U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

A leading academic medical center has administered the test medication, leronlimab, in two of their sickest COVID-19 patients. Neither patient has had any serious adverse reactions to leronlimab since it was administered. We are hopeful leronlimab will provide help to severely ill COVID-19 patients.
VANCOUVER, Washington, March 19, 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 two coronavirus patients were treated with the Company’s investigational new drug, leronlimab. The treatment was administered at a leading medical center in the New York City area under an emergency Investigational New Drug (IND) recently granted by the U.S. Food and Drug Administration (FDA). Leronlimab is intended to serve as a therapy for patients who experience respiratory illness as a result of contracting the Coronavirus Disease 2019 (COVID-19). The treatment of these patients was not under the Company’s proposed randomized controlled Phase 2 clinical trial protocol recently submitted to the FDA.

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Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation

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The drug, leronlimab, is delivered by injection twice in the abdomen, the Daily Mail reported.

Of seven critically ill patients who received the drug in New York, two were removed from ventilators and two showed significant improvement.

Doctors right now don’t know quite how leronlimab works, but studies suggest it calms the overly aggressive immune response — known as a cytokine storm — that frequently leads to lung inflammation, pneumonia and potentially death.





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