FDA Clears CytoDyn’s Phase 2 Randomized Trial to
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Posted On: 03/31/2020 6:01:25 AM
FDA Clears CytoDyn’s Phase 2 Randomized Trial to Treat Mild-to-Moderately Ill Coronavirus Patients with Leronlimab; Enrollment to Begin Immediately
March 31, 2020 6:00am EDT
VANCOUVER, Washington, March 31, 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 the U.S. Food and Drug Administration (FDA) just provided clearance for initiation of a Phase 2 trial with CytoDyn’s leronlimab to treat COVID-19 patients with mild to moderate indications. The Company’s investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The treatment with leronlimab is intended to serve as a therapy for patients who experience mild-to-moderate respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).
The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “We are very pleased with the FDA’s responsiveness to facilitate the commencement of this important Phase 2 trial. In light of the test results of the various immunologic markers from the critically ill patients treated under the emergency IND, we remain hopeful that leronlimab may be therapeutically beneficial to those COVID-19 patients with mild to moderate indications.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “The FDA has been very collaborative with our team to accelerate the opportunity to introduce a potentially beneficial treatment to so many patients affected by this horrific pandemic. We hope to complete enrollment of this trial very quickly.”
March 31, 2020 6:00am EDT
VANCOUVER, Washington, March 31, 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 the U.S. Food and Drug Administration (FDA) just provided clearance for initiation of a Phase 2 trial with CytoDyn’s leronlimab to treat COVID-19 patients with mild to moderate indications. The Company’s investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The treatment with leronlimab is intended to serve as a therapy for patients who experience mild-to-moderate respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “We are very pleased with the FDA’s responsiveness to facilitate the commencement of this important Phase 2 trial. In light of the test results of the various immunologic markers from the critically ill patients treated under the emergency IND, we remain hopeful that leronlimab may be therapeutically beneficial to those COVID-19 patients with mild to moderate indications.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “The FDA has been very collaborative with our team to accelerate the opportunity to introduce a potentially beneficial treatment to so many patients affected by this horrific pandemic. We hope to complete enrollment of this trial very quickly.”
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