CytoDyn Inc. (OTCMKTS: CYDY) has announced the treatment of the first patient in the pivotal third phase COIVID-19 study in Brazil for patients showing severe symptoms. The company plans to conduct a preliminary analysis after 28 days after enrolment of 245 patients, around 40% of the number of subjects to be enrolled in the study.
CytoDyn to enroll 612 patients
Academic Research Organization (ARO) Albert Einstein Israelite Hospital is leading this critical Phase 3 trial for severe COVID-19 patients, as previously disclosed. The goal of this trial is to offer the necessary data to ANVISA, Brazil’s regulatory agency, so that it may consider expanding the availability of leronlimab to infected Brazilians with COVID-19. The experiment will be undertaken at up to 35 clinical sites with 612 hospitalized patients who require oxygen support.
CytoDyn CEO and President Nader Pourhassan said, “We are very encouraged enrollment for this first trial is underway and look forward to reaching our interim analysis target as soon as possible. We believe our second trial in Brazil will also initiate very soon as ANVISA has cleared the trial with a condition of more information about CMC, which will be provided to ANVISA no later than September 13.”
CytoDyn expects to conduct more trials in Brazil
Pourhassan continued, “Today marks the first day of the much anticipated clinical trial in Brazil that we have been waiting for and we are so grateful to our team who conducted the CD12 trial in U.S. that produced a wealth of information for us to be able to appropriately design and power these two studies. We also give especial thanks to the ARO team for a job well done and look forward to many more trials to be conducted by them in Brazil with leronlimab. We also thank the BIOMM team for exceptional work to finalize this protocol with ANVISA and providing very valuable guidelines to our team.”