FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients

Nachrichtenquelle: globenewswire
31.12.2020, 05:39  |  529   |   |   

The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization

VANCOUVER, Washington, Dec. 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the U.S. Food and Drug Administration (“FDA”) has accepted the protocol submitted on December 28 for adding an open-label extension to its Phase 3 trial (“CD12”). Hospitals previously participating in the CD12 trial now have the option of enrolling additional eligible patients, with all patients receiving leronlimab. Treatment for eligible patients will continue until further notified by the FDA and/or CytoDyn.

The FDA also provided specific guidance for the benefit of physicians seeking access to leronlimab under an eIND for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study. The agency specified certain subgroups of patients will be excluded from the eIND authorization process: mild/moderate COVID-19, mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg and on vasopressors >48 hours.

Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Head of Clinical Development for CytoDyn, stated, “We appreciate the specificity of the guidance from the FDA, as this will facilitate a prompt and efficient review and approval process for qualified patients. As the pace of this pandemic is not slowing down in the foreseeable future, providing a safe and effective treatment is the highest priority for all.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are most thankful to the FDA for their acceptance of the open-label extension to allow access to leronlimab for eligible patients and the definitive criteria provided for the benefit of physicians considering an eIND for their COVID-19 patients.”

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. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.

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FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization VANCOUVER, Washington, Dec. 30, 2020 (GLOBE NEWSWIRE) - CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the …

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