CytoDyn Inc. ("CytoDyn") (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, today announced that CytoDyn Chief Medical Officer David Feigal, M.D., has submitted a revised protocol to the U.S. Food and Drug Administration relating to an upcoming Phase IIb clinical trial of PRO 140, CytoDyn's leading product under development as a treatment for Human Immunodeficiency Virus (HIV) infection.
The submission was for protocol 2102 titled, "Randomized, Double-blind, Placebo-controlled Clinical Trial of Observed Systemic, Long-acting, Anti-HIV treatment with a Monoclonal CCR5 antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Recreational Drug Users with Viral Rebound and Poor Adherence to the Previous Antiretroviral Regimen." Drexel University College of Medicine has received a grant from the National Institutes of Health to fund this clinical trial.
Prior to CytoDyn's acquisition of PRO 140 from Progenics Pharmaceuticals, Inc., in October 2012, initial screening at study sites had commenced under Protocol 2102, but Progenics halted the study for strategic business reasons. Current plans call for opening the study for enrollment before the end of 2013.
"This continues to be a very exciting year for the Company," said CytoDyn President and CEO Dr. Nader Pourhassan. "We have completed the 'fill and finish' process for our PRO 140 bulk drug product and placebo. The vials are now available for use in our clinical trials," he added.
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