Gynex Inc. announced Monday it will conduct a Phase IIIclinical trial of Oxandrin to treat Turner syndrome under a$220,000 grant from the Food and Drug Administration.
Turner syndrome girls are short-statured and do not developovaries because they have only one functional X chromosome.Normal girls have two X chromosomes. About 800 girls areborn each year with Turner syndrome.
Oxandrin, or oxandrolone, is a testosterone analog thatpromotes growth in Turner syndrome girls. Gynex is alsotesting Oxandrin in boys with constitutional delay of growthand puberty.
Oxandrin promotes growth as effectively as growth hormone atone-tenth the cost, Stephen Simes, Gynex's president, toldBioWorld. The company estimates that Turner syndrome girlswould need the therapy starting at 11 years and continuinguntil about age 16. The company is also testing low doses ofestrogen in Turner syndrome girls to stimulate sexualdevelopment.
Gynex, founded in 1983, obtained exclusive rights tooxandrolone from G.D. Searle & Co. after low sales caused Searleto stop marketing the drug in 1989. Searle had sold the drug asan anabolic agent for post-surgery or cancer patients. Pediatricendocrinologists contacted Gynex to develop the drug forTurner syndrome and constitutional delay of growth andpuberty, said Simes.
The Vernon Hills, Ill., company expects to file a new drugapplication for the use of Oxandrin to treat Turner syndromeby 1993, Simes added. Gynex (NASDAQ:GYNX), which currentlyhas no products in the marketplace, plans to sell Oxandrindirectly to the 400 to 500 pediatric endocrinologists in theUnited States.
The FDA awarded the grant under its Orphan Drug Program.The multicenter, placebo-controlled, study of 80 Turnersyndrome girls will begin this summer under the direction ofDr. Jo Anne Brasel at Harbor-UCLA Medical Center.
-- Carol Talkington Verser, Ph.D. Special to BioWorld
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