study is recruiting and is designed for up to 24 patients. https://clinicaltrials.gov/ct2/show/NCT04081389
    • A study of Ampligen as a drug for late-stage pancreatic cancer is complete and the research team at Erasmus M.C. is currently compiling the final data from this early access approval-based study. We are enthusiastically awaiting the publication of these results.

    With the nation's health care system increasingly focused on the COVID-19 pandemic - and with cancer patients especially at risk for the disease - AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and subsequent reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. However, AIM intends to move forward without delay and we believe the teams at all of the clinical sites are eager to keep forward momentum.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. We recognize that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/601838/AIM-ImmunoTech-Provides-Second-Quarter-2020-Business-Update-and-Reports-Progress-in-Both-COVID-19-and-Cancer-Trials

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  46. OCALA, FL / ACCESSWIRE / July 27, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it will be presenting at the SNN Network Virtual Investor Conference on Monday, August 3, 2020 at 1:30 PM EST. Thomas K. Equels, Chief Executive Officer of AIM Immunotech, will be hosting the presentation and answering questions from investors.

    To access the live presentation, please use the following information:

    SNN Network Virtual Investor Conference 2020
    Date: Monday, August 3, 2020
    Time: 1:30 PM Eastern Time; 10:30 AM Pacific Time
    Webcast: https://www.webcaster4.com/Webcast/Page/2059/35938

    If you would like to book 1-on-1 investor meetings with AIM ImmunoTech, please make sure you are registered for the virtual event here: https://conference.snn.network/signup

    OCALA, FL / ACCESSWIRE / July 27, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it will be presenting at the SNN Network Virtual Investor Conference on Monday, August 3, 2020 at 1:30 PM EST. Thomas K. Equels, Chief Executive Officer of AIM Immunotech, will be hosting the presentation and answering questions from investors.

    To access the live presentation, please use the following information:

    SNN Network Virtual Investor Conference 2020
    Date: Monday, August 3, 2020
    Time: 1:30 PM Eastern Time; 10:30 AM Pacific Time
    Webcast: https://www.webcaster4.com/Webcast/Page/2059/35938

    If you would like to book 1-on-1 investor meetings with AIM ImmunoTech, please make sure you are registered for the virtual event here: https://conference.snn.network/signup.

    1-on-1 meetings will be scheduled and conducted via private, secure video conference through the conference event platform.

    For investors that are unable to attend the live presentation, the webcast replay will be available directly on the conference event platform under the tab "Schedule," at: https://conference.snn.network/page-3371.

    News Compliments of Accesswire

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    About SNN Network

    SNN Network is your multimedia financial news platform for discovery, transparency and due diligence. This is your one-stop hub to find new investment ideas, check in on watchlist, gather the most up-to-date information on the Small-, Micro-, Nano-Cap market with the goal to help you towards achieving your wealth generation goals. Follow the companies YOU want to know more about; read and watch content from YOUR favorite finance and investing influencers; create YOUR own watchlist and screen for ideas YOU'RE interested in; find out about investor conferences YOU want to attend - all here on SNN Network.

    If you would like to attend the SNN Network Virtual Investor Conference, please register here: https://conference.snn.network/signup.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech via Planet MicroCap Showcase



    View source version on accesswire.com:
    https://www.accesswire.com/598983/AIM-ImmunoTech-to-Present-at-the-SNN-Network-Virtual-Investor-Conference-on-Monday-August-3rd

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    • Agreement Important Precursor to Next Step, Enrollment
    • AIM is a Study Collaborator and Financial Supporter

    OCALA, FL / ACCESSWIRE / July 9, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it has entered into a clinical trial agreement (CTA) with Roswell Park Comprehensive Cancer Center to support Roswell Park's Phase 1/2a trial of Ampligen (rintatolimod) in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus. Funding for the clinical trial is provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.

    Thomas K. Equels, CEO of AIM ImmunoTech, commented, "We are excited to team up with Roswell Park, a leading…

    • Agreement Important Precursor to Next Step, Enrollment
    • AIM is a Study Collaborator and Financial Supporter

    OCALA, FL / ACCESSWIRE / July 9, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it has entered into a clinical trial agreement (CTA) with Roswell Park Comprehensive Cancer Center to support Roswell Park's Phase 1/2a trial of Ampligen (rintatolimod) in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus. Funding for the clinical trial is provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.

    Thomas K. Equels, CEO of AIM ImmunoTech, commented, "We are excited to team up with Roswell Park, a leading cancer research center, to test Ampligen as part of an antiviral treatment combination for COVID-19 among cancer patients. Based on the preclinical studies, we are encouraged by the potential for an effective early-onset treatment against this new and deadly virus especially for cancer patients, who face significantly increased risk of severe symptoms or death. We look forward to leveraging this important clinical trial for cancer patients with COVID-19, if successful, into tests of Ampligen in other high risk and immunocompromised COVID-19 groups."

    "We are very grateful for AIM's participation and collaboration in this study, which represents an important potential treatment option for cancer patients with COVID-19," said Pawel Kalinski, MD, PhD, Vice Chair for Translational Research and Rustum Family Professor for Molecular Therapeutics and Translational Research at Roswell Park, who is scientific lead on the new clinical trial as well as five other related studies. "The trial is a signature element of Roswell Park's work to optimize immune-based approaches for treating cancer and infectious diseases, and AIM's support for our vision helped ensure that we could bring this novel approach to patients."

    Enrollment of patients on the trial, which will be conducted at Roswell Park under the clinical leadership of Brahm Segal, MD, Chair of Internal Medicine and Chief of Infectious Diseases at the Buffalo, N.Y.-based cancer center, is expected to begin within 30 days.

    Roswell Park is the sponsor of the new clinical trial (clinicaltrials.gov/NCT04379518), which will test the safety and effectiveness of this combination regimen to clear the SARS-CoV-2 virus from the upper airway in patients with cancer and mild to moderate COVID-19. The initial Phase 1 portion of the study is planned to evaluate 12-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses. Once the Phase I portion is complete, the Phase 2a portion of this study will be initiated with patients randomized into two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa-2b, but will receive best available care.

    AIM ImmunoTech is helping to fund the study and will provide Ampligen (rintatolimod) at no charge for this study. As reported in May 2020, the U.S. Food and Drug Administration has permitted this trial to proceed.

    The CTA formalizes the agreement between AIM and Roswell for the trial and is an important step leading to commencement. AIM believes that Ampligen with interferon alfa-2b may benefit cancer patients with COVID-19. This is a very high-risk population whose death rate may be significantly higher than the general population. Based on the promising results on the immuno-oncology properties of this combination in earlier oncology trials, AIM sees the potential to spur an early innate immune response in cancer patients, with a goal of limiting viral replication and preventing viral transmission to other cells.

    In earlier SARS-CoV-1 studies in mouse models, Ampligen demonstrated a protective effect. Barnard 2006 showed that Ampligen "…reduced virus lung titers to below detectable limits." Day 2009 similarly showed that Ampligen "…led to more rapid decline of virus in the lungs compared with untreated animals" resulting in a 100% survival outcome in the mouse study as opposed to a 100% death rate in the control group. The pathogenic features of SARS-CoV-1 and SARS-CoV-2 (the virus that causes COVID-19) indicate that both viruses utilize the same ACE2 receptor to bind to and infect human cells, utilize almost identical critical transcription-regulatory sequences, and the protein sequences of both viruses share a remarkable 94% homology (https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200128-nCoV-whitepaper.pdf ).

    About Roswell Park Comprehensive Cancer Center

    Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer's grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York.
    Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. In this regard, the FDA authorization of the IND and the Roswell CTA are the first steps and no assurance can be given as to whether the Roswell trial and/or subsequent trials will prove successful. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/596802/AIM-ImmunoTech-Signs-Clinical-Trial-Agreement-with-Roswell-Park-Comprehensive-Cancer-Center-Supporting-Phase-12-Clinical-Trial-of-Ampligen-Combined-with-Interferon-Alfa-2b-in-COVID-19-Patients-with-Cancer

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  47. OCALA, FL / ACCESSWIRE / July 6, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that is has signed a material transfer and research agreement with Japan's National Institute of Infectious Diseases (NIID) and Shionogi & Co., Ltd. (Shionogi), a leading global pharmaceutical company headquartered in Japan, in order to test AIM's drug Ampligen as a potential adjuvant therapy for COVID-19, the new coronavirus infectious disease caused by SARS-CoV-2. Under the agreement, AIM will provide Ampligen samples for various research projects. The details of all preclinical and clinical results will remain confidential until released by NIID and Shionogi.

    This program will be a collaboration between NIID and Shionogi, with AIM supplying the Ampligen. Hideki…

    OCALA, FL / ACCESSWIRE / July 6, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that is has signed a material transfer and research agreement with Japan's National Institute of Infectious Diseases (NIID) and Shionogi & Co., Ltd. (Shionogi), a leading global pharmaceutical company headquartered in Japan, in order to test AIM's drug Ampligen as a potential adjuvant therapy for COVID-19, the new coronavirus infectious disease caused by SARS-CoV-2. Under the agreement, AIM will provide Ampligen samples for various research projects. The details of all preclinical and clinical results will remain confidential until released by NIID and Shionogi.

    This program will be a collaboration between NIID and Shionogi, with AIM supplying the Ampligen. Hideki Hasegawa, MD, PhD, Director of the NIID's Influenza Virus Research Center, and Director of the World Health Organization (WHO) Collaborating Centre for Reference and Research on Influenza, Tokyo is a world-class expert on viral vaccines and Shionogi has been committed to infectious diseases for more than 60 years as their key focus.

    Tom Equels, CEO of AIM ImmunoTech, commented, "We are honored to work with Japan's esteemed NIID, as well as Shionogi, one of the world's premier pharmaceutical companies, in order to accelerate the development of potential COVID-19 vaccines. I truly believe Dr. Hasegawa and the team at Shionogi are among the foremost experts in the field and ideal partners for this exciting collaboration. These new studies are specifically designed to explore Ampligen as a potential vaccine adjuvant. Prior U.S. National Institutes of Health-contracted animal experiments with Ampligen have demonstrated strong prophylactic antiviral activity against the earlier SARS-CoV-1 virus (100% protective survival vs. 100% mortality), which is quite similar to the SARS-CoV-2 virus that causes COVID-19. Prior NIID influenza studies also established Ampligen's strong potential as a viral vaccine adjuvant. We look forward to collaborating with NIID and Shionogi to determine whether Ampligen could be equally effective as a vaccine enhancer for the SARS-CoV-2 virus in combination with promising vaccine candidates."

    About the National Institute of Infectious Diseases (NIID)

    Japan's National Institute of Infectious Diseases aims to carry out extensive and original research projects on a variety of contagious diseases from the standpoint of preventive medicine, improving human health and welfare by suppressing infectious diseases, and clarifying and supporting the scientific background of health and medical administration of the government.

    About Shionogi

    Shionogi & Co., Ltd. is committed to "Protect people worldwide from the threat of infectious diseases." Shionogi is a Japanese pharmaceutical company known for developing Crestor, Tivicay and other successful pharmaceuticals. Dating back to 1878 and incorporated in 1919, the company is listed on the Tokyo Stock Exchange and is a constituent of the Nikkei 225 stock index. The company's areas of focus include infectious diseases, pain/CNS and cancer medicines.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    The Company is also advancing Ampligen® as a potential treatment for COVID-19, the disease caused by the SARS-CoV-2 coronavirus, and believes Ampligen® has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. The U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of Ampligen® in combination with interferon alfa-2b, in cancer patients with COVID-19.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. In this regard, no assurance can be given as to whether the trial with NIID and Shionogi and/or subsequent trails will prove successful. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen® proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen® proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen® generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/596107/AIM-ImmunoTech-Signs-Material-Transfer-and-Research-Agreement-with-Japans-National-Institute-of-Infectious-Diseases-and-Shionogi-a-Leading-Global-Pharmaceutical-Company-to-Test-Ampligen-as-Potential-Vaccine-Adjuvant-for-COVID-19

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  48. OCALA, FL / ACCESSWIRE / June 29, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it has been added to the Russell Microcap® Index, following the annual Russell indexes reconstitution, effective after the market open on June 29, according to a final list of additions posted on June 26.

    Annual Russell indexes reconstitution captures the 4,000 largest US stocks, ranking them by total market capitalization. Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    Tom Equels, CEO of AIM ImmunoTech, commented…

    OCALA, FL / ACCESSWIRE / June 29, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it has been added to the Russell Microcap® Index, following the annual Russell indexes reconstitution, effective after the market open on June 29, according to a final list of additions posted on June 26.

    Annual Russell indexes reconstitution captures the 4,000 largest US stocks, ranking them by total market capitalization. Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    Tom Equels, CEO of AIM ImmunoTech, commented "This addition to the Russell Microcap® Index reflects our progress as we continue to advance both our COVID-19 and oncology programs. Inclusion in the Russell Microcap® Index should also help increase our exposure within the global investment community as we continue to execute on important milestones."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    The Company is also advancing Ampligen® as a potential treatment for COVID-19, the disease caused by the SARS-CoV-2 coronavirus, and believes Ampligen® has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. The U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of Ampligen® in combination with interferon alfa-2b, in cancer patients with COVID-19.

    About FTSE Russell

    FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.

    A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group.

    For more information, visit www.ftserussell.com.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contact:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    SOURCE: AIM ImmunoTech Inc.



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    https://www.accesswire.com/595266/AIM-ImmunoTech-Added-to-Russell-MicrocapR-Index

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  49. Receives clearance from Argentina's FDA to import first shipment of Ampligen® for commercial sale in Argentina

    AIM 'sets sights' on treating COVID-19 induced chronic fatigue in Argentina

    OCALA, FL / ACCESSWIRE / June 15, 2020 / AIM ImmunoTech (NYSE:AIM), today provided an update on the commercial launch of Ampligen® for the treatment of severe Chronic Fatigue Syndrome (CFS) in Argentina. Ampligen®, the first drug ever to receive commercial approval in any country as a treatment for severe ME/CFS, has achieved its next important regulatory step having received import clearance from Argentina's Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT), Argentina's equivalent to the FDA, to import the first shipment of commercial…

    Receives clearance from Argentina's FDA to import first shipment of Ampligen® for commercial sale in Argentina

    AIM 'sets sights' on treating COVID-19 induced chronic fatigue in Argentina

    OCALA, FL / ACCESSWIRE / June 15, 2020 / AIM ImmunoTech (NYSE:AIM), today provided an update on the commercial launch of Ampligen® for the treatment of severe Chronic Fatigue Syndrome (CFS) in Argentina. Ampligen®, the first drug ever to receive commercial approval in any country as a treatment for severe ME/CFS, has achieved its next important regulatory step having received import clearance from Argentina's Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT), Argentina's equivalent to the FDA, to import the first shipment of commercial grade vials of Ampligen® to Argentina. This follows the earlier clearance from the U.S. Food and Drug Administration (FDA) to export Ampligen® to Argentina for commercial sale.

    The next steps in the commercial launch of Ampligen® include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. Once final approval by ANMAT is obtained, GP Pharma will begin distributing Ampligen® in Argentina. GP Pharma's Medical Director and former Head of Evaluation of Medicines at ANMAT, Dr. Gabriel Zeitune noted, "GP Pharma is working with AIM to accelerate the launch of the product in Argentina, providing physicians and patients with a new choice of treatment for CFS that will address an unmet medical need."

    The FDA requires certain regulations be met with a U.S. manufactured drug not yet approved for commecial use by the FDA, before export to a foreign country after that country's commercial approval. In order to receive clearance to export to Argentina, AIM ImmunoTech submitted information on the drug approval processes and standards in Argentina, as well as the issuance by ANMAT of its approval of Ampligen®. The FDA determined on September 19, 2019 that the processes and standards applicable to drug approval in Argentina meet the requirements under section 802(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Those requirements include expert review of safety and effectiveness, good manufacturing practice and quality controls, adverse experience reporting and control of drug labeling and promotion. To the Company's knowledge, this is the first time in over ten years, and only the second time ever, the FDA has made this determination. To view the posted approval of the export of Ampligen® to Argentina on the FDA website, please follow this link: https://www.fda.gov/media/131114/download.

    Argentina, as in most countries, is dealing with the COVID-19 pandemic, which is caused by the SARS-CoV-2 virus. The earlier SARS epidemic in 2002-2003 resulted in high incidences of ME/CFS in survivors. One study in a highly respected, peer reviewed journal found that "…40.3% reported a chronic fatigue problem, and 27.1% met the modified 1994 Centers for Disease Control and Prevention criteria for chronic fatigue syndrome" (JAMA Publication). Also, as we have previously noted, a number of reports have indicated that there may be a similar emerging risk of ME/CFS developing in survivors of COVID-19. As an approved drug in Argentina, we expect that Ampligen will be used to treat patients diagnosed with severe ME/CFS, including those who have survived COVID-19. AIM expects to support this use as a part of its commercial launch in Argentina.

    Dr. Dan Peterson, M.D. is a world-renowned expert in ME/CFS and head of Sierra Internal Medicine. He is currently an investigator in an FDA authorized open-label expanded access treatment protocol of Ampligen. Dr. Peterson stated, "Over the past 30 years of utilizing Ampligen (Poly I, Poly C12U), in FDA authorized clinical trials for patients with Chronic Fatigue Syndrome, the drug has been found to be generally well-tolerated. Based on my experience as a principal investigator in Ampligen trials, I believe that there may be a greater response rate in patients who receive the drug earlier in the disease, after meeting the CFS/ME diagnostic criteria. Therefore, it is possible that tests of Ampligen in patients who have, or have recently had, COVID-19 infection may provide further insight into the pathogenesis of both COVID-19 and CFS/ME and may lead to important therapeutic approaches that alter the course of COVID-19-induced chronic fatigue morbidity."

    Tom Equels, CEO of AIM ImmunoTech, commented, "We are pleased to announce that we have moved, with our local representative GP Pharm, into the final phase required for the commercial launch of Ampligen® in Argentina for the treatment of severe CFS. Ampligen is the only drug approved for severe CFS anywhere in the world. In parallel, we continue to seek regulatory approval for commercial sales to treat ME/CFS patients in the United States. Additionally, as previously noted by AIM, there is emerging concern over the risk of COVID-19 induced chronic fatigue in patients infected during the COVID-19 pandemic. As we enter the final phase of our commercial launch of Ampligen® in Argentina, we also intend to investigate how Ampligen® can be of service should there be a surge of COVID-19 induced chronic fatigue cases worldwide by targeting COVID-19 induced severe chronic fatigue in early onset patients."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    The Company is also advancing Ampligen® as a potential treatment for COVID-19, the disease caused by the SARS-CoV-2 coronavirus, and believes Ampligen® has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. The U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of Ampligen® in combination with interferon alfa-2b, in cancer patients with COVID-19.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, testing will be required to determine whether or not Ampligen will assist in the treatment of COVID-19 induced CFS-like cases. With regard to the Company's activities with Ampligen® generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. With regard to the Company's activities related to COVID-19, significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. In this regard, the FDA approval of the IND is the first step and no assurance can be given as to whether the Roswell trial and/or subsequent trails will prove successful. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen® proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen® proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. Commercialization in Argentina still requires, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch. Approval of rintatolimod for severe CFS in Argentina does not in any way suggest that the Ampligen® NDA in the United States or any comparable application filed in the European Union or elsewhere will obtain commercial approval. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc



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  50. Notes reports of potential surge in CFS-like cases worldwide as a result of COVID-19, the disease caused by the SARS-CoV-2 coronavirus

    OCALA, FL / ACCESSWIRE / June 11, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it has filed a provisional patent application for, among other discoveries, the use of its experimental drug Ampligen® as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue, which shows similarities to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Ampligen®, approved in Argentina, is late-stage in the experimental development pipeline in the U.S.

    While there is ongoing and planned research by the U.S. Centers for Disease Control and Prevention (CDC), National Institutes of Health…

    Notes reports of potential surge in CFS-like cases worldwide as a result of COVID-19, the disease caused by the SARS-CoV-2 coronavirus

    OCALA, FL / ACCESSWIRE / June 11, 2020 / AIM ImmunoTech (NYSE:AIM), today announced that it has filed a provisional patent application for, among other discoveries, the use of its experimental drug Ampligen® as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue, which shows similarities to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Ampligen®, approved in Argentina, is late-stage in the experimental development pipeline in the U.S.

    While there is ongoing and planned research by the U.S. Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH) and other groups to study chronic fatigue in post-COVID-19 patients, the Company believes Ampligen may play an important role in addressing this multi-faceted disease.

    Dr. Charles Lapp of Hunter-Hopkins Center, one of the world's leading experts in ME/CFS, who is one of the investigators treating CFS patients with Ampligen under an FDA-authorized open-label expanded access treatment protocol, noted, "It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS. The investigational immune-modulating antiviral drug Ampligen might have a role to play in this scenario." Although the specific etiology and exact causes of ME/CFS are not known at this time, research suggests there may be multiple variants of the disease with an array of symptoms that often follow severe viral infection. The Institute of Medicine estimates that between 800,000 and 2.5 million U.S. residents live with ME/CFS, and that an estimated three-quarters of these cases were triggered by viral or bacterial infections. Such agents may include the coronavirus, the Epstein-Barr virus, the Ross River virus, and the bacterium, Coxiella burnetii which causes Q fever.

    As recently reported in the Washington Post, researchers are concerned about a potential surge in a CFS-like illness in patients recovering from COVID-19, as similar viral outbreaks in the past have led to increased numbers of post viral fatigue patients. Specifically, the Washington Post article noted that after the first SARS epidemic, one study published in JAMA Internal Medicine found that 27 percent of survivors met the criteria for CFS several years later. As further noted by Simmaron Research, "…the high numbers of younger people being hospitalized for COVID-19 suggests considerable numbers of people in the prime of their lives may have an ME/CFS-like illness in their future."

    Thomas K. Equels, CEO of AIM ImmunoTech, commented, "Worldwide, we may still be in early stages of the pandemic, and yet there are already over 7 million confirmed COVID-19 cases worldwide and approximately 2 million confirmed cases in the U.S. alone. As a result, we believe there exists a significant risk of SARS-CoV-2 induced chronic fatigue among the millions of survivors of COVID-19, as we have witnessed in the prior SARS-CoV-1 epidemic. Given the large amount of clinical data already supporting Ampligen in ME/CFS we look forward to the chance to investigate how Ampligen may be of value should there be a surge of COVID-19 induced CFS-like cases worldwide. We also commend the bipartisan efforts of Senator Markey and other Senators calling for medical research into CFS in the upcoming COVID-19 relief package."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    The Company is also advancing Ampligen® as a potential treatment for COVID-19, the disease caused by the SARS-CoV-2 coronavirus, and believes Ampligen® has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. The U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of Ampligen® in combination with interferon alfa-2b, in cancer patients with COVID-19.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, testing will be required to determine whether or not Ampligen will assist in the treatment of COVID-19 induced CFS-like cases. With regard to the Company's activities with Ampligen® generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. With regard to the Company's activities related to COVID-19, significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. In this regard, the FDA approval of the IND is the first step and no assurance can be given as to whether the Roswell trial and/or subsequent trails will prove successful. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen® proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen® proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. Commercialization in Argentina still requires, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch. Approval of rintatolimod for severe CFS in Argentina does not in any way suggest that the Ampligen® NDA in the United States or any comparable application filed in the European Union or elsewhere will obtain commercial approval. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc



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  51. Ended the First Quarter of 2020 with Cash, Cash Equivalents and Marketable Securities of $31.1 Million

    OCALA, FL / ACCESSWIRE / May 14, 2020 / AIM ImmunoTech (NYSE:AIM) today announced that the U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of the Company's lead asset, Ampligen (rintatolimod), in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus. The Company also provided a corporate business update and reported financial results for the first quarter ended March 31, 2020.

    The new clinical trial, to be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski, MD, PhD, a pioneer…

    Ended the First Quarter of 2020 with Cash, Cash Equivalents and Marketable Securities of $31.1 Million

    OCALA, FL / ACCESSWIRE / May 14, 2020 / AIM ImmunoTech (NYSE:AIM) today announced that the U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of the Company's lead asset, Ampligen (rintatolimod), in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus. The Company also provided a corporate business update and reported financial results for the first quarter ended March 31, 2020.

    The new clinical trial, to be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski, MD, PhD, a pioneer in developing this combination as an investigational treatment for cancer, and Brahm Segal, MD, will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. The phase 1/2b study will enroll approximately 40 patients in two stages. Phase 1 will see 12-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses. Once that initial phase is complete, further study participants will be randomized to two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa but will receive best available care. AIM ImmunoTech intends to be a financial sponsor of the study and will provide Ampligen (rintatolimod) at no charge for this study. Additional information on the clinical trial is available at clinicaltrials.gov.

    In the years that followed the first SARS-CoV-1 epidemic, studies of SARS-CoV-1 in mouse models showed that Ampligen demonstrated a protective effect. Barnard 2006 showed that Ampligen "reduced virus lung titers to below detectable limits." Day 2009 similarly showed that Ampligen "led to more rapid decline of virus in the lungs compared with untreated animals" with a 100% survival outcome in the mouse study as opposed to a 100% death rate in the control group. These controlled studies evidence Ampligen's activity against SARS-CoV-1.

    A comparison of important pathogenic features of SARS-CoV-1 and SARS-CoV-2 (the virus that causes COVID-19) indicated that both viruses utilized the same ACE2 receptor to bind to and infect human cells. In addition, important genetic sequences of both viruses were almost identical. These similarities among the analyzed genetic sequences and the use of the same receptor suggested a potential likely extension of the antiviral effect of Ampligen seen with the above-mentioned SARS-CoV-1 experiments to that of SARS-CoV-2, the virus that caused the COVID-19 pandemic.

    Dr. David Strayer, Chief Scientific Officer, stated, "We are extremely pleased that Dr. Kalinski and his team at Roswell Park have obtained FDA authorization to initiate this combinational study using Ampligen in combination with interferon for cancer patients with COVID-19. Historically, Ampligen was shown to have synergistic antitumor and antiviral activity when combined with human interferons in studies published in the 1980s. A clinical study was conducted using Ampligen in combination with interferon in patients with solid tumors. The study showed that the combination was generally well-tolerated. AIM announced February 11, 2020, the filing of three provisional patent applications surrounding Ampligen for use against COVID-19. These applications cover the use of Ampligen, both alone and in combination with interferon as an early onset therapy for COVID-19. Further, we filed for Ampligen as a proposed intranasal coronavirus vaccine enhancer that would combine Ampligen with inactive SARS-CoV-2. At AIM, we believe that Ampligen has the potential to play several important roles in the war against COVID-19."

    "Our experience with the combination of interferon alfa with a viral mimic such as Ampligen applied to achieve modulation of the cancer microenvironment convinced us that this could be an effective strategy also against COVID-19," said Dr. Kalinski, who is Vice Chair for Translational Research and Rustum Family Professor for Molecular Therapeutics and Translational Research at Roswell Park, and is scientific lead on the cancer center's studies with this combination. "We hope that these two drugs, given together, will limit viral replication in the infected cells, prevent viral transmission to other cells and spur early innate immune response in cancer patients with COVID-19, before the virus spreads and they become seriously ill. While for decades, immuno-oncology drew heavily from virology, this development suggests that recent progress in the immuno-oncology field may allow us to return the favor and to accelerate the development of new treatments of infectious diseases."

    Thomas K. Equels, CEO of AIM ImmunoTech, commented, "Since this January, when we filed our provisional patent applications, we have been focused on advancing Ampligen as a potential treatment for COVID-19 and believe Ampligen has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. Dr. Segal, Dr. Kalinski and their teams at Roswell Park, with genius and creativity in this pandemic, are focused on saving the lives of cancer patients. Roswell deserves great credit for exploring the important and potentially life-saving role of Ampligen in cancer patients with COVID-19, a patient population they are dedicated to serving. AIM is very pleased to see that the FDA has authorized this human study at Roswell Park to conduct research on Ampligen in combination with interferon alfa as a possible antiviral treatment for COVID-19 for high risk cancer patients."

    Equels further noted, "Following the results of this trial, we hope to expand tests of Ampligen to other high risk and immunocompromised COVID-19 groups as the death rate in these groups is often five to seven times higher than the general population. Ampligen has an extremely well developed safety profile, which is based on more than 100,000 IV doses administered to humans, and has shown minimal side effects in multiple clinical trials which makes it an acceptable drug candidate for study in vulnerable patient populations."

    Ellen Lintal, CFO of AIM ImmunoTech, stated, "I am pleased to report we have a solid balance sheet with over $31.1 million in cash, cash equivalents and marketable securities as of March 31, 2020. The strength of our balance sheet allows us to continue to advance both our COVID-19 and oncology programs. As we move forward in the new COVID-19 trials, it is likely we will see a corresponding increase in expenses; however, we continue to carefully manage expenses which has allowed us to generally minimize our burn rate."

    Update on Cancer Clinical Trials/Programs

    Ampligen clinical trials are currently underway at academic cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors. AIM will promptly update stockholders and the market as more information on these studies becomes available. However, with the nation's health care system increasingly focused on the COVID-19 pandemic - and with cancer patients especially at risk for the disease - AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for some delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency.

    First Quarter Financial Highlights:

    • As of March 31, 2020, AIM had cash, cash equivalents and marketable securities of $31.1 million, as compared to $8.8 million as of December 31, 2019.
    • Research and development expenses for the first quarter ended March 31, 2020 were $898,000, compared to $928,000 for the first quarter ended March 31, 2019. General and administrative expenses for the first quarter ended March 31, 2020 were $2.3 million, compared to $2.8 million for the first quarter ended March 31, 2019.
    • Net loss for the first quarter ended March 31, 2020 was $3.8 million, or $0.22 per share, compared to a net loss of $3.5 million, or $2.91 per share, for the first quarter ended March 31, 2019.

    The Company's complete financial results are available in the Company's Form 10-Q filed with the Securities and Exchange Commission on May 14, 2020 which is available at www.sec.gov and on the Company's website.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. In this regard, the FDA authorization of the IND is the first step and no assurance can be given as to whether the Roswell trial and/or subsequent trails will prove successful. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc

    View source version on accesswire.com:
    https://www.accesswire.com/589832/AIM-ImmunoTech-Announces-FDA-Authorization-for-First-Human-Ampligen-Trial-in-COVID-19-Patients-with-Cancer-Provides-Corporate-Business-Update-for-the-First-Quarter-of-2020

    View Full Article Hide Full Article
  52. OCALA, FL / ACCESSWIRE / April 29, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that CEO Thomas K. Equels is scheduled to present at Maxim's Infectious Disease Virtual Conference to be held on May 5, 2020. Mr. Equels will discuss the urgent need for a therapeutic and vaccine for COVID-19 and give a brief overview of Ampligen® and its current and potential indications.

    Panel Discussion Details:

    Panel Session Title: COVID-19 (Vaccines and Monitoring)

    Time and Date: Tuesday, May 5, 2020, 2:15 p.m. ET

    To register for the virtual conference, please click here: http://go.pardot.com/l/652223/2020-04-02/j1mqg

    OCALA, FL / ACCESSWIRE / April 29, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that CEO Thomas K. Equels is scheduled to present at Maxim's Infectious Disease Virtual Conference to be held on May 5, 2020. Mr. Equels will discuss the urgent need for a therapeutic and vaccine for COVID-19 and give a brief overview of Ampligen® and its current and potential indications.

    Panel Discussion Details:

    Panel Session Title: COVID-19 (Vaccines and Monitoring)

    Time and Date: Tuesday, May 5, 2020, 2:15 p.m. ET

    To register for the virtual conference, please click here: http://go.pardot.com/l/652223/2020-04-02/j1mqg

    About Maxim's Infectious Disease Virtual Conference

    The Infectious Disease Virtual Conference is being presented by Maxim Group, LLC (Maxim). In addition to the keynote presentation by Dr. Roger J. Pomerantz, Chief Executive Officer and Chairman of ContraFect Corporation, there will be three panels of companies in various stages of development, from early-stage to near commercialization, that represent the next wave of innovation in the healthcare industry. Please contact Soraya Dorce (sdorce@maximgrp.com) or visit M-Vest for more information and to register for the conference.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer, and triple-negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. Neither can any assurances be made as to any future immuno-oncology clinical trials related to the matter herein. No assurance can be given as to whether the current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. These and other risks are described more fully in AIM's filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

    CONTACT:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc

    View source version on accesswire.com:
    https://www.accesswire.com/587498/AIM-ImmunoTechs-CEO-to-Present-at-Maxims-Infectious-Disease-Virtual-Conference

    View Full Article Hide Full Article
  53. OCALA, FL / ACCESSWIRE / April 20, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that Chief Executive Officer, Thomas K. Equels is scheduled to present at the Planet Microcap Showcase 2020 on Wednesday, April 22 at 10:40 AM Eastern Time. Mr. Equels will be hosting the presentation and answering questions from investors.

    To access the live presentation, please use the following information:

    Planet MicroCap Showcase Virtual Investor Conference 2020

    Date: Wednesday, April 22, 2020

    Time: 10:40 AM Eastern Time; 7:40 AM Pacific Time

    Webcast: https://www.webcaster4.com/Webcast/Page/2059/34145

    OCALA, FL / ACCESSWIRE / April 20, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that Chief Executive Officer, Thomas K. Equels is scheduled to present at the Planet Microcap Showcase 2020 on Wednesday, April 22 at 10:40 AM Eastern Time. Mr. Equels will be hosting the presentation and answering questions from investors.

    To access the live presentation, please use the following information:

    Planet MicroCap Showcase Virtual Investor Conference 2020

    Date: Wednesday, April 22, 2020

    Time: 10:40 AM Eastern Time; 7:40 AM Pacific Time

    Webcast: https://www.webcaster4.com/Webcast/Page/2059/34145

    If you would like to book 1on1 investor meetings with AIM ImmunoTech, please make sure you are registered for the virtual event here: https://www.planetmicrocapshowcase.com/signup

    1on1 meetings will be scheduled and conducted via private, secure video conference through the conference event platform.

    If you can't make the live presentation, all company presentations "webcasts" will be available directly on the conference event platform on this link under the tab "Schedule": https://www.planetmicrocapshowcase.com/presenting-companies

    News Compliments of Accesswire

    About Planet MicroCap Showcase

    Planet MicroCap Showcase brings together promising companies with well-known and influential microcap, investors, fund managers and newsletter writers for three days of company presentations, one-on-one meetings, and networking.

    If you would like to attend the Planet MicroCap Showcase, please register here: https://planetmicrocapshowcase.com/signup

    About AIM ImmunoTech Inc

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. Neither can any assurances be made as to any future immuno-oncology clinical trials related to the matter herein. No assurance can be given as to whether the current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech via Planet MicroCap Showcase

    View source version on accesswire.com:
    https://www.accesswire.com/585617/AIM-ImmunoTechs-CEO-to-Present-at-the-Planet-Microcap-Showcase-Virtual-Investor-Conference-2020

    View Full Article Hide Full Article
  54. OCALA, FL / ACCESSWIRE / April 6, 2020 / AIM ImmunoTech (NYSE:AIM) today announced it has entered into a Material Transfer and Research Agreement (MTA) with Shenzhen Smoore Technology Limited. According to a market survey report by Frost & Sullivan, Smoore is the world's largest vaping device manufacturer in terms of revenue in 2019, whose products include but are not limited to high-tech inhalation devices. The purpose of the MTA is to research in China the efficacy of Smoore's inhalation delivery device using Ampligen, AIM's flagship drug, which has been approved for ME/CFS in Argentina and experimental through phase 3 clinical trials in the U.S. AIM believes Ampligen has potential as a prophylactic/early-onset therapeutic against COVID-19…

    OCALA, FL / ACCESSWIRE / April 6, 2020 / AIM ImmunoTech (NYSE:AIM) today announced it has entered into a Material Transfer and Research Agreement (MTA) with Shenzhen Smoore Technology Limited. According to a market survey report by Frost & Sullivan, Smoore is the world's largest vaping device manufacturer in terms of revenue in 2019, whose products include but are not limited to high-tech inhalation devices. The purpose of the MTA is to research in China the efficacy of Smoore's inhalation delivery device using Ampligen, AIM's flagship drug, which has been approved for ME/CFS in Argentina and experimental through phase 3 clinical trials in the U.S. AIM believes Ampligen has potential as a prophylactic/early-onset therapeutic against COVID-19, the disease caused by SARS-CoV-2.

    AIM's pluripotent Toll Like Receptor 3 (TLR3) agonist, Ampligen, has yielded pre-clinical 100% protective efficacy against SARS-CoV-1 viral infection in duplicate experiments using a mouse model in U.S. National Institutes of Health-contracted animal testing (see: Day 2009 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787736/] and Barnard 2006 [https://journals.sagepub.com/doi/abs/10.1177/095632020601700505]) and AIM has human safety data (see: Overton 2014 [https://www.sciencedirect.com/science/article/pii/S0264410X14010457?via%3Dihub]) showing Ampligen to be generally well tolerated when administered intranasally to humans in addition to the extensive safety data from approximately 100,000 IV doses in humans.

    "All this leads to the strong hypothesis, which AIM and Smoore jointly seek to prove through this experimental program. We believe that Ampligen, when administered deep into the lungs at the first signs of the disease via the Smoore device - designed to carefully distribute different-sized particles of Ampligen - may initiate a therapeutic TLR3 response throughout the upper and lower respiratory system that will stop the SARS-CoV-2 virus in its tracks," states AIM CEO Thomas K. Equels. "Smoore is without question one of the world's leading innovators of vaporization technology. We are excited and eager to test Ampligen using Smoore's advanced inhalation device. If we can make the administration of Ampligen as easy as vaping and delivering nicotine, and testing proves Ampligen has COVID-19 efficacy as a prophylaxis, then this combination has the potential to be a powerful and easily self-administered tool in the global effort to stop the COVID-19 pandemic."

    "As the world's largest vaping device manufacturer in terms of revenue in 2019 and global leader in offering vaping technology solutions with advanced R&D technology, we are excited to have this opportunity to work with AIM in exploring the medical inhalation of Ampligen in the combat of COVID-19 pandemic. We believe conventional medical inhalation devices can be miniaturized and mass produced with better dosage and aerosol particle size control with our proprietary technology. Given the pre-clinical protective efficacy against SARS-CoV-1 viral infection and human safety data established by our partner, with proper vaporization of Ampligen via an easy-to-use device, we see a potential to help more people in the world in combating the current COVID-19 pandemic, and this collaboration represents an important first step." Commented by Dr. Zhiqiang Shi, Chief Science Officer of Smoore.

    AIM Chief Science Officer David Strayer, MD, adds: "The clear goal of this research is to develop a self-administered inhalation device capable of safely delivering an Ampligen atomized mist deep into the pulmonary airways. We believe this approach may have potential as a prophylactic/early-onset therapeutic for COVID-19."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. Assuming Ampligen timely proves effective, significant testing will be required to determine if the Smoore device will be able to safely deliver Ampligen in an appropriate dose without diminishing its efficacy against COVID-19. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced herein. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. There also is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/584074/AIM-ImmunoTech-and-Shenzhen-Smoore-Technology-Announce-an-Agreement-to-Research-Utilizing-an-Innovative-Smoore-Inhalation-Delivery-Device-and-Ampligen-rintatolimod-as-a-Potential-Easy-To-Use-Treatment-Approach-for-the-SARS-CoV-2-Pandemic

    View Full Article Hide Full Article
  55.  

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    FORM 8-K

     

    CURRENT REPORT

     

    Pursuant to Section 13 or 15(d) of the

    Securities Exchange Act of 1934

     

    Date of Report (Date of earliest event reported)

    April 6, 2020 (April 1, 2020)

     

    AIM IMMUNOTECH INC.

    (Exact name of registrant as specified in its charter)

     

    Delaware   001 - 27072   52-0845822
    (state or other jurisdiction   (Commission   (I.R.S. Employer
    of incorporation)   File Number)   Identification No.)

     

    2117 SW Highway 484, Ocala FL   34473
    (Address of principal executive offices)   (Zip Code)

     

    Registrant’s telephone number, including area

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    FORM 8-K

     

    CURRENT REPORT

     

    Pursuant to Section 13 or 15(d) of the

    Securities Exchange Act of 1934

     

    Date of Report (Date of earliest event reported)

    April 6, 2020 (April 1, 2020)

     

    AIM IMMUNOTECH INC.

    (Exact name of registrant as specified in its charter)

     

    Delaware   001 - 27072   52-0845822
    (state or other jurisdiction   (Commission   (I.R.S. Employer
    of incorporation)   File Number)   Identification No.)

     

    2117 SW Highway 484, Ocala FL   34473
    (Address of principal executive offices)   (Zip Code)

     

    Registrant’s telephone number, including area code: (352) 448-7797

     

    AIM Immunotech Inc.

    (Former name or former address, if changed since last report)

     

    Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

     

    [  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
       
    [  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
       
    [  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
       
    [  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

     

    Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

     

    Emerging growth company [  ]

     

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

     

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of each class   Trading Symbol   Name of each exchange on which registered
    Common Stock, par value $0.001 per share   AIM   NYSE American

     

     

     

     
     

     

    Item 1.01 Entry into a Material Definitive Agreement.

     

    On April 1, 2020, we entered into a Material Transfer and Research Agreement (the “Agreement”) with Shenzhen Smoore Technology Limited (“Smoore”). Pursuant to the Agreement, we are providing Smoore with Ampligen and Smoore will be conducting in vitro tests using its porous ceramic atomizer technology. Initial testing will study the particle size of various Ampligen concentrations in aqueous solutions obtainable using Smoore’s technology. The goal of these studies is to establish a reproducible method to obtain an Ampligen containing atomized mist that can deliver biologically active Ampligen deep into the lung airways of humans.

     

    We have filed herewith as Exhibit 10.1, the Material Transfer and Research Agreement with Smoore, which is incorporated herein by reference, and the foregoing description of the Agreement is qualified in its entirety by reference thereto.

     

    Item 7.01. Regulation FD Disclosure.

     

    On April 6, 2020, we issued a press release related to the Agreement. A copy of the press release is furnished herewith as Exhibit 99.1.

     

    The information in this item, including Exhibit 99.1, is “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, if and to the extent such subsequent filing specifically references the information herein as being incorporated by reference in such filing.

     

    Cautionary Statement

     

    This report and the press release furnished as Exhibit 99.1 contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. Assuming Ampligen timely proves effective, significant testing will be required to determine if the Smoore device will be able to safely deliver Ampligen in an appropriate dose without diminishing its efficacy against COVID-19. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced herein. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company’s activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. There also is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. Any forward-looking statements set forth herein speak only as of the date hereof. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

     

    Item 9.01. Financial Statements and Exhibits.

     

    (d) Exhibits.

     

    Exhibit No.   Description
         
    10.1   April 1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited.
    99.1   Press Release dated April 6, 2020.

     

     
     

     

    SIGNATURES

     

    Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

     

      AIM IMMUNOTECH INC.
         
    April 6, 2020 By: /s/ Thomas K. Equels
        Thomas K. Equels, CEO

     

     

     

     

    Exhibit 10.1

     

    MATERIAL TRANSFER AND RESEARCH AGREEMENT

     

    This Material Transfer and Research Agreement (“Agreement”) is made as of March [correct date], 2020 (“Effective Date”) by and between AIM ImmunoTech, Inc. (“AIM”), located at 2117 SW Highway 484, Ocala, FL 34473, USA, and Shenzhen Smoore Technology Limited (“Smoore”), located at Block 16th, Dongcai Industry Park, Gushu Village, Xixiang Town, Bao’an District Shenzhen, People’s Republic of China (“PRC”). AIM and Smoore shall be referred to individually as a “Party” and together as the “Parties”.

     

    WHEREAS, Smoore wishes to receive Confidential Information pertaining to AIM’s inventions and know-how and also samples of AIM’s drug Ampligen® for the sole purpose of conducting the Research Project, and

     

    WHEREAS, AIM is willing to provide Confidential Information and Ampligen® to Smoore solely for purposes of conducting the Research Project.

     

    NOW THEREFORE, in consideration of the premises and the mutual agreements and undertakings set forth herein, the Parties hereby agree as follows:

     

    1. DEFINITIONS

     

    Whenever used in this Agreement, the following terms will have the following meanings:

     

    1.1 “Confidential Information” means any confidential or proprietary information, knowledge, intellectual property, pre-clinical and clinical information or data, technical and/or non-technical material or property, relating to RNA pharmaceutical products and technologies, including but not limited to double-stranded RNA compounds and in particular the double-stranded RNA compound trademarked Ampligen® provided under this Agreement. A Party disclosing Confidential Information shall be a “Disclosing Party” and a Party receiving the same shall be a “Receiving Party.”

     

    1.2 The “Research Project”, described in Exhibit A and appended by reference, is to be conducted by Smoore utilizing Confidential Information and Ampligen® and is being funded by entities independent of AIM.

     

    1.3 The “Principal Investigator” means the person(s) responsible for the day-to-day supervision of the Research Project as identified in Exhibit A.

     

    1
     

     

      2. PROVISION OF MATERIAL, CONFIDENTIAL INFORMATION AND PERFORMANCE OF THE RESEARCH PROJECT

     

    2.1 AIM shall provide to Smoore with such Ampligen® as described in Exhibit A and any relevant information about Ampligen® which may be reasonably requested by Smoore from time to time for purposes of the Research Project, and which shall be used by Smoore solely for purposes of conducting the Research Project.

     

    Other than the 30 aliquots (1.0 ml each) of Ampligen® (2.5 mg/ml) herein, the availability of Ampligen® shall be at the discretion of AIM. Any Ampligen® aliquots delivered pursuant to this Agreement shall not be sold, distributed or otherwise made available by Smoore to any other party for any other purpose. There is no obligation from AIM to supply any further amounts of Ampligen®.

     

    The results of the data must be disclosed to AIM on a real-time basis. Therefore Smoore will regularly provide AIM with reports on the data as detailed in Article 5.

     

    2.2 The Parties shall provide to each other such Confidential Information as is reasonably necessary for purposes of the Research Project.

     

    2.3 The Parties shall utilize the Confidential Information exchanged solely for purposes of conducting the Research Project.

     

    2.4 Smoore shall promptly and diligently pursue the Research Project in a scientific manner, documenting in reproducible form the work performed and results achieved in pursuing the Research Project and disclose updates on the Research Project to AIM as described in Article 5 herein.

     

    2.5 Any Ampligen® delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. AIM makes no representations and extends no warranties of any kind, either expressed or implied. Specifically, there are no expressed or implied warranties of merchantability or fitness for a particular purpose or that the use of the material shall not infringe any patent, copyright, trademark or other proprietary rights. AIM shall fully inform Smoore about the previous and current usage information of Ampligen®, and any relevant hazardousness or safety information upon Ampligen® such as proper usage, storage or disposal of it.

     

    2.6 Without prejudice to the provisions of Article 4.1, and except as may be expressly provided in this Agreement, this Agreement shall not be construed to grant any license or other rights from either Party to the other Party for any trademarks, copyrights, patents, patent applications, trade secrets or other proprietary rights of it. In particular, no rights are provided from AIM to use Ampligen® and any related trademarks, copyrights, patents, patent applications, trade secrets or other proprietary rights of AIM for profit-making, commercial or research purposes, including but not limited to the sale of Ampligen®, used in manufacturing, provision of service to a third party in exchange for consideration, or use in research or consulting by a commercial or not-for-profit entity under which that entity obtains rights of any sort to research results. For the purpose of clarity, all rights to Ampligen® through any mechanism of administration for the use of Ampligen® belong to AIM. All rights to device, atomizer, and heating or vaporizing technology used to administer Ampligen®, belong to Smoore.

     

    2
     

     

    3. INTELLECTUAL PROPERTY

     

    3.1 Ownership of and title to all trademarks, copyrights, patents, patent applications and other intellectual property rights in all inventions, discoveries, and other intellectual property, including the rights to Ampligen®, Rintitolimod, or any similar form of double stranded RNA product which activates or is a Toll Like Receptor 3 Agonist (all herein “Intellectual Property”) through any method of administration including inhalation, belong to AIM. The rights to any atomization, nebulation, vaporization devices, and heating or vaporizing technology developed by Smoore for purposes of medical administration of Ampligen® or any similar product belong to Smoore.

     

    3.2 The Parties agree that there is no scenario where there is any inventorship. Anything related to vaping devices clearly belong to Smoore whereas anything related to Ampligen® or any similar double stranded RNA clearly belong to AIM.

     

    3.3 In the future the Parties may discuss and agree regarding the possibility of using said items together but there is no obligation on the part of either Party to enter into such an agreement.

     

    4. CONFIDENTIALITY

     

    4.1 (a) The Parties shall employ the same degree of care to keep all Confidential Information confidential as they employ with respect to their own information of like importance, which shall not constitute less than a reasonable standard of care, and will not use any Confidential Information except for the express purposes of this Agreement and shall not disclose any Confidential Information received from the other Party to any third party, including but not limited to any third party investors of Smoore, except to employees and/or consultants who are entitled to know such Confidential Information for purposes of carrying out the objectives of this Agreement, and who are obligated to abide by all of the provisions of this Agreement. Nothing in this paragraph shall prevent a Disclosing Party from disclosing or using its own Confidential Information as it deems appropriate. Furthermore, Smoore may need to share the information received by Smoore from AIM regarding Ampligen® with a third party which is essential for the Research Project, provided that Smoore has obtained AIM’s written consent for involving such third-party before the disclosure of any information. In this connection, Smoore shall inform AIM of (1) the third-party background, and (2) the extent to which the information shall be disclosed. Smoore shall only disclose the information after the third-party has assumed the same confidentiality obligations herein by signing a confidentiality agreement with Smoore.

     

    (b) The Receiving Party shall ensure that its employees and/or consultants will abide by the terms of this Agreement.

     

    3
     

     

    4.2 All Confidential Information shall remain the property of the Disclosing Party. Upon the written request of a Disclosing Party or upon termination or expiration of this Agreement, all tangible Confidential Information received from the Disclosing Party (including all copies thereof and samples) shall be promptly returned to the Disclosing Party provided that the Receiving Party may retain one (1) copy of such tangible Confidential Information in a secure location for purposes of identifying its obligations under this Agreement.

     

    4.3 The obligations of confidentiality and non-use as set forth in this Article 4 shall not apply to any portion of the Confidential Information that:

     

      (a) is or becomes public or available to the general public without being wrongfully obtained or through breach of Agreement or is developed independently of Confidential Information received from the disclosing party;
         
      (b) was known to and evidenced by the Receiving Party’s written records prepared prior to the date of this Agreement;
         
      (c) is properly obtained by the Receiving Party from a third party with a valid legal right to disclose such Confidential Information and such third party is not under any confidentiality obligations to the Disclosing Party; or
         
      (d) is released by the Disclosing Party to a third party without restriction.

     

    4.4 In the event that a Receiving Party is requested or required (by deposition, interrogatories, request for information or documents in legal proceedings, subpoena, civil investigative demand or other similar process) to disclose any of the Confidential Information, the Receiving Party shall provide the Disclosing Party with prompt written notice of any such request or requirement so the Disclosing Party may seek a protective order or other appropriate remedy and/or waive compliance with the provisions of this Confidentiality Agreement. In the absence of a protective order or other remedy or the receipt of a signed written waiver, the Receiving Party or its representatives are nonetheless, in the written opinion of their counsel, legally compelled to disclose Confidential Information to any governmental or regulatory body or else stand liable for contempt or suffer such other censure or penalty, the Receiving Party may, without liability hereunder, disclose to such body only that portion of the Confidential Information which the Receiving Party is legally required to be disclosed, provided that the Receiving Party exercised efforts to allow the Disclosing Party to use its reasonable efforts to preserve the confidentiality of the Confidential Information.

     

    4.5 Nothing in this Agreement shall be construed as giving a Receiving Party any right, title, interest in or ownership of the Confidential Information.

     

    4
     

     

    4.6 The provisions of this Article 4 shall survive any termination or expiry of this Agreement.

     

    4.7 Smoore acknowledges that AIM is a public company and that any agreements including this Agreement that are reached between Smoore and AIM will be considered material and as such AIM will be filing reports in AIM’s 8K, 10K and 10Qs that address AIM contracting relationships. This is an ongoing obligation that is required if the Parties are to engage in any business relationship. AIM has attached a sample draft of such an 8K using this agreement as an example for Smoore’s information. Smoore may disclose similar information to the PRC authorities as required by PRC laws and regulations. Further, AIM understands that Smoore is under the listing process at the main board of the Hong Kong Stock Exchange (HKEX). AIM acknowledges that, under the Listing Rules, the HKEX may, at its discretion, request Smoore to disclose the business relationship with AIM which may be deemed as material information for the disclosure purpose.

     

    5. DISCLOSURE

     

    5.1 Smoore shall on a quarterly basis provide information in writing to AIM regarding the progress, status and results of the Research Project (including efficacy and safety data) and also any reports related to the Research Project submitted to any ethics committee(s) or regulatory agencies.

     

    5.2 If requested by AIM, Smoore’s Principal Investigator(s) shall confirm no later than five (5) days any oral progress reports with follow-up summary written reports. The Principal Investigator(s) shall provide AIM with a final written report within thirty (30) days after the conclusion of each study described in Exhibit A. The written reports will include descriptions of the methods used and results obtained together with any other pertinent findings from the Research Project.

     

    5.3 During the Research Project, AIM shall promptly (or in a timely manner appropriate to the level of risk) report to Smoore any information that could affect the conduct of study. In each case, Smoore and the Principal Investigator(s) shall be free to communicate these findings to the ethics committee(s) or regulatory agencies.

     

    6. INDEMNIFICATION

     

    6.1 Smoore shall indemnify, defend and hold harmless AIM, its directors, officers, employees against any third party claims, including any reasonable attorney’s fees for defending those claims (each a “Claim”), to the extent a Claim arises out of improper use, storage or disposal of the drug(s), unless any such Claim is solely due to the negligence of AIM.

     

    7. TERMINATION

     

    7.1 This Agreement shall terminate upon the earliest of (a) the completion of the Research Project, (b) the written agreement signed by authorized representatives of the Parties, or (c) one (1) year from the Effective Date and is renewable for three (3) consecutive one (1) year periods upon the mutual agreement of both parties in writing ninety (90) days prior to the expiration of this agreement.

     

    5
     

     

    8. LEGAL COMPLIANCE AND AUTHORIZATION

     

    8.1 Legal Compliance. Each Party shall comply in all material respects with all U.S. federal and state laws and regulations applicable to the conduct of its business pursuant to this Agreement.

     

    8.2 Authorization.

     

      (a) Smoore hereby represents and certifies to AIM that all requisite action on the part of Smoore and its officers and directors necessary for the authorization, execution and delivery of this Agreement and the performance of all obligations of Smoore hereunder has been taken.
         
      (b) AIM hereby represents and warrants to Smoore that all requisite action on the part of AIM and its officers and directors necessary for the authorization, execution and delivery of this Agreement and the performance of all obligations of Smoore hereunder has been taken.

     

    9. MISCELLANEOUS

     

    9.1 Notices. All notices required or permitted to be given under this Agreement shall be given in writing and be effective when such notices have been either personally delivered (including delivery by FedEx or other couriers) or when sent by facsimile to the relevant addresses as follows:

     

    To: Shenzhen Smoore Technology Limited

    Block 16, Dongcai Industry Park

    Gushu Village, Xixiang Town

    Bao’an District, Shenzhen

    PRC

    Attn: Derek Zhu, General Counsel

    Email: derek.zhu@smoorecig.com

     

    To: AIM ImmunoTech, Inc.:

    2117 SW Highway 484

    Ocala, Florida 34473

    U.S.A.

    Attn: Tom Equels

    Email: Tom.Equels@aimimmuno.com

     

    or such other address as either Party may hereinafter specify by written notice to the other under this Section 9.1. Such notices and communications shall be deemed effective on the date of personal delivery or upon confirmed answer back by facsimile.

     

    9.2 Entire Agreement, Amendment and Waivers. This Agreement, including all Exhibits hereto, constitutes the entire agreement between the Parties with respect to the specific subject matter hereof and supersedes all prior agreements and understandings, oral or written, with respect to such matters. This Agreement may not be modified, amended or terminated, nor may any term hereof be waived, except by an instrument in writing, signed by the authorized representatives of the Parties.

     

    6
     

     

    9.3 Severability and Enforcement. If any provision of this Agreement, or the application thereof to any person, place, or circumstance, is held by a court of competent jurisdiction to be invalid, unenforceable or void, as written in whole or in part, such provision shall be deemed to be amended to the extent necessary to be enforceable and applied by such court in the broadest possible manner, consistent with enforceability, and the remainder of this Agreement and such provisions as applied to other persons, places, and circumstances shall remain in full force and effect.

     

    9.4 Assignment and Binding Effect. This Agreement shall be binding upon and inure solely to the benefit of each Party, and, as such, this Agreement may not be assigned nor may any of the rights or obligations be delegated, without the prior approval and express written consent of the Parties.

     

    9.5 Remedies. The Parties agree that they will be entitled to seek injunctive relief against the other Party in the event of any breach of the confidentiality terms of this Agreement, in addition to any other relief (including damages) available under this Agreement or under law.

     

    9.6 Governing Law. (a) The validity, interpretation, enforceability and performance of this Agreement shall be governed by and construed in accordance with the laws of the State of New York, U.S.A., without regard to the application of conflict laws.

     

    (b) Arbitration of this Agreement may only be brought per the arbitration terms of the previously executed confidentiality agreement.

     

    9.7 Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which shall constitute one and the same Agreement.

     

    9.8 Waiver. Neither Party’s waiver of any breach or failure to enforce any of the terms and conditions of this Agreement, at any time, shall in any way affect, limit or waiver such Party’s right thereafter to enforce and compel strict compliance with every term and condition of this Agreement.

     

    9.9 Headings. The headings in this Agreement are for the convenience of reference only and shall not affect its interpretation.

     

    9.10 Construction. This Agreement has been jointly prepared on the basis of the mutual understanding of the Parties and shall not be constructed against either Party by reason of such Party’s being the drafter of the same.

     

    9.11 Exhibits, Schedules and Attachments. Any and all exhibits, schedules and attachments referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference.

     

    7
     

     

    IN WITNESS WHEREOF the Parties have executed this Agreement as of the Effective Date.

     

    AIM IMMUNOTECH, INC.        
               
    By: /s/ Thomas K. Equels   Date: April 1, 2020  
    Name: Thomas K. Equels        
    Title: C.E.O.        

     

    SHENZHEN SMOORE TECHNOLOGY LIMITED        
               
    By: /s/ Zhiqiang Shi   Date: 3/30/2020  
    Name: Zhiqiang Shi        
    Title: Director of Fundamental Research Institute at Smoore        

     

    8
     

     

    Exhibit A

     

    AIM ImmunoTech Inc will ship 30 aliquots (1.0 ml each) of Ampligen® (2.5 mg/ml) to Smoore for purposes of conducting the in vitro tests using Smoore’s porous ceramic atomizer technology. Initial testing will study the particle size of various Ampligen concentrations in aqueous solutions obtainable using Smoore’s technology. The goal of these studies is to establish a reproducible method to obtain an Ampligen containing atomized mist that can deliver biologically active Ampligen deep into the lung airways of humans.

     

    As the project moves forward AIM will supply additional aliquots of Ampligen as required, for example for in vivo animal testing that will be necessary for both safety and efficacy studies including efficacy studies of atomized Ampligen against COVID-19 caused by SARS-COV-2.

     

    9

     

    Exhibit 99.1

     

    AIM ImmunoTech and Shenzhen Smoore Technology Announce an Agreement to Research Utilizing an Innovative Smoore Inhalation Delivery Device and Ampligen (rintatolimod) as a Potential, Easy-To-Use Treatment Approach for the SARS-CoV-2 Pandemic

     

    OCALA, Fla. – April 6, 2020 — AIM ImmunoTech (NYSE:AIM) today announced it has entered into a Material Transfer and Research Agreement (MTA) with Shenzhen Smoore Technology Limited. According to a market survey report by Frost & Sullivan, Smoore is the world’s largest vaping device manufacturer in terms of revenue in 2019, whose products include but are not limited to high-tech inhalation devices. The purpose of the MTA is to research in China the efficacy of Smoore’s inhalation delivery device using Ampligen, AIM’s flagship drug, which has been approved for ME/CFS in Argentina and experimental through phase 3 clinical trials in the U.S. AIM believes Ampligen has potential as a prophylactic/early-onset therapeutic against COVID-19, the disease caused by SARS-CoV-2.

     

    AIM’s pluripotent Toll Like Receptor 3 (TLR3) agonist, Ampligen, has yielded pre-clinical 100% protective efficacy against SARS-CoV-1 viral infection in duplicate experiments using a mouse model in U.S. National Institutes of Health-contracted animal testing (see: Day 2009 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787736/] and Barnard 2006 [https://journals.sagepub.com/doi/abs/10.1177/095632020601700505]) and AIM has human safety data (see: Overton 2014 [https://www.sciencedirect.com/science/article/pii/S0264410X14010457?via%3Dihub]) showing Ampligen to be generally well tolerated when administered intranasally to humans in addition to the extensive safety data from approximately 100,000 IV doses in humans.

     

    “All this leads to the strong hypothesis, which AIM and Smoore jointly seek to prove through this experimental program. We believe that Ampligen, when administered deep into the lungs at the first signs of the disease via the Smoore device — designed to carefully distribute different-sized particles of Ampligen — may initiate a therapeutic TLR3 response throughout the upper and lower respiratory system that will stop the SARS-CoV-2 virus in its tracks,” states AIM CEO Thomas K. Equels. “Smoore is without question one of the world’s leading innovators of vaporization technology. We are excited and eager to test Ampligen using Smoore’s advanced inhalation device. If we can make the administration of Ampligen as easy as vaping and delivering nicotine, and testing proves Ampligen has COVID-19 efficacy as a prophylaxis, then this combination has the potential to be a powerful and easily self-administered tool in the global effort to stop the COVID-19 pandemic.”

     

    “As the world’s largest vaping device manufacturer in terms of revenue in 2019 and global leader in offering vaping technology solutions with advanced R&D technology, we are excited to have this opportunity to work with AIM in exploring the medical inhalation of Ampligen in the combat of COVID-19 pandemic. We believe conventional medical inhalation devices can be miniaturized and mass produced with better dosage and aerosol particle size control with our proprietary technology. Given the pre-clinical protective efficacy against SARS-CoV-1 viral infection and human safety data established by our partner, with proper vaporization of Ampligen via an easy-to-use device, we see a potential to help more people in the world in combating the current COVID-19 pandemic, and this collaboration represents an important first step.” Commented by Dr. Zhiqiang Shi, Chief Science Officer of Smoore.

     

    AIM Chief Science Officer David Strayer, MD, adds: “The clear goal of this research is to develop a self-administered inhalation device capable of safely delivering an Ampligen atomized mist deep into the pulmonary airways. We believe this approach may have potential as a prophylactic/early-onset therapeutic for COVID-19.”

     

     
     

     

    About AIM ImmunoTech Inc.

     

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM’s flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

     

    Cautionary Statement

     

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. Assuming Ampligen timely proves effective, significant testing will be required to determine if the Smoore device will be able to safely deliver Ampligen in an appropriate dose without diminishing its efficacy against COVID-19. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced herein. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company’s activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. There also is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

     

    Contacts:

     

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: aim@crescendo-ir.com

     

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: IR@aimimmuno.com

     

     

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  56. OCALA, FL / ACCESSWIRE / April 6, 2020 / AIM ImmunoTech (NYSE:AIM) today announced it has entered into a Material Transfer and Research Agreement (MTA) with Shenzhen Smoore Technology Limited. According to a market survey report by Frost & Sullivan, Smoore is the world's largest vaping device manufacturer in terms of revenue in 2019, whose products include, but are not limited to, high-tech inhalation devices. The purpose of the MTA is to research in China the efficacy of Smoore's inhalation delivery device using Ampligen, AIM's flagship drug, which has been approved in Argentina for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and is experimental through Phase 3 clinical trials in the United States. AIM believes…

    OCALA, FL / ACCESSWIRE / April 6, 2020 / AIM ImmunoTech (NYSE:AIM) today announced it has entered into a Material Transfer and Research Agreement (MTA) with Shenzhen Smoore Technology Limited. According to a market survey report by Frost & Sullivan, Smoore is the world's largest vaping device manufacturer in terms of revenue in 2019, whose products include, but are not limited to, high-tech inhalation devices. The purpose of the MTA is to research in China the efficacy of Smoore's inhalation delivery device using Ampligen, AIM's flagship drug, which has been approved in Argentina for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and is experimental through Phase 3 clinical trials in the United States. AIM believes Ampligen has potential as a prophylactic/early-onset therapeutic against COVID-19, the disease caused by SARS-CoV-2.

    AIM's pluripotent Toll Like Receptor 3 (TLR3) agonist, Ampligen, has established pre-clinical 100% protective efficacy against SARS-CoV-1 viral infection in U.S. National Institutes of Health-contracted animal experimentation (see: Day 2009 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787736/] and Barnard 2006 [https://journals.sagepub.com/doi/abs/10.1177/095632020601700505]) and AIM has human safety data (see: Overton 2014 https://www.sciencedirect.com/science/article/pii/S0264410X14010457?via%3Dihub) showing Ampligen to be generally well tolerated when administered intranasally to humans.

    "All this leads to the strong hypothesis, which AIM and Smoore jointly seek to prove through this experimental program. We believe that Ampligen, when administered deep into the lungs at the first signs of the disease via the Smoore device - designed to carefully distribute different-sized particles of Ampligen - may initiate a therapeutic TLR3 response throughout the upper and lower respiratory system that will stop the SARS-CoV-2 virus in its tracks," states AIM CEO Thomas K. Equels. "Smoore is without question one of the world's leading innovators of inhalation technology. We are excited and eager to test Ampligen using Smoore's advanced inhalation device. If we can make the administration of Ampligen as easy as vaping and delivering nicotine, and testing proves Ampligen has COVID-19 efficacy as a prophylaxis, then this combination has the potential to be a powerful and easily self-administered tool in the global effort to stop the COVID-19 pandemic."

    "As the world's largest vaping device manufacturer in terms of revenue in 2019 and global leader in offering vaping technology solutions with advanced R&D technology, we are excited to have this opportunity to work with AIM in exploring the medical inhalation of Ampligen in the fight against the COVID-19 pandemic. We believe conventional medical inhalation devices can be miniaturized and mass produced with better dosage and aerosol particle size control with our proprietary technology. With proper vaporization of Ampligen via an easy-to-use device, we see a potential to help more people in the world in combating the current COVID-19 pandemic," commented Dr. Zhiqiang Shi, Chief Science Officer of Smoore.

    AIM Chief Science Officer David Strayer, MD, adds: "The clear goal of this research is to develop a self-administered inhalation device capable of safely delivering an Ampligen atomized mist deep into the pulmonary airways. We believe this approach may have potential as a prophylactic/early-onset therapeutic for COVID-19."

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. In addition, no assurance can be given that future pre-clinical or clinical trials will be successful, nor that they will lead to a successful treatment or treatment delivery system. The safety and efficacy of the use of the Smoore technology with Ampligen has not been previously established, and that is the purpose of this experimental collaboration. No assurance can be given that future studies will not result in findings that are different from those reported in the referenced studies. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc

    View source version on accesswire.com:
    https://www.accesswire.com/583967/AIM-ImmunoTech-and-Shenzhen-Smoore-Technology-Announce-an-Agreement-to-Research-Utilizing-an-Innovative-Smoore-Inhalation-Delivery-Device-and-Ampligen-rintatolimod-as-a-Potential-Easy-To-Use-Treatment-Approach-for-the-SARS-CoV-2-Pandemic

    View Full Article Hide Full Article
  57. OCALA, FL / ACCESSWIRE / March 31, 2020 / AIM ImmunoTech (NYSE:AIM) announces financial results for the fiscal year ended December 31, 2019, and provides a business update.

    2019 Financial Highlights

    As of December 31, 2019, AIM had cash, cash equivalents and marketable securities of $8.778 million, compared with $1.825 million as of December 31, 2018.

    Research and development expenses for 2019 were $4.651 million, compared with $4.778 million for 2018. General and administrative expenses for 2019 were $7.039 million, compared with $6.201 million for 2018.

    The net loss from continuing operations for 2019 was $9.533 million, or $2.62 per share, compared with $9.827 million, or $9.77 per share, for 2018.

    Please refer to the full 10-K for complete…

    OCALA, FL / ACCESSWIRE / March 31, 2020 / AIM ImmunoTech (NYSE:AIM) announces financial results for the fiscal year ended December 31, 2019, and provides a business update.

    2019 Financial Highlights

    As of December 31, 2019, AIM had cash, cash equivalents and marketable securities of $8.778 million, compared with $1.825 million as of December 31, 2018.

    Research and development expenses for 2019 were $4.651 million, compared with $4.778 million for 2018. General and administrative expenses for 2019 were $7.039 million, compared with $6.201 million for 2018.

    The net loss from continuing operations for 2019 was $9.533 million, or $2.62 per share, compared with $9.827 million, or $9.77 per share, for 2018.

    Please refer to the full 10-K for complete details.

    Update on COVID-19 Pandemic Response

    Since the outbreak of SARS-CoV-2 - which causes the disease COVID-19 - AIM has been actively engaged in determining whether its drug Ampligen could be an effective treatment for this virus. The company believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus as both a protective prophylaxis and an early-onset therapy.

    AIM has reached several significant COVID-19 milestones over the past two months:

    • AIM filed provisional patent applications to secure the company's intellectual property before seeking domestic and international research partners.
    • Japan's National Institute of Infectious Diseases (NIID) agreed to experiment with Ampligen as a potential treatment for COVID-19. The testing and research will be conducted by laboratories at the NIID and the University of Tokyo. AIM will report immediately upon receipt of results.
    • AIM engaged ChinaGoAbroad (CGA) to facilitate pre-clinical and clinical trials of Ampligen in the People's Republic of China (PRC).
    • AIM is in discussions with GP-Pharm in Argentina to advance Ampligen for potential use against COVID-19. Ampligen is an approved drug in Argentina for use against myalgic encephalomyelitis/chronic fatigue syndrome.
    • AIM is in discussions in The Netherlands - where Ampligen was recently used to treat pancreatic cancer patients - to explore expedited pre-clinical and clinical trials of Ampligen.

    AIM is currently targeting the United States, Europe, Asia and Argentina for new clinical trials and, as necessary steps before clinical trials could begin, the company is in the process of soliciting one or more sites and qualified principal investigators in one or more countries. Protocols for potential clinical trial are in the final stages of development. AIM intends, as a next step, to as rapidly as possible seek Institutional Review Board approvals and governmental authorizations to commence the clinical trials of Ampligen as both a protective prophylaxis and an early-onset therapy.

    Update on Cancer Clinical Trials/Programs

    Six Ampligen clinical trials are currently underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors. The company will promptly update stockholders and the market as more information on these studies becomes available. Cancer patients are especially at risk with COVID-19. AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients as a consequence of the COVID-19 medical emergency.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/583177/AIM-ImmunoTech-Reports-2019-Year-end-Financial-Results

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  58. OCALA, FL / ACCESSWIRE / March 26, 2020 / AIM ImmunoTech (NYSE:AIM) today announced that it is actively seeking investigators and sites for clinical testing of Ampligen as a protective prophylaxis and an early-onset treatment for COVID-19, the disease caused by the SARS-CoV-2 coronavirus.

    The company is targeting the United States, Europe, Asia and Argentina for its clinical trials and, as necessary steps before clinical trials could begin, the company is in the process of soliciting one or more sites and qualified principal investigators in one or more countries. Protocols for potential clinical trial are in the final stages of development. AIM intends, as a next step, to as rapidly as possible seek Institutional Review Board approvals and…

    OCALA, FL / ACCESSWIRE / March 26, 2020 / AIM ImmunoTech (NYSE:AIM) today announced that it is actively seeking investigators and sites for clinical testing of Ampligen as a protective prophylaxis and an early-onset treatment for COVID-19, the disease caused by the SARS-CoV-2 coronavirus.

    The company is targeting the United States, Europe, Asia and Argentina for its clinical trials and, as necessary steps before clinical trials could begin, the company is in the process of soliciting one or more sites and qualified principal investigators in one or more countries. Protocols for potential clinical trial are in the final stages of development. AIM intends, as a next step, to as rapidly as possible seek Institutional Review Board approvals and governmental authorizations to commence the clinical trials of Ampligen as both a protective prophylaxis and an early-onset therapy.

    AIM has reached several significant COVID-19 milestones over the past two months:

    • AIM filed provisional patent applications to secure the company's intellectual property before seeking domestic and international research partners.
    • Japan's National Institute of Infectious Diseases (NIID) agreed to experiment with Ampligen as a potential treatment for COVID-19. The testing and research will be conducted by laboratories at the NIID and the University of Tokyo. AIM will report immediately upon receipt of results.
    • AIM engaged ChinaGoAbroad (CGA) to facilitate pre-clinical and clinical trials of Ampligen in the People's Republic of China (PRC).
    • AIM is in discussions with GP-Pharm in Argentina to advance Ampligen for potential use against COVID-19. Ampligen is an approved drug in Argentina for use against myalgic encephalomyelitis/chronic fatigue syndrome.
    • AIM is in discussions with myTomorrows and Erasmus MC, Rotterdam - where Ampligen was recently used to treat pancreatic cancer patients - to explore expedited pre-clinical and clinical trials of Ampligen.

    "Since the first news of the outbreak, our focus and efforts have been devoted to developing Ampligen as an intranasal and oral protective prophylaxis and as an intravenous early-onset treatment for this highly pathogenic coronavirus. As front-line workers fighting the pandemic around the world know - and as their families know - they are putting their lives on the line every day by working with COVID-19 patients. For example, health care workers account for a reported 13% of cases in Spain. I have a son and a nephew who are doctors, a daughter and a sister who are nurses, three nephews who are EMTs, and one nephew who is a police officer. This fight is personal to me, as it is to countless others around the globe. In the absence of an effective vaccine, the development of early-stage therapies such as Ampligen may be critical both to the health of our front-line workers and to blunt the spread of the pandemic," said AIM CEO Thomas K. Equels.

    AIM also continues to await results in the six ongoing clinical trials studying the effects of Ampligen on different types of cancers, where steady progress continues to be made. The company will update stockholders and the market as more information on these studies becomes available. To that point, today the company filed a duly executed amendment to its Material Transfer and Research Agreement with Roswell Park Comprehensive Cancer Center, attaching an exhibit showing the clinical trials currently underway or on deck. Cancer patients are especially at risk with COVID-19. We also recognize that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients as a consequence of the COVID-19 medical emergency.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/582484/AIM-ImmunoTech-Announces-Further-Efforts-to-Establish-Clinical-Trials-Assessing-Ampligen-as-a-Potential-Protective-and-Early-Onset-Treatment-for-the-Current-COVID-19-Pandemic

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  59. OCALA, FL / ACCESSWIRE / March 9, 2020 / AIM ImmunoTech (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the National Institute of Infectious Diseases (NIID) in Japan will begin testing AIM's drug Ampligen as a potential treatment for COVID-19, the new coronavirus infectious disease caused by SARS-CoV-2. The experimental program will be conducted at both the NIID and the University of Tokyo.

    The testing and research are being conducted by Hideki Hasegawa, MD, PhD, Director of the NIID's Influenza Virus Research Center, and Director of the World Health Organization (WHO) Collaborating Centre for Reference and…

    OCALA, FL / ACCESSWIRE / March 9, 2020 / AIM ImmunoTech (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the National Institute of Infectious Diseases (NIID) in Japan will begin testing AIM's drug Ampligen as a potential treatment for COVID-19, the new coronavirus infectious disease caused by SARS-CoV-2. The experimental program will be conducted at both the NIID and the University of Tokyo.

    The testing and research are being conducted by Hideki Hasegawa, MD, PhD, Director of the NIID's Influenza Virus Research Center, and Director of the World Health Organization (WHO) Collaborating Centre for Reference and Research on Influenza, Tokyo and Takeshi Ichinohe, PhD, Department of Pathology at the NIID, Department of Biological Science and Technology, Tokyo University of Science.

    "As we have been saying all along, this emerging pandemic is caused by a virus that has nearly identical regulatory RNA sequences to the original SARS coronavirus, known as SARS-CoV-1, in respect to pathogenesis. This means that the prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus. The WHO has recently renamed this emerging, highly pathogenic virus as SARS-CoV-2," said AIM CEO Thomas K. Equels. "Ampligen had excellent antiviral activity against the earlier SARS coronavirus in U.S. National Institutes of Health-contracted animal experiments. In those studies of SARS-infected mice, Ampligen stands out as the only drug tested that conferred a significant survival effect: 100% of the Ampligen-treated mice survived, while none of the untreated mice survived. Because SARS-CoV-2 shares many critical similarities with SARS-CoV-1, Ampligen may have an important role to play in developing a protective early-onset therapy for this new highly pathogenic coronavirus in humans, where currently there is no known effective therapy. We are proud to work with Japan's universally esteemed NIID in the battle to curb this emerging potential pandemic."

    Ampligen has established itself as a broad-spectrum antiviral with an extremely well-developed safety profile (See: "Ampligen as an Antiviral," safety slides 7-15, at https://aimimmuno.com/events-presentations/).

    AIM will provide stockholders and the market with updates on results as they are available.

    Referenced NIH-contracted studies of Ampligen versus SARS:

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. No assurance can be given that future studies will not result in findings that are different from those reported in the referenced studies. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc

    View source version on accesswire.com:
    https://www.accesswire.com/579582/AIM-ImmunoTechs-Drug-Ampligen-to-Be-Tested-by-Japans-National-Institute-of-Infectious-Diseases-as-a-Potential-Treatment-for-the-New-SARS-Coronavirus-SARS-CoV-2-Responsible-for-the-New-Human-Infectious-Disease-COVID-19

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  60. OCALA, FL / ACCESSWIRE / February 27, 2020 / AIM ImmunoTech (NYSE:AIM, or the Company)), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the Company has joined with ChinaGoAbroad (CGA) to facilitate the entry of AIM's experimental drug Ampligen into the People's Republic of China (PRC) for use as a prophylactic/early-onset therapeutic against COVID-19, the new SARS-like coronavirus infection that has reached epidemic proportions.

    CGA is a member-based online information platform and offline advisory firm serving to facilitate two-way international transactions relating to the PRC in close collaboration with the China…

    OCALA, FL / ACCESSWIRE / February 27, 2020 / AIM ImmunoTech (NYSE:AIM, or the Company)), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the Company has joined with ChinaGoAbroad (CGA) to facilitate the entry of AIM's experimental drug Ampligen into the People's Republic of China (PRC) for use as a prophylactic/early-onset therapeutic against COVID-19, the new SARS-like coronavirus infection that has reached epidemic proportions.

    CGA is a member-based online information platform and offline advisory firm serving to facilitate two-way international transactions relating to the PRC in close collaboration with the China Overseas Development Association (CODA), which had up until recently reported to the PRC National Development and Reform Commission (NDRC), which in turn reports to the State Council (China's cabinet). CGA is already involved in China's ongoing efforts to halt the growing COVID-19 epidemic and, among other engagements, has been assigned to assist with the international purchase by Sinopharm Group - a Chinese state pharmaceutical company - of technology, masks, gowns and gloves.

    "AIM is working aggressively to advance the introduction of Ampligen into China, in order to provide the Chinese people with a potential first line of defense against the deadly COVID-19 virus. AIM and CGA have taken this first step to facilitate discussions with the Chinese government for Ampligen's entry into China as a targeted prophylactic/early-onset therapy," said AIM CEO Thomas K. Equels. "Ampligen achieved a 100% survival rate, as compared to 100% mortality in the untreated control animals, in SARS animal experiments after the outbreak in 2003. In these experiments, Ampligen was administered to mice prior to and shortly after infection. The Company believes that Ampligen may provide similarly effective prophylaxis against COVID-19, as both coronaviruses are extremely similar in key regulatory RNA sequences essential for coronaviral replication."

    Ampligen has a well-developed safety profile based on approximately 100,000 IV doses administered to humans and is ready to deploy for clinical trials in China if trials are approved by the PRC authorities and if Ampligen is authorized for export under the FDA regulations governing the export of investigational drugs for use in a sudden and immediate national emergency. (See: "Ampligen as an Antiviral," safety slides 7-15, at https://aimimmuno.com/events-presentations/).

    ChinaGoAbroad CEO Jesse T H Chang states: "Ampligen has the potential to be a groundbreaking life-saving protective therapy. This drug may be useful for doctors, nurses, healthcare professionals, first responders and people exposed to the virus. Without better protection, infected professionals in our medical teams may continue to become martyrs on the frontlines of the battle against this highly contagious virus. If Ampligen works in the clinic against COVID-19 the same way it worked in the SARS experiments, a protective drug such as Ampligen - unlike a mask and gloves - would provide immunological protection from the inside. For those inadvertently exposed to the virus, it may provide hope against infection or development of the disease. Such a protective therapy would also become an important public health tool against exposed people spreading the disease. We are excited and indeed honored to work with AIM ImmunoTech on this endeavor so important to the Chinese people."

    In addition, you can find AIM's most recent stockholder update detailing Ampligen's potential in the epidemic here: https://aimimmuno.irpass.com/AIM-ImmunoTech-Issues-Stockholder-Update-on-the-Potential-Role-of-Ampligen-for-Use-Against-the-Wuhan-Coronavirus-Epidemic

    About AIM ImmunoTech Inc

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of the Wuhan Coronavirus in humans and no assurance can be given that it will be the case. The presentation and stockholders' letter referenced in this press release refer to a number of studies. No assurance can be given that future studies will not result in findings that are different from those reported in the referenced studies. This press release related to potential activity in China. Operating in foreign countries such as China carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential operations in China will not be adversely affected by these risks. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc

    View source version on accesswire.com:
    https://www.accesswire.com/578078/AIM-ImmunoTech-Joins-with-ChinaGoAbroad-for-an-Ampligen-China-Entry-Against-COVID-19-the-New-SARS-like-Coronavirus-Disease-Epidemic

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  61. 奥卡拉,佛罗里达州 – 2020218 – AIM ImmunoTech纽约证券交易所股票代码AIM是一家专注于研究和开发治疗免疫疾病、病毒性疾病和多种癌症疗法的免疫制药公司。今天公司向股东提交了关于使用安普利近治疗新型冠状病毒,并将其用于疫苗研发的最新信息。该公司的主打产品安普利近已在阿根廷获准上市,在荷兰获准进行早发治疗,并且在美国进行了多次由FDA授权的临床试验。这封信为我们为何要在意义重大且前景未卜的武汉冠状病毒领域不断推动探索,提供了详细的科学依据,您也可通过公司网站获取以下信件。

    尊敬的股东:

    如您所知,过去两年中,公司的重心一直放在免疫肿瘤学领域的安普利近rintatolimod)的研发上,而且这仍然是我们的首要任务。人类正面临着近二十年来出现的第三种高致病性和致命性的人类冠状病毒威胁,这里我们指的是致命的武汉冠状病毒。该疾病的正式名称为COVID-192019冠状病毒疾病),两个月前才在中国武汉出现首例病例。截止今天确诊人数已超过6万,证实死亡人数超过1,000,且该病毒仍然在医院等机构大肆传播。在最近一项关于医院感染的研究中,其致死率为4.3% (https://jamanetwork.com/journals/jama/fullarticle/2761044)。情况日益危急,任何增加死亡率的突变都将在全球范围内产生重大影响。鉴于这种情况,我指示AIM ImmunoTech团队结合武汉冠状病毒及其临床综合征的已知基因组特性,以及安普利近在这种高危环境中作为预防性治疗剂的潜力,对安普利近的抗病毒特性进行重新检测。

    到目前为止,我们已经初步提出了针对武汉疫情治疗和疫苗的构想。 之后我们还提交了与武汉冠状病毒有关的安普利近

    奥卡拉,佛罗里达州 – 2020218 – AIM ImmunoTech纽约证券交易所股票代码AIM是一家专注于研究和开发治疗免疫疾病、病毒性疾病和多种癌症疗法的免疫制药公司。今天公司向股东提交了关于使用安普利近治疗新型冠状病毒,并将其用于疫苗研发的最新信息。该公司的主打产品安普利近已在阿根廷获准上市,在荷兰获准进行早发治疗,并且在美国进行了多次由FDA授权的临床试验。这封信为我们为何要在意义重大且前景未卜的武汉冠状病毒领域不断推动探索,提供了详细的科学依据,您也可通过公司网站获取以下信件。

    尊敬的股东:

    如您所知,过去两年中,公司的重心一直放在免疫肿瘤学领域的安普利近rintatolimod)的研发上,而且这仍然是我们的首要任务。人类正面临着近二十年来出现的第三种高致病性和致命性的人类冠状病毒威胁,这里我们指的是致命的武汉冠状病毒。该疾病的正式名称为COVID-192019冠状病毒疾病),两个月前才在中国武汉出现首例病例。截止今天确诊人数已超过6万,证实死亡人数超过1,000,且该病毒仍然在医院等机构大肆传播。在最近一项关于医院感染的研究中,其致死率为4.3% (https://jamanetwork.com/journals/jama/fullarticle/2761044)。情况日益危急,任何增加死亡率的突变都将在全球范围内产生重大影响。鉴于这种情况,我指示AIM ImmunoTech团队结合武汉冠状病毒及其临床综合征的已知基因组特性,以及安普利近在这种高危环境中作为预防性治疗剂的潜力,对安普利近的抗病毒特性进行重新检测。

    到目前为止,我们已经初步提出了针对武汉疫情治疗和疫苗的构想。 之后我们还提交了与武汉冠状病毒有关的安普利近临时专利申请(请参阅:https://aimimmuno.irpass.com/AIM-ImmunoTech-Files-Three-Provisional-Patent-Applications-Surrounding-AmpligenR-for-Use-Against-the-SARS-like-Wuhan-2019-Novel-Coronavirus)。现在,我们正在积极行动,将检验情况提交给美国、中国和日本政府。

    早在武汉冠状病毒疫情之初,我们的AIM ImmunoTech团队就立即开展工作。在美国国立卫生研究院(NIH)进行的动物实验中,我们的药物安普利近对冠状病毒SARS具有强大的抗病毒活性,实现了 100%的存活率。

    Day 2009 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787736/)Barnard 2006 (https://journals.sagepub.com/doi/abs/10.1177/095632020601700505)NIH对感染SARS的小鼠的研究中,安普利近作为唯一一种具有显著抗病毒/存活效果的药物脱颖而出。我们知道,如果武汉病毒与SARS在关键基因组和致病性方面有相似之处,那么在目前尚无有效疗法的情况下,对于这种新的致命病毒的早发治疗和预防我们具有相当的优势。此外,武汉冠状病毒在医院和隔离区的毒性尤其强,因此这种预防性保护措施可能有助于减缓疾病的传播。

    我们迅速获得了新病毒的RNA序列,并将其与SARS病毒的RNA序列进行了比较。正如您将在动物中使用安普利近进行SARS实验概述之后的章节中看到的,SARS病毒在病毒复制的关键区域的RNA序列与武汉冠状病毒几乎相同。因此,我们认为安普利近很可能对武汉冠状病毒具有与对SARS冠状病毒类似的抗病毒活性。这些对安普利近作为SARS抗病毒治疗的实验评估是在大约15年前的上一次SARS爆发后进行的。当时,在美国国立卫生研究院(NIH)进行的动物实验中,安普利近是唯一具有显著疗效的药物,与SARS感染对照组100%的死亡率相比,其存活率达到100%。在这两项研究(Barnard 2006Day 2009)中,对SARS小鼠模型进行了评估。研究中使用的安普利近药剂产生了病毒抗体和存活效应,即SARS病毒的肺滴度降低至检测水平以下(Barnard 2006)和存活率提高(Day 2009)。重要的是,这些效果是在临床上可达到/耐受的人类剂量水平上获得的。 安普利近是唯一在临床上可达到的血清/剂量水平有效的药物(Strayer 2014 http://www.eurekaselect.com/123324/article)。 Barnard2006)研究了安普利近和rIFN-αB/ D抑制BALB / c小鼠肺中SARS病毒(厄巴尼株)效价的能力。用10 mg / kg剂量的安普利近可以完全将病毒抑制到可检测水平以下,这相当于一个平均体重的人(70公斤)用药700毫克,这也被证明是一个普遍耐受的剂量水平(Thompson 1996 https://www.ncbi.nlm.nih.gov/pubmed/8874076) rIFN-αB / D将病毒滴度抑制到低于可检测的水平,但在小鼠中需要100,000 IU的剂量,这相当于500 x 106 IU的极高的人类剂量,而且在临床上还不可用。Day(2009)研究了一种新的适应小鼠的SARS-CoV毒株作为致死模型。只有在剂量为10 mg/kg/天的情况下,安普利近的存活率才为100%

    综上所述,在评估预防和存活方面,只有安普利近才有明显的反应(Day 2009Barnard 2006Strayer 2014)。上述与SARS相关的实验表明,与其他药物不同,安普利近具有明显的早发治疗和预防作用。此外,安普利近与其他有效的抗病毒药物联合使用时展现出明显的协同作用,可强化针对其他病毒的抗病毒治疗方案。尽管目前尚无针对武汉冠状病毒的疗法,但如果未来开发出针对这种冠状病毒的基于传统的抗病毒疗法,我们相信传统抗病毒疗法与安普利近的组合可能产生与我们在安普利近中所见到相似的协同作用,因为安普利近的免疫学作用机制与典型的抗病毒药物和而不同且互为补充。(请参阅:https://aimimmuno.com/events-presentations/ “ 安普利近作为一种抗病毒药物”,幻灯片46-50 )。

    我们认为,武汉冠状病毒与SARS的显著相似性表明,安普利近对武汉冠状病毒具有相似的潜在疗效的可能性很高。我们的分析比较了SARS和武汉冠状病毒的关键转录调控序列,其中我们分析了SARS-cov和武汉冠状病毒,发现了两者之间极为明显的相似性。我们的结果列在表1中,并会在下文进一步探讨。这些分析序列的相似性表明,SARS实验中发现的安普利近的抗病毒作用可能会扩展到武汉冠状病毒。我们为有兴趣进行更深入分析的人提供了这些额外的详细信息——不过,长话短说,在这些关键领域,两种病毒存在大约99%的相似性。

    冠状病毒复制利用一种独特的转录机制来产生嵌套的mRNAs。转录调控序列(TRS)为每个mRNA选择正确的阅读框。我们将Mara(2003) (https://science.sciencemag.org/content/300/5624/1399.long)鉴定的SARS-CoV5个开放阅读框(ORF)TRS(转录调控序列)与引起covid19的武汉冠状病毒进行了比较,详情见表1

    1两种高致病性人类冠状病毒(HPHuCoV)TRS序列比较

    HPHuCoV

    碱基

    开放阅读框*

    TRS 序列**

    SARS

    Wuhan

    60

    63

    Leader

    UCUCUAAACGAACUUUAAAAUCUGUG

    UCUCUAAACGAACUUUAAAAUCUGUG

    SARS

    Wuhan

    21,479

    21,549

    S (spike)

    CAACUAAACGAAC

    CAACUAAACGAAC

    SARS

    Wuhan-

    25,252

    25,378

    ORF3

    CACAUAAACGAACUU

    CACAUAAACGAACUU

    SARS

    Wuhan

    26,104

    26,232

    Envelope

    UGAGUACGAACUU

    UGAGUACGAACUU

    SARS

    Wuhan

    26,341

    26,466

    M

    GGUCUAAACGAACUAACU

    GGUCUAAACGAACUAAAU

    *开放阅读框(即,编码蛋白质)

    **Marra等人 https://science.sciencemag.org/content/300/5624/1399.long

    我们发现,与最近从中国一名SARS样疾病患者中分离出的武汉冠状病毒相比,SARS冠状病毒(Tor2)的前五个ORFTRS序列,除了冠状病毒膜(M)蛋白的一个单核苷酸(C/ a)外,其余均相同。因此,SARS冠状病毒的5TRS序列(LeaderS (spike)ORF3Envelope)中的4个与武汉冠状病毒的序列完全相同。M蛋白具有单个核苷酸变化:SARS冠状病毒中的A更改为武汉冠状病毒的C 因此,这两种冠状病毒的TRS序列几乎相同, 84/85个核甘酸完全相同(同源性达99%)。

    SARS冠状病毒和COVID-19的一个重要的致病特征是它们都利用相同的ACE2受体与人类细胞结合并感染人类细胞。这种ACE2受体的相似性,以及分析的关键调控病毒基因组序列的相似性表明,在这些SARS实验中,安普利近的治疗作用可能会扩展到武汉冠状病毒。这一点很重要,因为目前尚无针对在医院内部传播性极强的预防性疗法,这意味着您很容易在类似医院的环境中被传染。这种病毒在类似医院的环境中繁殖。这意味着医护人员和接触者迫切需要有效的早发预防性疗法。

    除了作为抗病毒药的安普利近之外,我们还提出了一种疫苗概念,即利用灭活的武汉/冠状病毒疫苗加上安普利近来生产一种疫苗,既可对特定的病毒靶点进行免疫,也会对冠状病毒和其他类似冠状病毒的突变提供交叉保护,相当于创造出一种潜在的通用冠状病毒疫苗。

    我们以流感来类比。 如论文所述,在Overton2014)论文和Ichinohe / Hasegawa20072010)的小鼠和猴子实验结果中,由AIM资助进行的人类临床结果显示了在流感病毒中,安普利近如何以双链RNAdsRNA)和通常耐受性良好的选择性Toll样受体3TLR3)激动剂,具有诱导先天性和适应性免疫反应的能力,疫苗在小鼠、灵长类动物和人类具有强大的免疫学影响,显示出表位扩散和交叉保护/交叉反应。 TLR3在人的气道上皮细胞上高浓度表达,并作为识别系统启动许多呼吸道病原体先天免疫反应和随后的适应性免疫反应。

    鼻子和呼吸道的粘膜表面为安普利近作为TLR3激动剂提供了理想环境,发挥其显著的能力来增强对呼吸道病原体(如流感病毒,腺病毒和冠状病毒)的先天性和适应性免疫反应。 经鼻内滴注季节性流感疫苗中包含的灭活或减毒流感病毒,当与安普利近结合使用时,已显示出能够诱导对人类高度致病的流感病毒(例如在小鼠、灵长类动物和人类身上的各种H5N1演化支,A / Indonesia / 5/2000A / HongKong / 483/97A / Vietnam / 1194/2004)的广泛的交叉反应性抗病毒IgA反应。 参见Overton 2014 https://www.sciencedirect.com/science/article/pii/S0264410X14010457?via%3DihubIchinohe 2007 https://academic.oup.com/jid/article/196/9/1313/2191831 Ichinohe 2010 https://onlinelibrary.wiley.com/doi/abs/10.1002/jmv.21824

    安普利近具有能够增强人类对流感病毒的同源和异源菌株的粘膜IgA反应的独特能力,这有赖于在粘膜环境中,安普利近和病毒中存在的外源蛋白表位之间的相互作用。这种相互作用导致抗原表位随着分泌型IgAS-IgA)的产生而扩散至反应性较低的常见抗原,从而导致与较远相关的演化支,甚至是以前未遇到的病毒株产生非常广泛的交叉反应性。我们认为,这可能是“通用”疫苗的关键。

    与常见的肌内(IM)或皮下(SQ)方法相比,鼻腔内接种具有几个优势:1)中和抗体可以在呼吸道入口处(气道粘膜)产生而非全身,2)如有需要,可以自行接种疫苗,并且3)存在抗原表位扩散的可能性。我们建议的疫苗考虑到灭活的武汉冠状病毒——

    一种从病人体内分离出的类似的灭活病毒,与安普利近组合并经鼻内(IN)给药,可产生粘膜S-IgA反应,因此可能对其他冠状病毒,包括SARSMERS和人冠状病毒229ENL63OC43具有广泛的交叉反应性。我们认为,类似于我们在上述与Overton研究和Ichinohe / Hasegawa动物实验的链接中描述的在人类中获得的流感结果​​,这种潜在的通用冠状病毒疫苗不仅可以针对目前鉴定出的冠状病毒显示出抗病毒活性,而且还可以针对存在于野生动物种群中新型的冠状病毒,或者是现有冠状病毒的突变显示出抗病毒活性——它们在未来还有可能像SARSMERS和武汉冠状病毒一样感染人类。

    最后,从过去两年我们在免疫肿瘤学临床试验中使用安普利近的能力可知,人类对安普利近的安全性可以完全放心。到阶段3为止,在FDA批准的临床试验中,大约有10万人静脉注射(IV)了药剂,耐受性良好,这充分证明了其安全性。我们还完成了第1阶段的鼻内给药的安全试验,这将非常有助于为人类研制出一种通用的鼻内冠状病毒疫苗(Overton 2014,参见上面的链接)。安普利近已被批准用于大量临床试验(主要用于肿瘤学)和美国FDA的长期护理项目(ME/CFS),并且阿根廷共和国也已批准其上市(ME / CFS),另外它还在荷兰获准进行胰腺癌的早发治疗。我们的药物安普利近通常具有良好的耐受性,因此可以随时在中国或任何其他有足够受试者的站点进行武汉冠状病毒临床试验。

    这是我们团队过去六周的主要成果。 如上所述,我们已经提交了临时专利申请,以保护我们将安普利近用作这种最新的冠状病毒流行病的预防性药剂和疫苗的想法。我们等到提交专利申请后才详细讨论所做的工作和努力,以便最大程度地保护这些想法的专利。现在,我们开始寻求政府合作,以便在中国和其他受影响地区将安普利近作为预防性疗法和疫苗投入使用。

    我们相信,我们在这里开展的工作意义重大,尤其是在应对潜在的大规模流行病时显得更为重要,这符合AIM的企业座右铭:“免疫创造美好未来”

    愿一切安好!

    首席执行官

    Thomas K. Equels

    AIM ImmunoTech Inc.

    电话: (352) 448-7797

    www.AIMimmuno.com

    关于AIM ImmunoTech公司

    AIM ImmunoTech公司是一家免疫制药公司,专门从事治疗免疫疾病、病毒性疾病和多种癌症的疗法的研究和开发。AIM的主打产品包括阿根廷批准的药物rintatolimod(商品名安普利近®Rintamod®)和FDA批准的药物Alferon N Injection®。根据已发表的同行评审的临床前研究和临床试验结果,AIM认为安普利近®可能具有广谱抗病毒和抗癌特性。安普利近®的临床试验包括对肾癌、恶性黑色素瘤、结直肠癌、晚期复发性卵巢癌和三阴性转移性乳腺癌患者的研究。这些和其他潜在用途需要额外的临床试验,确认支持监管批准和额外资金所需的安全性和有效性数据。Rintatolimod是一种双链RNA,开发用于治疗全球重要的削弱免疫系统的疾病和失调。

    前瞻性声明

    该公司介绍中包含了1995年《私人证券诉讼改革法》所指的前瞻性陈述,诸如“可能”“将会”“预期”“计划”“预计”等词语和类似的表达(以及其他提及未来事件或情况的词语或表达) 旨在标识前瞻性陈述。这些声明涉及许多风险和不确定性。例如,需要进行大量的额外测试和试验才能确定安普利近是否能有效治疗人体内的武汉冠状病毒,但不能保证能成功。这份报告包含了许多研究成果,但不能保证未来的研究不会得出与参考研究报告不同的结论。请注意,担任本公司高管的某些医生是公司介绍中提及的一些较早研究的合著者。一般而言,关于公司与安普利近的合作活动,无法保证目前或计划中的试验是否会成功或产生有利的数据,而且试验受到许多因素的影响,包括缺乏监管机构的批准、缺乏研究药物或赞助其他试验的机构的优先次序变动。此外,许多因素可能导致计划的临床试验无法启动,包括缺乏监管批准或缺乏研究药物。即使这些临床试验得以启动,我们也无法保证临床研究会成功或产生任何有用的数据或需要额外的资金。本公司介绍中所载的任何前瞻性陈述仅在本报告之日起生效。我们不承诺更新任何前瞻性声明,以反映在此日期之后发生的事件或情况。本文稿并不会参考本网站所载的资料,只供参考之用。

    联系人:

    Crescendo Communications, LLC
    电话: 212-671-1021
    电子邮件: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    电话: 800-778-4042
    电子邮件: IR@aimimmuno.com

    资料来源: AIM ImmunoTech Inc

    View source version on accesswire.com:
    https://www.accesswire.com/576559/AIM-ImmunoTech

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  62. OCALA, FL / ACCESSWIRE / February 18, 2020 / AIM ImmunoTech (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided its stockholders with an update on its efforts to develop Ampligen as a protective therapeutic and a vaccine in the new coronavirus epidemic. Ampligen, the company's flagship drug, has a commercial approval in Argentina, early-access therapeutic approval in the Netherlands, and is in numerous FDA-authorized clinical trials in the United States. This letter provides a detailed scientific basis for why the company is moving forward in the important and volatile Wuhan coronavirus space. The text of the letter…

    OCALA, FL / ACCESSWIRE / February 18, 2020 / AIM ImmunoTech (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided its stockholders with an update on its efforts to develop Ampligen as a protective therapeutic and a vaccine in the new coronavirus epidemic. Ampligen, the company's flagship drug, has a commercial approval in Argentina, early-access therapeutic approval in the Netherlands, and is in numerous FDA-authorized clinical trials in the United States. This letter provides a detailed scientific basis for why the company is moving forward in the important and volatile Wuhan coronavirus space. The text of the letter is set forth below and also is available on the company's website.

    Dear Valued Stockholder:

    As you know, our primary focus over the past two years has been on Ampligen (rintatolimod) in immuno-oncology. That remains our top priority. Nevertheless, mankind is faced with its third emerging highly pathogenic and deadly human coronaviral threat in less than two decades. We are referring to the lethal Wuhan Coronavirus, in which the disease is technically known as COVID-19 (Coronavirus disease-2019), in which the first cases were observed in Wuhan, China, only two months ago. Today there are more than 60,000 cases with well over 1,000 confirmed deaths. This virus thrives in hospital-like settings. In a recent study of infections contracted in hospitals, there was a 4.3% mortality rate (https://jamanetwork.com/journals/jama/fullarticle/2761044). The urgency of the situation only increases day by day, and any mutation which increases mortality would have major global consequences in a pandemic. It is for this reason that I directed the AIM ImmunoTech team to reexamine the antiviral properties of Ampligen in conjunction with the known genomic properties of the Wuhan coronavirus and its clinical syndrome, and the potential of Ampligen to serve as a protective therapeutic in such high-risk environments.

    To date, we have as step one developed the ideas behind our potential Wuhan outbreak therapy and vaccine. Next, we filed provisional Ampligen patent applications related to the Wuhan coronavirus (see: https://aimimmuno.irpass.com/AIM-ImmunoTech-Files-Three-Provisional-Patent-Applications-Surrounding-AmpligenR-for-Use-Against-the-SARS-like-Wuhan-2019-Novel-Coronavirus). Now, we are moving aggressively to bring our findings to the governments of the U.S., China and Japan.

    When the Wuhan coronavirus outbreak first emerged, our AIM ImmunoTech team went to work immediately. Our drug Ampligen had excellent antiviral activity against the coronavirus SARS in U.S. National Institutes of Health (NIH)-contracted animal experiments, conferring 100% protective survival.

    In the Day 2009 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787736/) and Barnard 2006 (https://journals.sagepub.com/doi/abs/10.1177/095632020601700505) NIH studies of SARS-infected mice, Ampligen stood out as the only drug conferring a significant antiviral/survival effect. We knew, if the Wuhan virus shared key genomic and pathogenic similarities with SARS, we may have important insight into developing a potential protective early-onset therapy for this new lethal virus where currently there is no effective therapy. Again, the Wuhan coronavirus is especially virulent in hospital and institutional quarantine settings, so such prophylactic protective measures may help blunt the spread of the disease.

    Rapidly, we obtained genomic RNA sequences of the new virus and compared them to the SARS virus' RNA sequences. As you will see in the section following the synopsis of the SARS experimentation with Ampligen in animals, the RNA sequences of the SARS virus in key areas of viral replication are almost identical for the Wuhan coronavirus. Therefore, we believe it is very likely that Ampligen would have similar antiviral activity against the Wuhan coronavirus as it did against the SARS-CoV. These experimental evaluations of Ampligen as an antiviral treatment for SARS took place after the last SARS outbreak about 15 years ago. At that time, Ampligen was the only therapy which, in the NIH-contracted animal experiment, conferred significant efficacy, up to 100% survival as compared to 100% mortality in the SARS infected control group. In these two studies (Barnard 2006 and Day 2009), SARS mouse models were evaluated and the Ampligen dose utilized in these studies yielded antiviral and survival effects, i.e. reduction of SARS virus lung titers below the level of detection (Barnard 2006) and increased survival (Day 2009). Importantly, these effects were obtained at clinically achievable/tolerated human dosage levels. Ampligen was the only drug active at clinically achievable serum/dosage levels (Strayer 2014 http://www.eurekaselect.com/123324/article). Barnard (2006) studied the ability of Ampligen and rIFN-αB/D to inhibit SARS virus (Urbani Strain) titers in the lungs of BALB/c mice. Complete inhibition to below detectable levels was seen with Ampligen at 10 mg/kg which is equivalent to 700 mg in an average weight human (70 kg) and has also been shown to be a generally well-tolerated dosage level (Thompson 1996 https://www.ncbi.nlm.nih.gov/pubmed/8874076). The rIFN-α B/D inhibited virus titers to below detectable level, but required a dose of 100,000 IU in mice, which is equivalent to an extremely high human dose of 500 x 106 IU, and furthermore is not clinically available. Day (2009) studied a new mouse-adapted strain of SARS-CoV as a lethal model. Only Ampligen at a dosage of 10 mg/kg/day obtained a 100% survival rate.

    In summary, only Ampligen showed any significant response when evaluating protection and survival (Day 2009, Barnard 2006 and Strayer 2014). The above SARS-related experiments indicate that, unlike other drugs, Ampligen has a significant positive prophylactic early-onset therapeutic effect. Further, Ampligen has demonstrated significant synergy when combined with otherwise marginally effective antivirals to enhance antiviral therapy programs in other viruses. While there is currently no therapy for the Wuhan coronavirus, if a future traditional-based antiviral therapy is developed for this coronavirus, we believe that the combination of traditional antiviral therapies and Ampligen may produce a synergistic effect similar to what we have seen with Ampligen in other viruses that serves to improve performance, because Ampligen's immunological mechanism of action is both different and complementary to the typical antiviral. (See: "Ampligen as an Antiviral," slides 46-50, at https://aimimmuno.com/events-presentations/).

    We believe the significant similarity of the Wuhan coronavirus to SARS suggests Ampligen has a high probability of a similar potential efficacy against the Wuhan coronavirus. Our analysis comparing key transcription regulatory sequences of SARS to the Wuhan coronavirus wherein we analyzed the similarity between SARS-CoV and the Wuhan coronavirus found significant and compelling similarities. Our results are listed in Table 1 and discussed below. These similarities among the analyzed sequences suggest possible extension of the antiviral effects of Ampligen seen in SARS experiments to that of Wuhan coronavirus. We provide this extra detail for those of you who are interested in a deeper analysis - however, the short story is that we have a remarkable 99% similarity in these key areas.

    Coronavirus replication uses a unique transcription mechanism for the creation of nested sets of mRNAs. Selection of the correct reading frame for each mRNA is provided by transcription-regulating sequences (TRSs). Our comparison of the TRS (transcription regulatory sequences) of the first five open-reading frames (ORF) of SARS-CoV identified by Mara (2003) (https://science.sciencemag.org/content/300/5624/1399.long) to the Wuhan coronavirus responsible for COVID-19 is shown below in Table 1.

    Table 1. TRS sequence comparison of two Highly Pathogenic Human Coronaviruses (HPHuCoV)

    HPHuCoV

    Base

    ORF*

    TRS Sequence**

    SARS

    Wuhan

    60

    63

    Leader

    UCUCUAAACGAACUUUAAAAUCUGUG

    UCUCUAAACGAACUUUAAAAUCUGUG

    SARS

    Wuhan

    21,479

    21,549

    S (spike)

    CAACUAAACGAAC

    CAACUAAACGAAC

    SARS

    Wuhan-

    25,252

    25,378

    ORF3

    CACAUAAACGAACUU

    CACAUAAACGAACUU

    SARS

    Wuhan

    26,104

    26,232

    Envelope

    UGAGUACGAACUU

    UGAGUACGAACUU

    SARS

    Wuhan

    26,341

    26,466

    M

    GGUCUAAACGAACUAACU

    GGUCUAAACGAACUAAAU

    *Open Reading Frame (i.e.-encodes for a protein)

    **Marra, et al. https://science.sciencemag.org/content/300/5624/1399.long

    We see that the TRS for the first five ORFs for the SARS-CoV (Tor2) compared to the Wuhan-CoV virus recently isolated from a patient with a SARS-like illness in China is identical with the exception of a single nucleotide (C/A) for the Membrane (M) coronavirus protein. Thus, four of the five TRS sequences (Leader, S (spike), ORF3, and Envelope) are identical for the SARS-CoV compared to the Wuhan-CoV isolate. The M protein has a single nucleotide change: the A in the SARS-CoV is changed to a C in the Wuhan-CoV. Thus, the TRS sequences of these two coronaviruses are almost identical with 84/85 nucleotides the same (99% homology).

    An important pathogenic feature of SARS-CoV disease and COVID-19 is that they both utilize the same ACE2 receptor to bind to and infect a human cell. This ACE2 receptor similarity, along with the similarity of the analyzed key regulatory viral genomic sequences show, with reasonable probability, that the functional effects of Ampligen in these SARS experiments will likely extend to the Wuhan coronavirus. This is important because no effective protective therapy currently exists for a disease that is demonstrating high levels of nosocomial transmissibility - which means you easily catch it in hospital-like settings. This virus thrives in hospital-like settings. That means health care workers and exposed persons desperately need an effective protective early-onset therapeutic.

    In addition to Ampligen as an antiviral, we have developed a vaccine concept, which would utilize an inactivated Wuhan/coronavirus vaccine plus Ampligen to create a vaccine that would likely immunize against the specific viral targets and would also confer cross-protection against mutations of the coronavirus and other similar coronaviruses, potentially creating, in effect, a potential universal coronavirus vaccine.

    Influenza presents a meaningful analogy. The AIM-sponsored clinical results in humans seen in the Overton (2014) paper and the Ichinohe/Hasegawa (2007 and 2010) experimental results in mice and monkeys as stated in the papers show how, in influenza, Ampligen as a double-stranded RNA (dsRNA) and a generally well-tolerated selective toll-like receptor 3 (TLR3) agonist with induction of innate and adaptive immune responses has a powerful immunological impact on a vaccine's activity in mice, non-human primates and humans showing evidence of epitope spreading and cross-protection/cross-reactivity. TLR3 is expressed in high concentrations on human airway epithelial cells and serves as a recognition system initiating innate and subsequent adaptive immune responses for many respiratory pathogens.

    The mucosal surface of the nose and respiratory tract serve as an ideal environment for Ampligen, as a TLR3 agonist, to exert its pronounced ability to enhance the innate and adaptive immune responses to respiratory pathogens such as influenza virus, adenovirus, and coronavirus. Indeed the intranasal instillation of inactivated or attenuated influenza viruses contained in seasonal influenza vaccination, when used in combination with Ampligen, has been shown to be able to induce a broad cross-reactivity antiviral IgA response to influenza viruses highly pathogenic to humans, such as various H5N1 clades (A/Indonesia/5/2000, A/HongKong/483/97, and A/Vietnam/1194/2004) in mice, non-human primates, and humans. See Overton 2014 https://www.sciencedirect.com/science/article/pii/S0264410X14010457?via%3Dihub, Ichinohe 2007 https://academic.oup.com/jid/article/196/9/1313/2191831, and Ichinohe 2010 https://onlinelibrary.wiley.com/doi/abs/10.1002/jmv.21824)

    The unique ability of Ampligen to be able to enhance in humans the mucosal IgA response to both homologous and heterologous strains of influenza virus is dependent on the interaction at the mucosal environment with Ampligen and the foreign protein epitopes present in the viruses. This interaction results in epitope spreading to less responsive common antigens with the generation of secretory IgA (S-IgA) resulting in a very broad cross-reactivity against more distantly related clades and even strains of viruses not previously encountered. We believe this may be the key to a "universal" vaccine.

    The use of intranasal vaccination for respiratory viral pathogens has several advantages over standard intramuscular (IM) or subcutaneous (SQ) approaches: 1) neutralizing antibodies can be generated at the point of respiratory entrance- the airway mucosa rather than systemic, 2) vaccination could be self-administered if required, and 3) there is the potential of epitope spreading. Our proposed vaccine contemplates inactivated Wuhan-CoV, a similar inactivated isolated virus from patients, or an antigen thereof, combined with Ampligen and administered intranasally (IN), with the generation of a mucosal S-IgA response and consequently having potentially a broad cross-reactivity against other coronaviruses, including SARS, MERS, and the Human Coronaviruses 229E, NL63, and OC43. We believe, similar to the influenza results we obtained in humans described in the above link to the Overton study and the Ichinohe/Hasegawa animal experiments, that this potentially universal coronavirus vaccine may demonstrate antiviral activity not only against currently identified coronaviruses, but also against newly emerging coronaviruses resident in wild animal populations with the potential to emerge in the future to infect human populations similarly to SARS, MERS, and Wuhan CoV, or mutations from existing coronaviruses.

    Finally, as you know from our ability to deploy Ampligen in immuno-oncology clinical trials over the past two years, Ampligen has a well-developed safety profile for human use. Our safety profile involves approximately 100,000 generally well-tolerated intravenous (IV) doses in humans in FDA authorized clinical trials up through Phase 3. We have also completed a Phase 1 safety trial for intranasal administration of Ampligen, which would be highly advantageous to creating a universal intranasal coronavirus vaccine for humans (Overton 2014, see link above). Ampligen has been authorized for use in humans in numerous ongoing clinical trials (primarily in oncology) and in a long-term compassionate care program (ME/CFS) by the U.S. FDA. Ampligen has received full commercial approval (ME/CFS) from the Republic of Argentina. Ampligen has an early access use approval for use in pancreatic cancer from the Netherlands. Our drug Ampligen is generally well-tolerated, which makes it primed and ready for Wuhan coronavirus clinical trials in China or any other site with sufficient subjects.

    This has been a major effort for our team over the past six weeks. As noted above, we have filed provisional patent applications to protect our ideas in applying Ampligen as a protective therapeutic and a vaccine in this newest coronavirus epidemic. We waited until our patent applications were filed to discuss in detail our efforts, so as to protect the rights to these ideas to the greatest extent possible. Now we begin the process of seeking government partners to develop Ampligen as both a protective therapy and a vaccine in China and other affected areas.

    We believe our work here is very important and, especially when dealing with a potential pandemic, consistent with AIM's corporate motto: "Immunology for a better future."

    All the best,

    Thomas K. Equels, CEO

    AIM ImmunoTech Inc.
    Tel: (352) 448-7797
    www.AIMimmuno.com

    About AIM ImmunoTech Inc

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of the Wuhan Coronavirus in humans and no assurance can be given that it will be the case. The press release references a number of studies. No assurance can be given that future studies will not result in findings that are different from those reported in the referenced studies. The filing of provisional patent applications provides no assurance that patents will ultimately be granted. The Company will be reaching out to numerous foreign governments and, if successful, will be working in these countries. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential operations in foreign countries will not be adversely affected by these risks. Please note that certain doctors who were executives of the Company were co-authors of some of the studies referenced herein. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc

    View source version on accesswire.com:
    https://www.accesswire.com/576559/AIM-ImmunoTech-Issues-Stockholder-Update-on-the-Potential-Role-of-Ampligen-for-Use-Against-the-Wuhan-Coronavirus-Epidemic

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  63. 在針對SARS的動物實驗中,安普利近® 在臨床可達到的人體劑量水平下實現了100%的存活率
    安普利近是開發中的廣譜通用冠狀病毒疫苗的關鍵
    奧卡拉,佛羅里達州, 2020年2月11日 - (亞太商訊) - AIM ImmunoTech公司(NYSE-American交易代碼:AIM)今天宣布提交了三份臨時專利申請,涉及其候選藥物安普利近,這是公司加入全球衛生界抗擊致命的武漢冠狀病毒的努力,該病毒迄今為止已經感染了大約40000人,有近千人死亡,主要集中在中國。

    安普利近,強大的實驗免疫系統調節劑。

    冠狀病毒是一大類病毒,包括致命的嚴重急性呼吸綜合徵 (SARS)。在2002年於中國南方廣東省爆發的SARS疫情造成8000多例病例和800多人死亡後,美國國立衛生研究院委託開展了一項研究,以評估SARS的潛在治療方法。在動物實驗中,安普利近在臨床可達到的人體劑量水平下實現了100%的存活率,這與100%的死亡率相比形成鮮明對比。 SARS病毒的關鍵RNA序列與武漢冠狀病毒非常相似,該公司預計安普利近對武漢冠狀病毒也有類似的效果。

    AIM是一家專注於研究和開發治療免疫疾病、病毒性疾病和多種癌症療法的免疫製藥公司,已將重點放在為主要受該流行病影響的國家提供該公司的安普利近技術。

    AIM相信,安普利近有可能被用於武漢冠狀病毒的早發治療和預防,該病毒起源於中國,然後迅速蔓延到其他國家。該公司的三項臨時專利申請包括:1) 使用安普利近來治療武漢冠狀病毒;2) 將安普利近用作開發中的鼻內通用冠狀病毒疫苗的一部分,這將安普利近與已滅活的武漢冠狀病毒結合來輸送免疫並提供交叉保護;3) 安普利近的批量生產工藝。依照對專利提供國際保護的1970年《專利合作條約》,這三項臨時專利申請可以根據申請日期轉換為國際專利申請。或者,根據1883年《保護工業產權巴黎公約》(一項國際協定),可以在許多國家直接提交國家申請。作為這一流行病的中心,中國是該條約和協定的簽署國…

    在針對SARS的動物實驗中,安普利近® 在臨床可達到的人體劑量水平下實現了100%的存活率
    安普利近是開發中的廣譜通用冠狀病毒疫苗的關鍵
    奧卡拉,佛羅里達州, 2020年2月11日 - (亞太商訊) - AIM ImmunoTech公司(NYSE-American交易代碼:AIM)今天宣布提交了三份臨時專利申請,涉及其候選藥物安普利近,這是公司加入全球衛生界抗擊致命的武漢冠狀病毒的努力,該病毒迄今為止已經感染了大約40000人,有近千人死亡,主要集中在中國。

    安普利近,強大的實驗免疫系統調節劑。

    冠狀病毒是一大類病毒,包括致命的嚴重急性呼吸綜合徵 (SARS)。在2002年於中國南方廣東省爆發的SARS疫情造成8000多例病例和800多人死亡後,美國國立衛生研究院委託開展了一項研究,以評估SARS的潛在治療方法。在動物實驗中,安普利近在臨床可達到的人體劑量水平下實現了100%的存活率,這與100%的死亡率相比形成鮮明對比。 SARS病毒的關鍵RNA序列與武漢冠狀病毒非常相似,該公司預計安普利近對武漢冠狀病毒也有類似的效果。

    AIM是一家專注於研究和開發治療免疫疾病、病毒性疾病和多種癌症療法的免疫製藥公司,已將重點放在為主要受該流行病影響的國家提供該公司的安普利近技術。

    AIM相信,安普利近有可能被用於武漢冠狀病毒的早發治療和預防,該病毒起源於中國,然後迅速蔓延到其他國家。該公司的三項臨時專利申請包括:1) 使用安普利近來治療武漢冠狀病毒;2) 將安普利近用作開發中的鼻內通用冠狀病毒疫苗的一部分,這將安普利近與已滅活的武漢冠狀病毒結合來輸送免疫並提供交叉保護;3) 安普利近的批量生產工藝。依照對專利提供國際保護的1970年《專利合作條約》,這三項臨時專利申請可以根據申請日期轉換為國際專利申請。或者,根據1883年《保護工業產權巴黎公約》(一項國際協定),可以在許多國家直接提交國家申請。作為這一流行病的中心,中國是該條約和協定的簽署國。

    “憑藉對SARS病毒和武漢冠狀病毒RNA序列的分析及研究工作,AIM相信安普利近對這種新的致命病毒的早發治療和預防具有顯著的治療潛力,”AIM首席執行官Thomas K. Equels說。 “如果臨床試驗與SARS動物試驗的結果相同,則這意味著幫助那些已經患病的人,為直接接觸病毒傳播的人提供預防,這對遏制全球突發事件的類似醫院環境的醫療專業人員,以及那些被隔離在營地和遊輪上的人來說尤為重要。AIM的通用冠狀病毒疫苗概念主要是為了接種預防武漢冠狀病毒,但通過安普利近的獨特功能,它還可以防止其他形式的冠狀病毒和武漢冠狀病毒未來的突變。AIM是一家小型免疫研究公司,但我們想儘自己的一份力量。我們認為,人類必須團結起來,戰勝這種病毒威脅。這是我們為改變武漢冠狀病毒造成的全球威脅所作的努力。”

    安普利近是唯一基於合成雙鏈RNA的已知特異性Toll樣受體3激動劑,具有良好的靜脈、腹腔和鼻腔安全性,同時顯示出對廣譜病毒的強大抗病毒活性。該藥物也被用於多個正在進行的免疫腫瘤學臨床研究。 AIM最近生產了超過10000瓶的安普利近。

    關於AIM ImmunoTech公司
    AIM ImmunoTech公司是一家免疫製藥公司,專門從事治療免疫疾病、病毒性疾病和多種癌症的療法的研究和開發。 AIM的主打產品包括阿根廷批准的藥物rintatolimod(商品名安普利近®或Rintamod®)和FDA批准的藥物Alferon N Injection®。根據已發表的同行評審的臨床前研究和臨床試驗結果,AIM認為安普利近®可能具有廣譜抗病毒和抗癌特性。安普利近®的臨床試驗包括對腎癌、惡性黑色素瘤、結直腸癌、晚期復發性卵巢癌和三陰性轉移性乳腺癌患者的研究。這些和其他潛在用途需要額外的臨床試驗,確認支持監管批准和額外資金所需的安全性和有效性數據。 Rintatolimod是一種雙鏈RNA,開髮用於治療全球重要的削弱免疫系統的疾病和失調。

    警告性聲明
    本新聞稿中的一些聲明可能是前瞻性聲明,涉及許多風險和不確定性。例如,提交臨時專利申請並不能保證最終會授予專利。無法保證將來與此有關的任何臨床試驗。無法保證目前或計劃中的試驗是否會成功或產生有利的數據,而且試驗受到許多因素的影響,包括缺乏監管機構的批准、缺乏研究藥物或贊助其他試驗的機構的優先次序變動。此外,許多因素可能導致計劃的臨床試驗無法啟動,包括缺乏監管批准或缺乏研究藥物。即使這些臨床試驗得以啟動,我們也無法保證臨床研究會成功或產生任何有用的數據或需要額外的資金。此外,對於前瞻性陳述,我們要求保護1995年《私人證券訴訟改革法》中所載前瞻性陳述的安全港。本新聞稿中的任何前瞻性聲明僅在本新聞稿發布之日起生效。我們不承諾更新任何前瞻性聲明,以反映在此日期之後發生的事件或情況。可在www.aimmino.com上獲取本新聞稿和早期的版本。本新聞稿並不會參考本網站所載的資料,只供參考之用。

    聯繫人:
    Crescendo Communications, LLC
    電話: 212-671-1021
    電子郵件: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    電話: 800-778-4042
    電子郵件: IR@aimimmuno.com

    資料來源: AIM ImmunoTech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/575818/AIM-ImmunoTechR-SARS2019

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  64. OCALA, FL / ACCESSWIRE / February 12, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that its Chief Executive Officer, Thomas K. Equels, will appear live today as a guest on FOX Business Network's The Claman Coutdown and Cheddar's Opening Bell.

    Mr. Equels is scheduled to appear on Cheddar's Opening Bell with hosts Hope King and Nora Ali at 10:20 AM ET. Mr. Equels will also appear on The Claman Countdown on the FOX Business Network with host Liz Claman between 3 PM and 4 PM ET.

    Mr. Equels plans to discuss the therapeutic potential of Ampligen as both an early-onset treatment for and…

    OCALA, FL / ACCESSWIRE / February 12, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that its Chief Executive Officer, Thomas K. Equels, will appear live today as a guest on FOX Business Network's The Claman Coutdown and Cheddar's Opening Bell.

    Mr. Equels is scheduled to appear on Cheddar's Opening Bell with hosts Hope King and Nora Ali at 10:20 AM ET. Mr. Equels will also appear on The Claman Countdown on the FOX Business Network with host Liz Claman between 3 PM and 4 PM ET.

    Mr. Equels plans to discuss the therapeutic potential of Ampligen as both an early-onset treatment for and prophylaxis against the Wuhan coronavirus that has so far infected approximately 40,000 people and is now responsible for more deaths than the original highly pathogenic human coronavirus (SARS). Due to Ampligen's unique immune stimulation capabilities based on peer reviewed and published animal and human studies on influenza, a vaccine created by combining Ampligen and inactivated Wuhan coronavirus could potentially protect against other forms of coronavirus and future mutations of the Wuhan coronavirus.

    Coronaviruses are a large family of viruses, including the deadly Severe Acute Respiratory Syndrome (SARS). After a 2002 SARS outbreak in the Guangdong province of southern China caused more than 8,000 cases and more than 800 deaths, the United States' National Institutes of Health contracted studies to evaluate potential treatments for SARS. Ampligen achieved a 100% survival rate - as compared to 100% mortality - at clinically achievable human dosage levels in SARS animal experiments.

    Ampligen has generated a generally well-tolerated safety profile based on approximately 100,000 IV doses in human clinical trials to date, as well as Phase 1 safety studies in intraperitoneal (IP) and intranasal (IN) administration.

    About Cheddar

    Cheddar is the leading post-cable news, media, and entertainment company. Cheddar broadcasts live on SlingTV, Hulu Live, YouTube TV, Philo, Twitter, Facebook Watch, Pluto, Xumo and more. Watched live by more than 6.5M people each month, Cheddar also garners hundreds of millions of organic video views monthly across Facebook, YouTube, Twitter, Snapchat, Instagram, LinkedIn and other social & distributed video platforms. Cheddar currently broadcasts two live video news networks: Cheddar, a business news network covering the most innovative executives, founders, products, and technologies transforming our lives and economy; and Cheddar News, a fast-paced, young, non-partisan general news and headline news network. The company broadcasts from the trading floor of the New York Stock Exchange.

    About The Claman Countdown

    The Claman Countdown is a financial news program airing on the Fox Business Network from 3-4pm ET. Hosted by Liz Claman, this program covers the final hour of trading on Wall Street.

    About AIM ImmunoTech Inc

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    Some of the statements included in this press release and that may be made in the Cheddar and FOX interviews may be forward-looking statements that involve a number of risks and uncertainties. For example, the filing of provisional patent applications provides no assurance that patents will ultimately be granted. No assurance can be made as to any future clinical trials related to the matter herein. No assurance can be given as to whether the current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/576151/AIM-ImmunoTechs-CEO-to-Appear-Live-Today-on-FOX-Business-Networks-The-Claman-Countdown-and-Cheddars-Opening-Bell-to-Discuss-the-Potential-Role-of-AmpligenR-for-Use-Against-the-Wuhan-2019-Novel-Coronavirus

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  65. Ampligen® obtained 100% survival rate at clinically achievable human dosage levels for SARS in animal experiments

    Ampligen key to proposed broad-spectrum 'universal' coronavirus vaccine

    OCALA, FL / ACCESSWIRE / February 11, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced the filing of three provisional patent applications related to its drug candidate Ampligen in the company's efforts toward joining the global health community in the fight against the deadly Wuhan coronavirus that has so far infected approximately 40,000 people and killed almost one thousand, primarily in China.

    Coronaviruses are a large family of viruses, including the deadly Severe Acute Respiratory Syndrome (SARS). After a 2002 SARS outbreak in the Guangdong province…

    Ampligen® obtained 100% survival rate at clinically achievable human dosage levels for SARS in animal experiments

    Ampligen key to proposed broad-spectrum 'universal' coronavirus vaccine

    OCALA, FL / ACCESSWIRE / February 11, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) today announced the filing of three provisional patent applications related to its drug candidate Ampligen in the company's efforts toward joining the global health community in the fight against the deadly Wuhan coronavirus that has so far infected approximately 40,000 people and killed almost one thousand, primarily in China.

    Coronaviruses are a large family of viruses, including the deadly Severe Acute Respiratory Syndrome (SARS). After a 2002 SARS outbreak in the Guangdong province of southern China caused more than 8,000 cases and more than 800 deaths, the United States' National Institutes of Health contracted studies to evaluate potential treatments for SARS. Ampligen achieved a 100% survival rate - as compared to 100% mortality - at clinically achievable human dosage levels in animal experiments. The SARS virus is very similar in key RNA sequences to the Wuhan coronavirus, and the company expects Ampligen to be similarly effective with the Wuhan coronavirus.


    Ampligen, a powerful experimental
    immune system modulator.

    AIM - which is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers - is already focused on avenues to provide the company's Ampligen technology to the countries primarily afflicted by the pandemic.

    AIM believes that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against the Wuhan coronavirus, which originated in China before quickly spreading to other countries. The company's three provisional patent applications include: 1) Ampligen as a therapy for the Wuhan coronavirus; 2) Ampligen as part of a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated Wuhan coronavirus, conveying immunity and cross-protection and; 3) a high-volume manufacturing process for Ampligen. Under the Patent Cooperation Treaty of 1970, which provides international protections for patents, the three provisional patent applications can convert to international patent applications based on the date of their filings. Alternatively, direct national filings in many countries are possible under the Paris Convention for the Protection of Industrial Property of 1883 - an international agreement. China, the epicenter of the epidemic, is a signatory of both the treaty and the agreement.

    "Our analysis of the RNA sequences of the SARS virus and the Wuhan coronavirus and our research lead AIM to believe Ampligen has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus," said AIM CEO Thomas K. Equels. "If clinical trials follow the results of SARS animal testing, this means helping people who are already sick as well as a prophylaxis for people directly exposed to the virus as it spreads, which is especially important for the medical professionals in hospital-like settings working to contain the global emergency, and those people quarantined in camps and on cruise ships. AIM's universal coronavirus vaccine concept is primarily meant to inoculate against the Wuhan coronavirus, but, through Ampligen's unique capabilities, could also protect against other forms of coronavirus and future mutations of the Wuhan coronavirus. AIM is a small immunological research company, but we want to do our part. We believe humanity must stand together to defeat such viral threats. This is our effort to make a difference in this worldwide threat posed by the Wuhan coronavirus."

    Ampligen is the only known specific Toll-Like Receptor 3 agonist based on synthetic double-stranded RNA with a well-developed intravenous, intraperitoneal and intranasal safety profile while demonstrating strong antiviral activity against a broad spectrum of viruses. The drug is also being used in multiple ongoing immuno-oncology clinical studies. AIM has recently produced more than 10,000 vials of Ampligen.

    About AIM ImmunoTech Inc

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Cautionary Statement

    Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For example, the filing of provisional patent applications provides no assurance that patents will ultimately be granted. No assurance can be made as to any future clinical trials related to the matter herein. No assurance can be given as to whether the current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email: aim@crescendo-ir.com

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email: IR@aimimmuno.com

    SOURCE: AIM ImmunoTech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/575818/AIM-ImmunoTech-Files-Three-Provisional-Patent-Applications-Surrounding-AmpligenR-for-Use-Against-the-SARS-like-Wuhan-2019-Novel-Coronavirus

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  66. OCALA, FL / ACCESSWIRE / February 5, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, today announced posting by the University of Pittsburgh Medical Center (UPMC) on January 28, 2020 via ClinicalTrials.gov of completion of an independent, third-party clinical trial to evaluate the safety and activity of a triple combination (chemokine modulatory regimen or CKM) of celecoxib, interferon alfa (IFN), and Ampligen (rintatolimod), given with a dendritic cell (DC) vaccine, as a potential treatment for metastatic peritoneal surface malignancies after standard of care surgery.

    The principal investigator of the trial was David L. Bartlett, MD…

    OCALA, FL / ACCESSWIRE / February 5, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, today announced posting by the University of Pittsburgh Medical Center (UPMC) on January 28, 2020 via ClinicalTrials.gov of completion of an independent, third-party clinical trial to evaluate the safety and activity of a triple combination (chemokine modulatory regimen or CKM) of celecoxib, interferon alfa (IFN), and Ampligen (rintatolimod), given with a dendritic cell (DC) vaccine, as a potential treatment for metastatic peritoneal surface malignancies after standard of care surgery.

    The principal investigator of the trial was David L. Bartlett, MD, an internationally recognized cancer researcher at UPMC, in collaboration with the National Cancer Institute. Detailed analysis of the clinical data by the investigators is expected to be reported by publication. For more information on the results, including limitations of the clinical trial, which according to the filing saw a median survival rate of 52 months for the 64 patients treated in the study, please visit: https://clinicaltrials.gov/ct2/show/study/NCT02151448.

    "We were honored to have Ampligen included in this trial and believe the outcome of this trial will be informative given the growing body of evidence supporting the important role Ampligen may play in modulating the immune system in oncology," said AIM ImmunoTech CEO Thomas K. Equels. "Ampligen is a broadly applicable immune therapy that has the potential to be used in a wide range of therapies with a generally well-tolerated safety profile based on approximately 100,000 IV doses in humans to date, as well as Phase 1 safety studies in intraperitoneal (IP) and intranasal (IN) administration. Ampligen is als