NP may not be making the call on this matter. The CRO and the medical center were involved in the development of the trial. The way I read the partnership CYDY can/may be consulted.
P/R
May 05, 2021 3:35am EDT
Interim analysis for critically ill population will be conducted when enrollment reaches about 120 patients or 40% of the approximate 300 patients
VANCOUVER, Washington, May 05, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today 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, M.D., 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.”
P/R
May 05, 2021 3:35am EDT
Interim analysis for critically ill population will be conducted when enrollment reaches about 120 patients or 40% of the approximate 300 patients
VANCOUVER, Washington, May 05, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today 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, M.D., 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.”
2
