CytoDyn Files New Protocol with FDA for 4 Doses of Leronlimab for Critically Ill COVID-19 Patients

 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 that after several weeks of discussions with the U.S. Food and Drug Administration (“FDA”) and analysis of CD12 trial data, and in particular the 82% survival results over placebo after two weeks of leronlimab treatment, with statistically significant p-value of 0.0233, the Company has filed a new protocol to extend treatment to four weeks. The Company will initiate patient enrollment in multiple countries, including Brazil, where there are over 20,000 COVID-19 patients in ICU. CytoDyn believes four weeks of leronlimab treatment to be sufficient to calm the cytokine storm and to have a positive effect on survival rate at 4 weeks and potentially 8 weeks.

https://www.globenewswire.com/news-release/2021/04/01/2203092/19782/en/CytoDyn-Files-New-Protocol-with-U-S-FDA-for-4-Doses-of-Leronlimab-for-Critically-Ill-COVID-19-Patients-with-the-Objective-to-Duplicate-or-Surpass-82-Survival-Benefit-with-P-Value-o.html