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CytoDyn Enrolls First Two Patients In Phase 2 COVID-19 Trial With Leronlimab

Biotechnology company CytoDyn Inc. (CYDY.OB) announced Monday that it has enrolled and treated the first two COVID-19 patients with leronlimab under its Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.

The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab, and calls for 75 planned patients in up to 10 centers in the United States.

In addition, the company's investigational new drug leronlimab, which was granted emergency investigational new drug (EIND) status by the FDA, has now been administered to 15 severely ill COVID-19 patients at four hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals.

CytoDyn also anticipates initiating its Phase 2b/3 trial for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio), with the primary endpoint being the mortality rate at 14 days.

The FDA has already granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.

CytoDyn is developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.

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