CytoDyn Inc. (CytoDyn), a late-stage biotechnology company, announced today that it is currently accepting only 155 more candidates across the country for its Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19.
Three of the sites in Texas where CytoDyn is conducting its trial are University of Texas Health in Houston, Baylor College of Medicine in Houston and Baylor Scott & White Health in Dallas.
CytoDyn has already registered 235 patients in its trial, and the Data Safety Monitoring Committee (DSMC) has just this week recommended that CytoDyn continue its study without modification to achieve its primary endpoint, based on the results seen so far.
“The fact that the DSMC has recommended that we not change anything speaks volumes,” said Nader Pourhassan, CEO of CytoDyn. “Our guess is, it means that our study is not only proving to be safe, but that it is also effective. If it wasn’t, the DSMC would have stopped our trial due to safety or had us change something to increase our effectiveness. But instead, they have simply recommended we continue our study and recruit the remaining 155 patients we need to complete our study to achieve our primary endpoint.”
The DSMC also added that they want to look at the unblinded data again before all 155 patients are enrolled. They would like to have this second look after only another 58 patients are enrolled.
“This, to us, is a very strong signal of positive data,” Pourhassan said.
Pourhassan also said that as early as April of this year, CytoDyn was already receiving very positive news about the effectiveness of its new drug, leronlimab, in severely ill COVID-19 patients under an emergency IND (eIND) authorization from the FDA.
“A young woman in California, Samantha Mottet, is an example of leronlimab’s effectiveness,” Pourhassan said. “She had contracted COVID-19 and was in the hospital on a ventilator. Very soon after receiving a single injection of leronlimab, the amount of oxygen she needed started to drop, and within a short period of time she was able to be removed from her ventilator and later, to be sent home. She says our new drug saved her life.”
CytoDyn received its positive news from the DSMC early last week and is looking to enroll rapidly the 155 patients needed to complete its study as well as the 58 more to have the next DSMC evaluation of the unblinded data
“We are confident that leronlimab will be very helpful to many severely ill COVID-19 patients once our enrollment is completed, or perhaps if 58 more patients could get us an Emergency Use Authorization (EUA) from the FDA,” Pourhassan said.
CytoDyn is currently enrolling severely ill COVID-19 patients in its trial at over 15 hospitals across the U.S. including University of Texas Health in Houston, Baylor College of Medicine in Houston and Baylor Scott & White Health in Dallas.
Those who may be interested in enrolling in the trial are encouraged to contact CytoDyn at their website.
For more information on CytoDyn, please visit www.cytodyn.com