Cytodyn gets FDA approval to begin patient screening in Phase IIB study of HIV drug

9th January 2014 (Last Updated January 9th, 2014 06:30)

US-based biotechnology firm CytoDyn has received approval from the US Food and Drug Administration (FDA) to start patient screening for a Phase IIb study of PRO 140, a monoclonal CCR5 antibody, to treat patients with human immunodeficiency virus type 1 (HIV-1).

HIV virus

US-based biotechnology firm CytoDyn has received approval from the US Food and Drug Administration (FDA) to start patient screening for a Phase IIb study of PRO 140, a monoclonal CCR5 antibody, to treat patients with human immunodeficiency virus type 1 (HIV-1).

Drexel University College of Medicine is conducting the multicentre, randomised, double-blind, placebo-controlled Phase IIb clinical trial, which is being funded by grants from the National Institutes of Health (NIH).

CytoDyn president and CEO Nader Pourhassan said: "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."

"We believe that commencement of this study brings us one step closer to offering a new treatment paradigm for patients with HIV."

The Phase IIb study design involves observed systemic, long-acting, anti-HIV treatment with PRO 140 as an adjunct to an optimised oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen.

Primary objective of the trial will be to evaluate the antiviral effects, tolerability and patient acceptance of PRO 140 or placebo administered subcutaneously weekly for 24 weeks in combination with an optimised background oral antiretroviral regimen, the company added.

CytoDyn chief medical officer David Feigal said: "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 is a humanised monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.

It has been the subject of four Phase I/Ib and two Phase IIa clinical trials, each of which showed PRO 140's ability to reduce HIV viral load in human test subjects, and has also received FDA 'fast-track designation'.


Image: PRO 140 belongs to a new class of HIV/AIDS therapeutics. Photo: courtesy of freedigitalphotos.net.