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Aug 3, 2009

Repros Ceases All Clinical Studies in Endometriosis due to Increased Liver Enzyme Levels

  • Repros Therapeutics is suspending dosing of all patients in its clinical trials of Proellex due to increases in liver enzymes seen in patients. A previously scheduled meeting for late September with the FDA to discuss end of Phase II trials will now instead assess the safety of this endometriosis treatment and overall direction and scope of the program.

    The news sent the company’s stock into a downward spiral. The firm opened trading today at $1.05 after closing Friday at $2.50, a 58% decrease. Repros reports that it is considering various financing alternatives to address its immediate short-term liquidity needs.

    All ongoing clinical trials with Proellex will be halted, including investigations of the drug as a treatment of chronic symptomatic uterine fibroids (Phase III initiated), anemia associated with this condition (Phase III initiated), and endometriosis (Phase II).

    More than 600 patients participated in double-blind and open-label clinical trials with exposure to placebo or various doses of Proellex for more than one month. Approximately 500 received Proellex: about 190 received a dose of 50 mg per day; roughly 260 received a dose of 25 mg per day; and 55 received a dose of 12.5 mg per day. Thirteen subjects, all on Proellex, had an increase in liver enzymes greater than three times the upper limit of normal. Repros says that this was confirmed in nine of these subjects. All patients are being closely watched, and as of July 27, five still had elevated enzymes.

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