Repros Therapeutics requests Type B Meeting to review Androxal Phase III protocols

Aug 18 2010

Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company has requested a Type B Meeting in order to review the Company's Phase III protocols for Androxal^® in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

“normalization of serum testosterone levels while preserving fertility.”

Larry I. Lipshultz, MD, Baylor College of Medicine, Professor, Scott Department of Urology, Lester and Sue Smith Chair in Reproductive Medicine, and Past President, American Society for Reproductive Medicine has agreed to serve as Lead Investigator for the Company's Phase III program and will help Repros in preparing the pivotal protocols. The studies are being designed to show that only Androxal normalizes both testosterone and sperm concentrations as compared to topical testosterone or placebo. In a small pilot study previously conducted by Repros, only Androxal resulted in normalization of both testosterone and sperm counts in a majority of subjects. In this population of men that previously used a topical testosterone, no men on testosterone or placebo exhibited normal concentrations for both measures. Per FDA recommendation, benefit will be determined by "normalization of serum testosterone levels while preserving fertility."

Dr. Lipshultz commented, "In an era when increasingly more men are turning to testosterone replacement therapy for treatment of their low testosterone, it is important to many of these men to be able to maintain normal sperm production (spermatogenesis). Androxal has the potential to play an important role in helping to maintain normal sperm production in those men for whom testosterone replacement therapy is their best treatment and for whom the maintenance of normal spermatogenesis is equally as important."