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.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV