CytoDyn receives FDA approval to start Phase 2b study of PRO 140 for treatment of HIV-1

CytoDyn Inc.Jan 8 2014

CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today the Company has received approval from the United States Food and Drug Administration (FDA) to commence patient screening of a Phase 2b study of PRO 140, a monoclonal CCR5 antibody, for the treatment of patients with Human Immunodeficiency Virus Type 1 (HIV-1). The Phase 2b study is being conducted by Drexel University College of Medicine and funded by grants from the National Institutes of Health (NIH).

"The start of patient screening for our Phase 2b study is the first step in the robust clinical development strategy we are initiating for PRO 140 in 2014," stated Dr. Nader Pourhassan, CytoDyn's President and CEO. "With the completion of our recent equity financing and a strong team in place, including the recent appointment of the FDA's former Director of the Division of Anti-infective and Antiviral Drug Products, Dr. David Feigal, we are focused on aggressively advancing PRO 140 through multiple human clinical trials."

David Feigal, M.D., CytoDyn's Chief Medical Officer, commented, "We believe that commencement of this study brings us one step closer to offering a new treatment paradigm for patients with HIV, who haven't seen any game-changing therapeutic options come to the market in years."

PRO 140 Phase 2b Study Design

This study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial of observed systemic, long-acting, anti-HIV treatment with PRO 140 as an adjunct to an optimized oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen. The primary study objective will be to assess the antiviral effects, tolerability and patient acceptance of PRO 140 or placebo administered subcutaneously weekly for 24 weeks in combination with an optimized background oral antiretroviral regimen.

"I am pleased to be collaborating with CytoDyn on advancing PRO 140 and applying this exciting new treatment approach to patients with HIV in a Phase 2b clinical study," said Dr. Jeffrey M. Jacobson, Professor of Infectious Disease and HIV Specialist at Drexel University College of Medicine, who oversaw PRO 140's initial trial development.