CytoDyn Achieves Primary Endpoint

CytoDyn has successfully achieved the primary endpoint in its CD02 Phase 2b/3 pivotal clinical trial with PRO 140 in combination with existing antiretroviral therapy (ART) in patients failing their current HIV therapy. 

The trial data show a statistically significant reduction in HIV-1 RNA viral load of greater than 0.5log with PRO 140 versus placebo. CytoDyn is developing PRO 140, a humanized CCR5 monoclonal antibody, to combat human immunodeficiency virus (HIV) infection and certain immunologic disorders.

“These data clearly demonstrate the anti-HIV-1 activity of PRO 140 in antiretroviral treatment-experienced individuals who were documented to have ongoing virus replication in the face of therapy with currently approved drugs,” said Scott M. Hammer, MD, Harold C. Neu Professor and chief of the Division of Infectious Diseases, Columbia University Medical Center/New York-Presbyterian Hospital. “Antiviral drug resistance is an ongoing threat to HIV infected persons. Despite the dramatic progress in treatment success over the course of the epidemic, we cannot be complacent. PRO 140 is a clear example of the advances in HIV therapeutics that can result from the dedication of developers, patients and providers to this principle.”