Gynex Pharmaceuticals Inc. said Wednesday that it started apreviously announced multicenter Phase II study of itsOxandrin drug for treating HIV-associated muscle weakness inAIDS patients.
The study is to determine the safety and effectiveness ofOxandrin in restoring body mass and muscle strength to AIDSpatients. The 16-week study is designed for 48 patients and isbeing conducted at the University of Miami, Mt. Sinai MedicalCenter in New York and the University of North Carolina atChapel Hill. Study results are expected by early 1993.
Gynex (NASDAQ:GYNX) of Vernon Hills, Ill., aims to startanother trial of Oxandrin as an adjunctive therapy for HIV-related wasting syndrome, on which it has a federal orphandrug designation, said Stephen M. Simes, Gynex's president.That trial is planned for 24 patients and will be directed byDonald Kotler of St. Luke's/Roosevelt Hospital Center in NewYork. An estimated 10 percent of AIDS patients are diagnosedwith HIV wasting, which is defined by the Centers for DiseaseControl as the loss of at least 10 percent of body weight inotherwise asymptomatic AIDS patients.
Oxandrin, or oxandrolone, is a testorsterone analog that acts onandrogenic receptor sites on muscle cells, spurring theirgrowth. It also has anti-catabolic (anti-wasting) activity at theglucocorticoid receptors on muscle cells. The drug may alsoindirectly stimulate appetite, growth hormone production andpossibly the immune system.
Gynex exclusively licensed oxandrolone from G.D. Searle & Co.Oxandrin is in Phase III clinical studies as a treatment for twopediatric growth disorders, Turner's syndrome andconstitutional delay of growth and puberty. -- Ray Potter
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