AIM AIM ImmunoTech Inc.

2.48
+0.05  (+2%)
Previous Close 2.43
Open 2.55
52 Week Low 0.381
52 Week High 7.11
Market Cap $80,858,995
Shares 32,624,166
Float 2,304,903
Enterprise Value $130,562,439
Volume 3,411,104
Av. Daily Volume 4,048,771
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Upcoming Catalysts

Drug Stage Catalyst Date
Ampligen, Intron A, and celecoxib
Colorectal cancer
Phase 2
Phase 2
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Ampligen, Intron A, celecoxib and pembrolizumab
Triple-Negative Breast Cancer
Phase 1
Phase 1
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Ampligen plus Intron A
Ovarian cancer
Phase 1/2
Phase 1/2
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Ampligen, cisplatin and pembrolizumab
Ovarian cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Ampligen, Intron A
Prostate Cancer
Phase 2
Phase 2
Phase 2 trial to commence enrolment in 4Q 2019.
Ampligen
CFS
CRL
CRL
CRL February 4, 2013.

Latest News

  1. 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 ImmunoTech Inc
    Phone: 800-778-4042
    Email:

    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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  2. 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:

    SOURCE: AIM ImmunoTech Inc.



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

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  3. 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 ImmunoTech Inc
    Phone: 800-778-4042
    Email:

    SOURCE: AIM ImmunoTech Inc



    View source version on accesswire.com:
    https://www.accesswire.com/593872/AIM-ImmunoTech-Provides-Update-on-Commercial-Launch-of-AmpligenR-in-Argentina-for-the-Treatment-of-Chronic-Fatigue-Syndrome

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  4. 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 ImmunoTech Inc
    Phone: 800-778-4042
    Email:

    SOURCE: AIM ImmunoTech Inc



    View source version on accesswire.com:
    https://www.accesswire.com/593571/AIM-ImmunoTech-Files-Provisional-Patent-Application-for-the-Use-of-AmpligenR-as-a-Potential-Therapy-for-COVID-19-Induced-Chronic-Fatigue

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  5. 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 ImmunoTech Inc
    Phone: 800-778-4042
    Email:

    SOURCE: AIM ImmunoTech Inc

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    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

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