US-based biotechnology firm CytoDyn has submitted a revised protocol to the US Food and Drug Administration (FDA) relating to an upcoming Phase IIb clinical trial of its lead product PRO 140 being developed for the treatment of human immunodeficiency virus (HIV) infection.
The Phase IIb study will be carried out by Drexel University College of Medicine and has received a grant from the National Institutes of Health for the same and patient enrolment will likely commence before the end of 2013.
The protocol 2102 is entitled ‘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’.
Prior to the acquisition of PRO 140 by Cytodyn from Progenics Pharmaceuticals in October 2012, initial screening at study sites had started under Protocol 2102, but Progenics stopped the study due to some strategic business reasons.
CytoDyn president and CEO Nader Pourhassan said the company has completed the ‘fill and finish’ process for its PRO 140 bulk drug product and placebo.
“The vials are now available for use in our clinical trials,” Pourhassan said.
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According to the company, PRO-140 is a humanised anti-CCR5 antibody that blocks the HIV co-receptor CCR5 without affecting the normal function of the molecule.
PRO 140 also obtained fast track designation from the FDA for the treatment of HIV infection in February 2006.
Data secured from Phase I and Phase IIa human clinical trials have demonstrated that PRO 140 can reduce viral burden in HIV infected people.
CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV.
The company is focused on the development of subcutaneously delivered humanised cell-specific monoclonal antibodies (mAbs) as entry inhibitors for the treatment and prevention of HIV.
Image: Scanning electron micrograph of HIV-1 (in green) budding from cultured lymphocyte. Photo: courtesy of Optigan13.