A new innovation in medical practice is nearing the finish line in finding a treatment for AIDS and HIV. A small-cap biotechnoogy firm, CytoDyn, is advancing in finding a treatment and prevention of the Human Immunodeficiency Virus (HIV).

The Washington.based company has recently received a a go-signal from the U.S. Food and Drug Administration (FDA) to proceed with its research on HIV cure with 40 patients.

PRO-140 Advances in Clinical Trials

Cytodyn's PRO 140 is seen as a better alternative to expensive treatments for AIDS.

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 FDA.

The PRO 140 antibody appears to be a powerful antiviral agent while not being a drug, potentially leading to fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.

Clinical Trials

In February this year, CytoDyn submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the for treatment substitution in patients with HIV. PRO 140 is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells, and belongs to a class of HIV therapies known as entry inhibitors that block HIV from entering into and infecting certain cells.

In this Phase 2b study, Cytodyn's primary objective is to assess the efficacy of PRO 140 monotherapy for the maintenance of viral suppression in HIV patients who are stable on combination antiretroviral therapy, known as HAART (highly active antiretroviral therapy), but need or wish to discontinue HAART therapy temporarily.

In March, CytoDyn received approval from the FDA to commence patient screening of a Phase 2b study of PRO 140. 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 said in a statement.

"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."

Pourhassan added that treatment substitution study has the potential to provide a drug holiday to patients from their daily pill regimen. PRO 140 could be the key to maintaining viral load suppression during a drug holiday. If the study has a positive outcome, we believe this may address a significant unmet medical need and have high patient acceptance."

David Feigal, M.D., CytoDyn's Chief Medical Officer, commented, "We are entering an important phase with our plans for advancing the development of PRO 140. I am excited to be leading the clinical development of PRO 140 and look forward to exploring its utility in treatment substitution. Importantly, I believe we are another step closer to bringing the first antibody for the treatment of HIV to the market."

"The FDA recently approved the study drug manufacturing and quality (CMC) of PRO 140 in connection with use in other clinical trials. While we await receipt of FDA comments on our treatment substitution protocol, we are working on selecting study sites and preparing to launch patient screening and enrollment for the study," Dr. Feigal added.

Dr. Pourhassan and his team continue to unlocking the potential of PRO 140 as early indications show its potential to treat HIV.