Gynex Pharmaceuticals Inc. said Monday that it will beginwithin 30 days Phase II trials of Oxandrin to treat AIDSpatients suffering from HIV-associated muscle weakness.
Both the virus and AZT, a drug commonly used to treat AIDSpatients, can cause muscle weakness. Oxandrin (oxandrolone) isa testosterone analog that acts on androgenic receptor sites onmuscle cells, causing growth of muscle cells, said StephenSimes, president of the Vernon Hills, Ill., company. The drugalso has anti-catabolic (anti-wasting) activity at theglucocorticoid receptors on muscle cells. It may also indirectlystimulate appetite, the production of growth hormone andpossibly the immune system.
Gynex (NASDAQ:GYNX) also plans to conduct trials of Oxandrinin patients with HIV wasting syndrome, for which the drug hasorphan designation. The syndrome is characterized by loss of10 percent or more of body weight.
The company plans to file for marketing approval of the drugfor alcoholic hepatitis by the end of this year and for Turnersyndrome in girls and constitutional delay of growth andpuberty in boys in 1993.
Gynex obtained exclusive rights to oxandrolone in 1990 fromG.D. Searle & Co. after low sales caused Searle to stop marketingthe drug in 1989.
Gynex shares rose 6 cents on Monday to $3.31. -- KarenBernstein
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