CytoDyn and NIH of Mexico Complete Memorandum of Understanding to Conduct Small Covid-19 Phase 3 Trial for Severe and Critically Ill Patients
VANCOUVER, Washington, June 29, 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 the Company and the Coordinating Commission of the National Institutes of Health and High Specialty
Hospitals of Mexico (NIH) have entered into a Memorandum of Understanding (MOU) to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to
collaborate on additional COVID-19 trials. The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country.
The MOU provides CytoDyn will supply leronlimab at its expense to the NIH and both parties are proceeding forward expeditiously to complete the mutually agreed protocol for this clinical trial.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: “We are very pleased with the confidence demonstrated by the NIH of Mexico in our drug, leronlimab, and we are both very motivated to initiate this trial quickly to help mitigate the devastation of the COVID-19 pandemic on the citizens of Mexico. The anecdotal data received by CytoDyn (from over 70 COVID-19 critical patients who were treated under EIND in the U.S.) has impressed the NIH of Mexico and we believe with a small Phase 3 trial of only 25 patients, leronlimab could receive approval in Mexico very quickly. This Phase 3 trial is similar to our Phase 3 trial protocol in the U.S., with the exception of the number of patients.”
About Coronavirus Disease 2019
CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.