Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - October 26, 1995
INVESTIGATIONAL NEW DRUG SHOWS PROMISING RESULTS IN CONTROLLING WASTING FOR HIV/AIDS PATIENTS
MINNEAPOLIS, Oct. 25 /PRNewswire/ -- Omega Pharmaceutical, Inc. today announced that it has recently completed a three-year phase II clinical trail on an Investigational new Drug called PCM-4. "Results were very positive, and indicate that PCM-4 enhances the quality and may lengthen the life of AIDS patients suffering from wasting," says Chief Clinical investigator Frank D. Sutton, Jr., M.D. of the Baptist Health Systems and University of Alabama-Birmingham. "Several important markers of immune function are stabilized or improved in more than 50 percent of the patients. 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."
PCM-4 is a product consisting of three compounds: polypeptides, glycopeptides and glycosides. "PCM-4 is unique in that it consists only of naturally occurring substances, is non-toxic, and has virtually no side-effects," Dr. Sutton says. "There are currently four FDA approved antiretroviral drugs available to HIV/AIDS patients. The most recognized is AZT, but drugs like these are toxic, and while they seek out and kill the virus, they may simultaneously harm healthy parts of the body such as the liver and bone marrow.
"Tumor Necrosis Factor (TNF) 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," says Dr. Sutton. The FDA and Omega have agreed that Omega will conduct an expedited 8-12 week, late-stage Phase II clinical trial on HIV/AIDS patients experiencing rapid weight loss in the very near future. The protocol is being prepared and site selection is underway.
In addition to the current U.S. development program, Omega will begin a Phase III clinical trial in Zimbabwe in November. "We will be working with 300 HIV/AIDS patients suffering from wasting," says Dr. Sutton. The trial has been sanctioned by the government of Zimbabwe and their 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 African countries.
CONTACT: Omega Pharmaceutical at 205-969-3003 for information on enrolling in the upcoming U.S. Trial. Media Contact: Nicki Gibbs, 612-798-7209, or 800-999-4859/ 11:04 EDT
Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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