CytoDyn Reaches Agreement with Albert Einstein Israelite Hospital in Brazil to Conduct Two COVID-19 Trials–Small Trial in Critically Ill and Large Trial in Severely Ill Populations

On May 5, 2021, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a chemokine receptor type 5 (CCR5) antagonist with the potential for multiple therapeutic indications, announced the agreement to partner with Academic Research Organization (ARO)--Albert Einstein Israelite Hospital (AEIH) in São Paulo, Brazil for two COVID-19 trials. The COVID-19 trials in Brazil are intended to provide the Brazilian regulatory authority, ANVISA, with the requisite data to consider advancing the availability of leronlimab to thousands of Brazilians infected with COVID-19. These two Phase 3 trials will be conducted in up to 45 clinical sites. Chris Recknor, MD, CytoDyn’s Chief Operating Officer and Head of Clinical Development, commented, “We are pleased to partner with one of the best hospitals in Latin America, the Albert Einstein Israelite Hospital, and their affiliated academic research organization network. This ARO has conducted multiple large-scale COVID trials for many pharmaceutical companies. CytoDyn is utilizing their extensive experience to develop and conduct our CD16 and CD17 COVID-19 trials. With approximately 1,500 patients in total for both trials, we anticipate having adequate power in each trial to achieve a significant p-value for our endpoints and will be performing an interim analysis after 40% of the critically ill patients are enrolled. In Brazil, the P1 COVID variant is fueling a second wave worse than the initial outbreak. In April, more than 78,000 people lost their lives from COVID and ICU capacity in 15 of Brazil’s 26 states, is at or above 90% full. Vyrologix is variant agnostic. We expect an interim analysis will be conducted in October-November of this year. We look forward to accelerating these trials for the benefit of the Brazilian people.”
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