CytoDyn Applies To FDA For Phase 2b Clinical Study Of PRO 140

CytoDyn Inc. announced via press release that it submitted a Phase 2b clinical trial protocol to the Food and Drug Administration (FDA). The study is for PRO 140, a humanized monoclonal antibody for the treatment of infection in immune deficiency viruses. The objective of this trial is to test PRO 140 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. Nader Pourhassan, CytoDyn’s President and CEO said, “We believe our 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.”

Human Immunodeficiency Virus

Human immunodeficiency virus (HIV) is the virus that causes acquired immune deficiency syndrome (AIDS). The virus attacks the immune system, causing deficits in the body’s ability to fight infection. HIV patients become unable to fight infections that would not normally affect a non-infected person. About 40,000 new HIV cases are reported each year.  No cure has been found yet. Treatments help manage symptoms and improve the quality of life. Antiretroviral therapy helps stop the HIV virus from replicating. A combination of drugs known as highly active antiretroviral therapy (HAART) stops replication, improves T-cell count, and repairs damage to the immune system. 

PRO 140

PRO 140 is for HIV patients who are doing well on HAART but choose to take a break from the combination of drugs. This drug holiday or structured treatment interruption allows the immune system to recover some of its power and fight the HIV infection on its own or with strategic treatment. This new agent is a human monoclonal antibody belonging to a class of drugs known as entry inhibitors. The agent blocks a molecular portal (CCR5) that the HIV virus uses to infect cells, protecting healthy cells from infection.

The FDA gave PRO 140 a Fast Track Designation, reinforcing the FDA’s commitment to finding new agents for HIV. In Phase I and II clinical trials, PRO 140 showed a significant ability to reduce HIV viral load. It has few side effects and patients need fewer doses compared to other therapies. In the proposed Phase 2b study, CytoDyn intends to test the efficacy of PRO 140 monotherapy.