CYDY Cytodyn Inc
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Leronlimab
COVID-19 (Mild to Moderate)
|
Phase 2
Phase 2
|
Phase 2 data released August 11, 2020 did not report primary endpoint data (TCSS at Day 14). Day 3 subgroup showed clinical improvement but not mentioned to be statistically significant. Secondary NEWS2 was met. No data on other secondary endpoints.
|
|
Leronlimab
COVID-19 (critically ill)
|
Phase 2/3
Phase 2/3
|
Phase 3 trial to continue as planned following DSMB safety review. Interim analysis likely due 2H 2020.
|
|
Leronlimab (PRO 140)
HIV
|
BLA Filing
BLA Filing
|
Refusal to file letter announced July 13, 2020.
|
|
Leronlimab (PRO 140)
Triple Negative Breast Cancer
|
Phase 1/2
Phase 1/2
|
Phase 1/2 trial ongoing.
|
|
Leronlimab
Non-alcoholic steatohepatitis (NASH)
|
Phase 2
Phase 2
|
Phase 2 initiation announced June 11, 2020.
|
Latest News
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VANCOUVER, Washington, Oct. 26, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government has cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in the U.K.
The MHRA's clearance for the BLA filing included a treatment regimen of one injection per week of 350 mg of the Company's product leronlimab, as contrasted to the dosage used in the Phase 3 clinical trial conducted in the U.S. for this indication of two consecutive injections of 175 mg per week. During a recent 2-hour meeting between the CytoDyn BLA team and the MHRA, the parties discussed in detail the primary components of the BLA filing: non-clinical, clinical and manufacturing. In connection with the manufacturing section, the Company confirmed it had the necessary one-year of stability data for a 350 mg dose of leronlimab for patients in need of this treatment.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, "We are very pleased with the MHRA's decision to clear our BLA for filing and our team is finalizing the remaining details to ensure a complete filing very soon. We hope to receive notice of acceptance within two weeks of our filing. The MHRA also had questions about CytoDyn's recent COVID-19 Phase 3 severe-to-critical population interim analysis. We are very excited with all of the opportunities we are able to explore for leronlimab's potential indication in the U.S. and abroad. Should CytoDyn receive approval in the U.K. for HIV combination therapy, we will follow up immediately with a label expansion of monotherapy in U.K."
About Leronlimab's Ability to Cross Blood-Brain Barrier
The blood-brain barrier (BBB) mediates the communication between the periphery and the central nervous system (CNS). The BBB separates the circulation from the brain. It is a highly selective permeable border of endothelial cells and acts as a metabolic barrier, transport interface, and secretory body. The BBB prevents solutes in the circulating blood from non-selectively crossing into the central nervous system's extracellular fluid where neurons reside. The blood vessels that vascularize the central nervous system (CNS) possess unique functions. The BBB allows precise control of CNS homeostasis. It serves to allow for proper neuronal function and also protects the neural tissue from toxins and pathogens. Alterations of these barrier properties are an important component of central nervous system diseases.An important recent discovery of leronlimab is the ability to cross the blood-brain barrier to treat diseases where CCR5 antagonism may benefit the central nervous system. In a study of HIV in macaques, it was determined that the administration of leronlimab resulted in approximately 70-75% CCR5 receptor occupancy in the frontal lobes, parietal lobes, and cerebellum. Independent research on CCR5 antagonism in central nervous system pathology has shown promise in various disease processes, including multiple sclerosis, Parkinson's disease, CNS tumors, traumatic brain injury, and stroke recovery.
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.CytoDyn is currently conducting its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in numerous hospitals and clinics across the U.S., which are identified on the Company's website under the "Clinical Trial Enrollment" section of the homepage.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company's questions concerning its recent Biologics License Application ("BLA") for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
[email protected]
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VANCOUVER, Washington, Oct. 26, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today two patients have demonstrated noticeable signs of improvement following treatment with leronlimab (PRO 140) in helping their recovery from stroke.
The most recent stroke patient, a physician in Mississippi, requested leronlimab, which was administered to him under Mississippi's recently expanded "Right to Try" statute. The physician's son, commenting on his father, stated, "He is doing good. Yesterday, he received his second treatment. He said he has been feeling better, and he thinks it is working. He said parts of his body and face that have been numb are starting to change/wake up."
Scott A. Kelly, M.D., CytoDyn Chairman of the Board, Chief Medical Officer and Head of Business Development, commented, "We are encouraged by leronlimab's potential to help patients recover from stroke and traumatic brain injury. Independent research has concluded CCR5 is upregulated in neurons after stroke, blocking CCR5 induces motor recovery after stroke, and CCR5 antagonism may enhance learning, memory, and plasticity. CCR5 is rapidly becoming an important target for neural repair in stroke and traumatic brain injury. Our recent data that leronlimab crosses the blood-brain barrier with 70-75% receptor occupancy of the CCR5 receptors in the brain (Macaque model) is encouraging for the potential to enhance recovery in stroke and traumatic brain injury and explore a variety of central nervous system pathology."
A second stroke patient was receiving treatment with leronlimab as part of her therapy for breast cancer. The treating physician noted her partial paralysis was mitigated relatively quickly, which may have been causally related to the posited role of CCR5 in stroke.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, "Leronlimab's ability to cross the blood-brain barrier potentially presents numerous opportunities for the treatment of patients suffering from diseases related to the central nervous system. Therefore, we are accelerating the filing of a Phase 2 protocol to evaluate leronlimab's potential as a therapeutic for stroke recovery. We continue to focus our energies on our most important task of enrolling more patients in our severe-to-critical COVID-19 Phase 3 trial as quickly as possible. In addition to moving forward rapidly to complete our Biologics License Application for HIV, in multiple countries, our extensive plan includes filing a protocol and IND for Phase 2 clinical trials for both stroke and Long Haulers COVID-19 indications. We continue to strongly believe leronlimab has the potential to provide therapeutic benefit to patients suffering from a variety of diseases, and this incredible prospect drives our management team every day. CytoDyn is committed to fulfilling this obligation to patients of the world."
About Leronlimab's Ability to Cross Blood-Brain Barrier
The blood-brain barrier (BBB) mediates the communication between the periphery and the central nervous system (CNS). The BBB separates the circulation from the brain. It is a highly selective permeable border of endothelial cells and acts as a metabolic barrier, transport interface, and secretory body. The BBB prevents solutes in the circulating blood from non-selectively crossing into the central nervous system's extracellular fluid where neurons reside. The blood vessels that vascularize the central nervous system (CNS) possess unique functions. The BBB allows precise control of CNS homeostasis. It serves to allow for proper neuronal function and also protects the neural tissue from toxins and pathogens. Alterations of these barrier properties are an important component of central nervous system diseases.An important recent discovery of leronlimab is the ability to cross the blood-brain barrier to treat diseases where CCR5 antagonism may benefit the central nervous system. In a study of HIV in macaques, it was determined that the administration of leronlimab resulted in approximately 70-75% CCR5 receptor occupancy in the frontal lobes, parietal lobes, and cerebellum. Independent research on CCR5 antagonism in central nervous system pathology has shown promise in various disease processes, including multiple sclerosis, Parkinson's disease, CNS tumors, traumatic brain injury, and stroke recovery.
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.CytoDyn is currently conducting its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in numerous hospitals and clinics across the U.S., which are identified on the Company's website under the "Clinical Trial Enrollment" section of the homepage.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company's questions concerning its recent Biologics License Application ("BLA") for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
[email protected] -
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Dr. Rahman's 18 years of pharmaceutical industry experience is highlighted by 16 successful BLA/NDAs and sBLAs
VANCOUVER, Washington, Oct. 21, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the appointment of Mahboob U. Rahman, M.D., Ph.D., FACR, to the executive position of Chief Scientific Officer.
Dr. Rahman was most recently Global Head of Immunology Development and Pharmacovigilance at Mesoblast Inc. (ASX: MSB; Nasdaq: MESO), a global leader in allogenic cellular medicines for inflammatory diseases.
Dr. Rahman received his medical degree from Dhaka Medical College, Bangladesh and a Ph.D. in molecular biology from the Medical College of Pennsylvania. He completed his internal medicine residency at the Medical College of Pennsylvania, Philadelphia and rheumatology fellowship at Massachusetts General Hospital/Harvard Medical School, Boston. He then joined the Harvard Medical School faculty, and obtained an NIH Research Grant. His research interests included molecular mechanisms of joint destruction in inflammatory arthritides, as well as clinical research in various rheumatologic conditions. In early 2002, Dr. Rahman joined Centocor/Johnson & Johnson and was involved in the development of Infliximab, golimumab, ustekinumab and several small molecules as the Rheumatology Clinical Team Leader. In 2010, Dr. Rahman moved to Pfizer as a Vice President and the Therapeutic Area Head for Inflammatory Diseases and was involved in the development of tofacitiniband etanercept. In 2013, he joined Novartis as a Vice President and the Therapeutic Area Head for Immunology and Musculoskeletal Disease, where he was involved in the development of several compounds of which two achieved FDA and EMA approval for marketing, Canakinumab and secukinumab in several indications. In 2018, he joined Glenmark as an Executive VP of Clinical Development and within a month, he became the President and Chief Medical Officer, a position he held until joining Mesoblast in October 2019.
While working in the pharmaceutical industry, Dr. Rahman maintained his educational and clinical activities. He was an adjunct Professor at University of Pennsylvania School of Medicine from 2002 to 2016 and a Clinical Professor at the Rutgers RWJ School of Medicine, Rheumatology Division, from 2016 to 2018. He has published more than 100 scientific papers in peer-reviewed journals.
Scott A. Kelly, M.D., Chairman of the Board, Chief Medical Officer and Head of Business Development for CytoDyn, stated, "We are very pleased Dr. Rahman has joined our executive team. We expect his deep knowledge of immunology and successful regulatory experience to prove invaluable for patients and our Company."
Nader Pourhassan, Ph.D., CytoDyn's President and Chief Executive Officer, commented, "We believe Dr. Rahman's proven track record in our industry, coupled with his medical and research expertise will undoubtedly help accelerate many of our clinical and regulatory priorities. With the addition of Dr. Rahman, along with Dr. Scott Kelly, our CMO, and Dr. Nitya Ray, our CTO, we believe we are well-positioned to move CytoDyn into its next phase of development."
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company's questions concerning its recent Biologics License Application ("BLA") for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
[email protected] -
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DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint
DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days
VANCOUVER, Washington, Oct. 20, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today recommendations from the Data Safety Monitoring Committee (DSMC) following its review of the interim analysis of the Company's Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients.
The DSMC had three recommendations to consider following its review of the interim analysis:
- Stop the trial due to safety concerns;
- Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or
- Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.
The DSMC recommends the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms (leronlimab vs. placebo). Trial enrollment is currently at 230 patients. The Company is working diligently to accelerate patient enrollment in the U.S. and U.K. to achieve the enrollment goal of 293 patients as quickly as possible (potentially in 4-6 weeks), with the goal of full enrollment (390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days.
CytoDyn's Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
CytoDyn's President and Chief Executive Officer, Nader Pourhassan, Ph.D., stated, "We are grateful to the DSMC members for their diligence, guidance and support. We are very pleased by the DSMC's recommendation and this encouraging interim analysis adding to the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients. Concurrently, we are seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.
During today's webcast, we will discuss in depth all of our priorities dedicated to advancing leronlimab as a therapeutic for COVID-19 and all of the opportunities that could be available to us in the coming months." Dr. Pourhassan added, "We look forward to providing additional information during today's webcast."
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company's questions concerning its recent Biologics License Application ("BLA") for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.CYTODYN CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
[email protected] -
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VANCOUVER, Washington, Oct. 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Jacob Lalezari, M.D., Senior Science Advisor, will host an investment community webcast on Tuesday, October 20, 2020, at a new time 2:00 pm PT / 5:00 pm ET, which is one hour later than the previously announced time.
Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Company's Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.
Management will also present slides during the webcast followed by approximately 30-45 minutes to address questions submitted online by analysts and investors.
Date: Tuesday, October 20, 2020
Time: 2:00 pm PT / 5:00 pm ET (NEW REVISED TIME)
Dial-In: None.
Questions: Can be submitted online through the link noted below.This is a "listen only" webcast, which can be accessed via CytoDyn's corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software. The webcast can also be accessed via the following link:
https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/41443/indexl.html
The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until November 20, 2020.
CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
[email protected]