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GYNEX PHARMACEUTICALS ANNOUNCES FIRST ORAL DRUG FOR TURNER SYNDROME

 VERNON HILLS, Ill., Dec. 16 /PRNewswire/ -- Gynex Pharmaceuticals Inc. (NASDAQ: GYNX) today announced that Oxandrin(TM) (oxandrolone), the first oral drug for increasing growth rates in girls with Turner syndrome, is now in clinical trial and available under a U.S. Food and Drug Administration (FDA) approved Treatment IND. Turner syndrome is a common genetic disorder that causes short stature, lack of sexual development and other complications. There currently is no approved therapy for treating Turner syndrome in the United States.
 Studies Indicate Oxandrin Dramatically Improves Growth Rate
 "Oxandrin has a well-documented history of use for growth disorders by pediatric endocrinologists," said Dr. Robert Dudley, Gynex vice president of research and development. "We are happy to provide immediate help to girls with Turner syndrome who don't qualify for or choose not to participate in our ongoing placebo controlled Phase III clinical trial. Importantly, we hope this will encourage the enrollment of additional patients in the controlled trial. Our first priority is to complete enrollment in order to provide controlled clinical data to the FDA for review."
 In published clinical studies, Oxandrin has been reported to dramatically improve the rate of growth in Turner syndrome patients. When used in combination with human growth hormone, published studies suggest greater increases in growth rate than when either compound is used alone.
 Oxandrin Tablets Are Fraction of Cost of Growth Hormone Injections
 Unlike growth hormone, which must be administered by injection, Oxandrin is a tablet and available at a substantially lower cost. Oxandrin therapy costs less than $2,000 per year, compared with $15,000 to $30,000 for the injectable growth hormone.
 Treatment IND Makes Oxandrin Available While Clinical Trials Proceed
 The FDA Treatment IND is a special procedure designed to provide access to potential new drugs for serious conditions prior to the completion of controlled clinical trials. Under Treatment INDs, Oxandrin now can be prescribed as part of open clinical studies either for Turner syndrome or constitutional delay of growth and puberty (CDGP) by pediatric endocrinologists or other physicians with experience in treating growth disorders. The Treatment IND allows Gynex to charge for the drug in order to recover the cost of production, distribution and research of Oxandrin when supplied to patients with Turner syndrome or CDGP.
 A multicenter, placebo-controlled Phase III clinical trial of Oxandrin for Turner syndrome is in progress under the direction of Dr. Jo Anne Brasel, professor of pediatrics and chief of pediatric endocrinology at Harbor-UCLA Medical Center in Torrance, Calif. Enrollment for this clinical trial is still open and physicians are encouraged to enroll their qualifying patients immediately.
 A fully enrolled, multi-center, placebo-controlled Phase III clinical trial of Oxandrin for CDGP is in progress under the direction of Dr. Darrell Wilson, assistant professor of pediatrics at Stanford University Medical Center, Stanford, Calif. CDGP commonly is diagnosed when the height, pubertal development and bone age of an otherwise healthy adolescent are significantly below average for his chronological age. The condition often is associated with a family history of delayed puberty.
 Gynex plans to submit New Drug Applications (NDAs) to the FDA for these indications beginning in 1993, as controlled clinical trials are completed.
 Physician Information
 Physicians interested in information on how to enroll their patients in the placebo-controlled Turner syndrome trial or under the Treatment INDs should contact:
 Dr. Robert Dudley
 Gynex Pharmaceuticals, Inc.
 1175 Corporate Woods Parkway
 Vernon Hills, Ill. 60061
 708-913-1144
 Gynex Pharmaceuticals Inc. develops and markets products for use in endocrinology, urology, metabolism, AIDS and gynecology.
 -0- 12/16/92
 /CONTACT: Stephen M. Simes of Gynex, 708-913-1144; or Lynne Franklin, Financial Relations Board, 312-266-7800/
 (GYNX)


CO: Gynex Pharmaceuticals Inc. ST: California IN: MTC SU:

EH -- LA024 -- 7783 12/16/92 13:57 EST
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Date:Dec 16, 1992
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