CYDY), (“CytoDyn” or the “Company”), a terminal biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients were treated with leronlimab as part of the company’s Phase 2 randomized clinical trial, which is intended for patients with mild to moderate indications. The company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites. »Data-reactid =” 13 “> VANCOUVER, Washington, April 6, 2020 (GLOBE NEWSWIRE) – CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a terminal biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID patients -19 were treated with leronlimab in the company’s Phase 2 randomized clinical trial for patients with mild to moderate indications. The company expects to recruit more patients this week at several clinical sites.
In addition, the Company’s new investigational drug, leronlimab, has been administered to 15 seriously ill COVID-19 patients in four hospitals, 10 patients treated at a premier New York area medical center and five patients in three other hospitals, all under a new emergency research drug (EIND), which has been granted by the United States Food and Drug Administration (FDA) for each patient.
CytoDyn also plans to launch its other COVID-19 trial this week. This trial is a 2b / 3 phase for seriously ill COVID-19 patients and concerns 342 patients, double blind with a 2: 1 ratio (drug / placebo ratio). Patients included in this trial should receive leronlimab for two weeks, the main criterion being the 14-day mortality rate. The Company will perform an interim analysis of the data from 50 patients after two weeks of treatment with leronlimab.
Bruce Patterson, M.D., CEO and founder of CytoDyn’s diagnostic partner and consultant, IntellDx, said, “We are encouraged by the positive results demonstrated with leronlimab in New York patients. Our team is working hard to distribute leronlimab to several clinical sites to initiate treatment in patients with severe COVID-19 disease. As each patient experiences different comorbidities, we see similar clinical responses, which we believe reflect the mechanism of action of leronlimab. “
Nader Pourhassan, Ph.D., president and CEO of CytoDyn, said: “Our partnership with the New York medical team and now other hospitals has been exemplary. We collaborate in all aspects to deliver léronlimab to patients in order to provide a proof of concept as soon as possible. We hope that the exceptional coordination between doctors, hospital administrators, the FDA and our team will help to mitigate the deleterious effects of this pandemic if we prove leronlimab as a solution. The chief medical officer in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the COVID-19 pandemic. We very much hope to send the results of the first ten days and seven days of the first ten EIND patients to the FDA by the end of the week. “
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In the context of HIV / AIDS, leronlimab is an inhibitor of viral entry; it masks CCR5, thereby protecting healthy T cells from viral infection by preventing the predominant HIV subtype (R5) from entering these cells. Leronlimab has been tested in nine clinical trials, each of which has shown that leronlimab can significantly reduce or control the viral load of HIV in humans. The leronlimab antibody appears to be a potent antiviral agent, potentially leading to fewer side effects and less frequent dosing requirements compared to the current daily drug treatments.
In the context of cancer, research has shown that CCR5 can play a role in tumor invasion, metastasis and control of the tumor microenvironment. Increased expression of CCR5 is an indicator of the disease state 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 metastases from human breast cancer by more than 98% in a mouse xenograft model. CytoDyn is therefore conducting a phase 1b / 2 human clinical trial on triple negative metastatic breast cancer and obtained the Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating the trafficking of immune cells to sites of inflammation. It can 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 with a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting bone marrow stem cell transplantation transplanted. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on transplanted cells is essential for the development of acute GvHD, preventing the CCR5 receptor from recognizing specific immune signaling molecules is one viable approach to alleviate acute GvHD. . The FDA has granted leronlimab an “orphan drug” designation for the prevention of GvHD.
www.cytodyn.com. “Data-reactid =” 27 “>About CytoDyn
CytoDyn is an advanced biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a new humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play an essential role in the ability of HIV to enter and infect healthy T cells. The CCR5 receptor also appears to be involved in tumor metastases and immune-mediated diseases, such as GvHD and NASH. CytoDyn has successfully completed a pivotal phase 3 trial with leronlimab in combination with standard antiretroviral therapy in patients experienced with HIV treatment. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the application for a biological license (BLA) in April 2020 for this indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a weekly monotherapy for patients with HIV infection. CytoDyn plans to launch a study based on the registration of the indication for leronlimab as monotherapy. If successful, it could support label extension. To date, clinical results from several trials have shown that leronlimab can significantly reduce viral load in people with HIV without a serious drug-related adverse event (SAE). In addition, a phase 2b clinical trial has shown that leronlimab monotherapy can prevent viral leakage in patients with HIV infection; some patients on leronlimab monotherapy have been virally suppressed for more than five 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 triple negative metastatic breast cancer. More information on www.cytodyn.com.
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