FDA Places Repros Proellex® On Clinical Hold

THE WOODLANDS, Texas -- Repros Therapeutics Inc. (NasdaqGM:RPRX) received verbal notice on August 4, 2009 from the United States Food and Drug Administration (FDA) that it’s Investigational New Drug Applications (INDs) for Proellex have been placed on clinical hold for safety reasons. This action follows Repros' recent voluntary decision to suspend dosing of all patients in its clinical trials of Proellex.

Repros and the FDA are scheduled to discuss the safety of Proellex and the overall direction and scope of the clinical trials of Proellex at a meeting in late September. The FDA requested that the company provide it with weekly updates about the patients who experienced a serious adverse event and still have elevated liver enzymes.

In addition, at the September meeting Repros intends to present a detailed analysis of all of the patients with elevated liver enzymes, discuss the events that led to the suspension of the clinical trials, and determine whether and under which conditions, if any, the clinical hold may be lifted and the clinical trials of Proellex be safely resumed.

Source: Repros Therapeutics, Inc.