CytoDyn Announces FDA Approval of Patient Screening for Phase 2b Study with Lead Product Candidate PRO 140 for the Treatment ...
Cytodyn, Inc. (QB) (USOTC:CYDY)
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Today : Tuesday 7 January 2014
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PRO 140 belongs to a new, ground-breaking class of therapeutics with the potential to change the treatment paradigm for patients with HIV/AIDS
Study being conducted by leading HIV expert, Jeffrey M. Jacobson, M.D., at Drexel University
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.
About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that are intended to protect healthy cells from viral infection. PRO 140 is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.
PRO 140 has been the subject of four Phase 1/1b and two Phase 2a clinical trials, each of which demonstrated PRO 140’s ability to significantly reduce HIV viral load in human test subjects, and has also been designated a “fast track” product candidate by the United States Food and Drug Administration. The PRO 140 antibody appears to be a powerful antiviral agent while not being a drug, leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.
About CytoDyn
CytoDyn is a biotechnology company focused on developing subcutaneously delivered humanized cell-specific monoclonal antibodies (mAbs) as entry inhibitors for the treatment and prevention of Human Immunodeficiency Virus (HIV). The Company has one of the leading mAbs under development for HIV infection PRO 140 which is a Late Stage II humanized mAb with demonstrated antiviral activity in man. PRO 140 blocks the HIV co-receptor CCR5 and clinical trial results thus far indicate that it does not affect the normal function of the cell. Results from Phase 1/1b and Phase 2a human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV. For more information on the Company please visit www.cytodyn.com.
