Tuesday PR UK Collaboration (and Fox News Update)
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Posted On: 04/07/2020 6:14:56 AM
CytoDyn Collaborating with U.K.'s Department of Health to Provide Emergency Access to Leronlimab for Severe and Critically Ill COVID-19 Patients
6:00 am ET April 7, 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 that it is collaborating with the U.K.'s Department of Health to provide emergency access to leronlimab, the Company's investigational medicine for COVID-19. The submission to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care, is expected to be made soon to include clinical trial sites in the U.K. Representatives from the U.K. are coordinating with CytoDyn's full-service international clinical research organization, Amarex Clinical Research, to prepare the requisite clinical agreements and to prepare for timely delivery of leronlimab.
The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway. The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.
CytoDyn has initiated enrollment in a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and is enrolling in a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, "We are humbled by the outpouring of inquiries and requests for access to leronlimab and are working around the clock with our many partners to facilitate access to a potential therapeutic benefit for COVID-19 patients." Pourhassan concluded that, "We are working with our CRO partner, Amarex Clinical Research, to establish similar expanded access (emergency use) programs for leronlimab for the treatment of COVID-19 with other governmental regulatory authorities. The Amarex team is leading the clinical trial management and conduct of both Phase 2 and Phase 2b/3 projects and has done an exceptional job leading our clinical development initiative for leronlimab for the treatment of COVID-19."
Separately, Dr. Pourhassan will appear on Fox Business Network on April 7 at 11:00 am PT to provide a full update on the CytoDyn's two clinical trials for COVID-19, a Phase 2 trial for those patients with mild-to-moderate indications and a Phase 2b/3 trial for severe and critically ill patients.
6:00 am ET April 7, 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 that it is collaborating with the U.K.'s Department of Health to provide emergency access to leronlimab, the Company's investigational medicine for COVID-19. The submission to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care, is expected to be made soon to include clinical trial sites in the U.K. Representatives from the U.K. are coordinating with CytoDyn's full-service international clinical research organization, Amarex Clinical Research, to prepare the requisite clinical agreements and to prepare for timely delivery of leronlimab. The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway. The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.
CytoDyn has initiated enrollment in a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and is enrolling in a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, "We are humbled by the outpouring of inquiries and requests for access to leronlimab and are working around the clock with our many partners to facilitate access to a potential therapeutic benefit for COVID-19 patients." Pourhassan concluded that, "We are working with our CRO partner, Amarex Clinical Research, to establish similar expanded access (emergency use) programs for leronlimab for the treatment of COVID-19 with other governmental regulatory authorities. The Amarex team is leading the clinical trial management and conduct of both Phase 2 and Phase 2b/3 projects and has done an exceptional job leading our clinical development initiative for leronlimab for the treatment of COVID-19."
Separately, Dr. Pourhassan will appear on Fox Business Network on April 7 at 11:00 am PT to provide a full update on the CytoDyn's two clinical trials for COVID-19, a Phase 2 trial for those patients with mild-to-moderate indications and a Phase 2b/3 trial for severe and critically ill patients.
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