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Statistically Significant Signals of Efficacy Observed in 1 mg Dose
No Drug Related Emergent Adverse Events at 1 mg Proellex After 10 Weeks of Continuous Dosing
THE WOODLANDS, Texas, March 15, 2011 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. (Nasdaq:RPRX) today announced it has completed its internal review of the results obtained for the 1 mg dose from its low dose study of Proellex
®. No signals of liver toxicity or drug related adverse events were detected over the 10 week dosing period. Twelve women were enrolled in the study and 11 women completed the trial. The one woman that discontinued left the study because she was not able to visit the clinical site weekly, as prescribed by the protocol.
Proellex is an oral therapy in development for the treatment of uterine fibroids and endometriosis. Large Phase III clinical studies exhibited severe liver toxicity in a small percentage of subjects that were exposed to the 50 mg dose. As a result of these observations, the program was placed on full clinical hold until the phenomenon could be better understood. After an analysis of all the subjects that had been exposed to Proellex, Repros petitioned the FDA to allow the Company to conduct a low dose trial to assess impact on the liver and signals of efficacy. In the summer of 2010 the FDA moved Proellex to partial hold status to allow for the low dose study.
The trial is enrolling up to 12 subjects per cohort. One of the first signals of efficacy for Proellex is induction of amenorrhea. This has profound effects on symptoms of both uterine fibroids and endometriosis. In the final analysis of the 1 mg group 5 out of 11 women stopped menstruating while taking the drug. This shift compared to the placebo phase of the study reached near statistical significance p=0.07 in this very small study. When changes in recorded bleeding intensity for each cycle was assessed, comparing the drug to the placebo period, a highly statistically significant outcome was observed p=0.004.