Gynex Pharmaceuticals Inc. has received Food and DrugAdministration approval to begin supplying the steroidoxandrolone for treating delayed growth in boys while the drugis still in Phase III clinical testing for that use.

Under the treatment investigational new drug (IND) approval,Gynex can now supply the drug on a physician's order andcharge for the cost of production, distribution and research, inaddition to its use in the clinical trial at no charge.

A year's therapy of Oxandrin, which the Vernon Hills, Ill.,company has licensed exclusively from G.D. Searle & Co., willcost $1,000 to $2,000. Gynex President Stephen Simes said thecharge "is pretty inexpensive compared to other treatment INDdrugs, and certainly to growth hormone." The company said ithopes that insurance will cover the cost for patients.

Simes estimated that one-third of boys with constitutionaldelay of growth and puberty are treated by doctors.

Girls with Turner's syndrome, who are short because they aremissing an X chromosome, are also receiving oxandrolone andrecombinant growth hormone in clinical trials.

Gynex has won orphan drug status for oxandrolone for use as ametabolic stimulant in AIDS, and for its use in Turner's. Thecompany expects to file for approval of Oxandrin for Turner'sby 1993, and plans to start testing it in AIDS patients by theend of this year. Gynex stock (NASDAQ:GYNX) on Wednesdayclosed at 94 cents, down 13 cents. -- Roberta Friedman, Ph.D.

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