CytoDyn receives FDA approval for Phase 2b study of new HIV treatment

CytoDyn, Inc., said on Tuesday that it received approval from the Food and Drug Administration to move forward with a Phase 2b study on PRO 140, a monoclonal CCR5 antibody for patients with HIV Type 1.

The Drexel University College of Medicine is conducting the study, which is funded with grants from the National Institutes of Health.

"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," Nader Pourhassan, the president and CEO of CytoDyn, 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."

Feigal, now the chief medical officer at CytoDyn, said the study will assist in offering a new treatment program for patients.

PRO 140 is a viral-entry inhibitor that protects healthy cells from viral infection. The medication is an antibody that blocks the CCR5 portal, which is used by HIV to enter healthy cells.

Previous tests and studies showed PRO 140 to be an antiviral agent with fewer potential side effects and less frequent dosing requirements than current daily drug therapies.

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National Institutes of Health

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