Repros Therapeutics Suspends Dosing Of Proellex

Repros Therapeutics, in the interest of patient safety, has voluntarily suspended dosing of all patients in its clinical trials of Proellex.

The decision is based on available information regarding the occurrence of significant increases in liver enzymes with 50mg and 25mg doses of Proellex, coupled with recent input from a consulting panel of liver experts.

The company submitted a meeting request to the FDA on July 30, 2009. In response, FDA has proposed to change the topic of the previously scheduled ‘End of Phase II’ meeting for endometriosis in late September, into a discussion about the safety of Proellex and overall direction and scope of the program.

The suspension of dosing would involve all ongoing clinical trials with Proellex for the treatment of chronic symptomatic uterine fibroids, anemia associated with this condition, and endometriosis. All of the patients in these trials were receiving a dose of 25mg per day, said the company.

Previously, Repros informed the clinical research organizations (CROs) running the clinical trials to switch all patients who had been receiving 50mg per day in the ongoing clinical trials, to the 25mg dose. The 12.5mg dose had been previously studied in earlier phase II uterine fibroid and endometriosis trials, but no patients were receiving 12.5mg per day in any trial at the time dosing was discontinued, said the company.