FDA Approves 54 Emergency INDs for Leronlimab Treatment of Corona Virus; CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible for Participation in Two Ongoing Clinical Trials in U.S.

On May 4, 2020, CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage, Vancouver, Washington-based biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the Company is expecting enrollment completion for its 75 patient, Phase 2 double-blinded, placebo-controlled, randomized study by the end of this month. CytoDyn has submitted a request to the FDA to grant expanded access, also known as “compassionate use,” to make leronlimab available for patients not eligible for participation in two ongoing clinical trials for coronavirus infections. Many severe and critically-ill patients, who have received off-label immunomodulatory treatments for COVID-19, are excluded from participation in the Company’s Phase 2b/3 clinical trial and could potentially benefit from access to leronlimab under a compassionate use program. There are 49 COVID-19 patients who have enrolled for treatment with leronlimab through emergency INDs (eINDs). Four out of 11 critically ill patients with a multitude of pre-existing conditions survived after treatment, and of the next 38 patients, many were extubated, improved, or were discharged. Nader Pourhassan, PhD, Director, President, and Chief Executive Officer of CytoDyn, said, “We are very excited about the continuing positive responses from eIND patients following their treatment with leronlimab. We are equally excited about the prospects for patients should the FDA grant access to leronlimab under the compassionate use program. During this past Saturday, we had to overcome many obstacles for two patients who desperately wanted leronlimab. One patient was in the same hospita (Montefiore Medical Center in New York City) that enrolled the first 11 patients and the second was a well-known patient in Los Angeles.
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