Roberta Friedman, Ph.D.Special to BioWorld
Gynex Inc. has won orphan drug designation from the Food andDrug Administration for its metabolic stimulant as an adjunctto AIDS therapy.
Robert Dudley, vice president for research and development,told BioWorld that the company hopes to begin by the end ofthe year human trials of Oxandrin for the wasting syndromethat often accompanies AIDS.
The Vernon Hills, Ill., company has obtained from G.D. Searle &Co. exclusive rights to the anabolic steroid, which in animaland human studies has shown the ability to build muscle massin disease states. Wasting of muscle might be reversed in AIDSas well, Dudley said.
Other potential applications for the steroid include Turner'sSyndrome in girls and constitutionally delayed growth inchildren, which are also potential targets of recombinanthuman growth hormone. But according to Dudley, Oxandrincosts a tenth as much and is active orally.
Substantial clinical data already exists for the steroid's valuein these children's markets, Dudley said, which could bring inincome while Gynex pursues the AIDS use. The company expectsto file for approval of the steroid for Turner's by 1993.
Searle has agreed to manufacture the drug for Gynexexclusively for the next 10 years, with Gynex owning exclusiverights to market in the United States and 22 other countries.Orphan drug designation will give Gynex certain tax crdits andseven years of exclusive marketing following FDA marketingapproval.
(c) 1997 American Health Consultants. All rights reserved.