Omega IND Drug Promising For HIV/AIDS Wasting

A three-year Phase II clinical trial on an Investigational New Drug, PCM-4, developed by US-based Omega Pharmaceuticals, has been completed, and the "results were very positive," the company said, indicating that PCM-4 enhances the quality and may lengthen the life of AIDS patients suffering from wasting.

"Several important markers of immune function are stabilized or improved in more than 50% of the patients, according to chief clinical investigator Frank Sutton of the Baptist Health Systems and University of Alabama-Birmingham, and "it is very important to note that trial patients who were taking PCM-4 were not receiving other antiretroviral drugs during year one of the study, while typical non-trial AIDS patients received a variety of other therapies." Tumor necrosis factor appears to be one of the causes of wasting in AIDS patients, and by using PCM-4 to reduce levels of TNF in the body, Omega hopes to control the wasting as well.

An expedited eight-12 week, late-stage Phase II trial has been agreed with the US Food and Drug Administration. And Omega will begin Phase III trials in Zimbabwe in November on 300 HIV/AIDS patients suffering from wasting, said Dr Sutton. The trial has been sanctioned by Zimbabwe's government and its Drug Control Council. Favorable results would allow PCM-4 to be approved for placement on the Essential Drug List for Zimbabwe, which would also expedite approval in 10 additional countries.