Cytodyn initiates first clinical site for Phase III Trial of PRO 140 in HIV-positive patients

The company is focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection.

The primary end point of the Phase III trial is to reduce the viral load in HIV patients, who have experienced a viral load breakout, by 0.7log (a 5-fold drop) in one week with one 350mg dose of PRO 140.

The company noted that a Phase IIa trial completed in 2009 with HIV patients, showed a viral load suppression of more than 1log (a more than 10-fold drop) in one week with one 324mg dose of PRO 140 (nearly a 10% lower dosage).

CytoDyn president and CEO Dr Nader Pourhassan said: "We are very pleased with Amarex Clinical Research’s performance in initiating new sites for our current Phase III study.

"We believe that our recent $7.3m equity raise will continue to support an expeditious commencement of our Phase III trial."

The trial’s primary end point will be met if PRO 140 achieves half of what it previously showed with a nearly 10% higher dosage compared to the earlier study.

In the last 24 weeks of the Phase III trial, patients will be allowed to change their failing pill regimen to a new optimized regimen, coupled with a weekly 350mg injection of PRO 140.

PRO 140 belongs to a new class of HIV/AIDS therapeutics that are intended to protect healthy cells from viral infection.

It is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells, while the antibody also blocks the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5.