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BusinessWire,8月3日,CytoDyn Receives Clearance from Brazil’s ANVISA to Commence Phase 3 Trial for Severe COVID-19 Patients

编译者:YUTING发布时间:Aug 7, 2021点击量:410 来源栏目:最新研究

VANCOUVER, Washington--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved the previously submitted clinical trial protocol to commence patient enrollment in its CD17 trial for severe COVID-19 patients. The Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH) in Brazil will conduct the trial.

The COVID-19 trial in Brazil is intended to provide ANVISA with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19. This Phase 3 trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support. The trial aims to prevent the disease from evolving into a more severe case, requiring invasive mechanical ventilation. Additionally, ANVISA is reviewing another protocol submitted for a second clinical trial for 316 critically ill COVID-19 patients.

The Phase 3 trial for severe COVID-19 patients has built in an interim analysis to be conducted after 40% (245) of the patients have been enrolled and the last-enrolled patient has completed 28 days of treatment with leronlimab.

Chris Recknor, M.D., CytoDyn’s Chief Operating Officer and Head of Clinical Development, commented, “As of July 2021 Brazil had the highest number of confirmed cases from COVID-19 in Latin America and ranked third highest in the world. The CD17 trial was designed in collaboration with our partners at Einstein ARO and BIOMM to have an adequately powered interim analysis after 40% of the patients have been enrolled and completed 28 days of treatment with leronlimab. Given that average weekly cases currently are over 35,000, we anticipate that the results of the interim analysis may be available in the next three to four months using the endpoints we refined from CD12.”

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We are very grateful to ANVISA and for the hard work of all involved including ARO, BIOMM, and CytoDyn. It has been a challenging road, but we are pleased to be in the position to potentially have results from two COVID-19 trials in Brazil and potentially one COVID-19 long hauler trial in the US. We truly believe our CD12 data has been crucial for us in designing these new trials in Brazil to give leronlimab the best chance at success.”

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