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To date there has been noevidence for an increase in efficacy at the 50 mg dose

June 17, 2010 Health No Comments

To date, there has been noevidence for an increase in efficacy at the 50 mg dose. In addition, earlierstudies have demonstrated highly effective control of excessive menstrualbleeding and clinically significant improvement in quality of life parameters atthe lower doses of 12.5 and 25 mg. To further support the efficacy of the lower doses of Proellex, Repros will alsoinitiate additional placebo-controlled studies with the 12.5 mg dose tosupplement the overall efficacy and safety profile of the drug in theseimportant indications. From completed studies as well as from theongoing large open label trial, it has been determined that the drug is welltolerated with few women discontinuing treatment due to adverse events. Repros believes that the decision to discontinue the higher dose will mostlikely improve the benefit/risk profile of the drug. To date, Repros has dosed over600 patients, and over 200 patients have completed at least one dosing periodfollowed by an off-drug interval.

The study showed noefficacy differences between the 25 mg and 50 mg doses. At the upcoming end of Phase II meeting, Repros anticipates obtaining directionfrom the FDA on the objectives and endpoints the Agency would like to see usedin the pivotal phase III efficacy and safety studies in endometriosis. Reprosplans to initiate these studies with doses of 12.5 and 25 mg during the fourthquarter of this year and the first quarter 2010, in both the United States andin Europe. Furthermore, Repros has decided to discontinue the use of the higher, 50 mg dosein its ongoing studies in women with chronic symptomatic uterine fibroids andanemia associated with this condition due to an observed dose-dependent increasein liver enzymes in a low percentage of women.

Sunset Development CompanyEd Hagopian, orJStokesDan Stokes, Copyright Business Wire 2009. THE WOODLANDS, Texas–(Business Wire)–Repros Therapeutics (NasdaqGM:RPRX) announced today that an end of Phase IImeeting is scheduled with the Food and Drug Administration (“FDA”) for lateSeptember 2009 to discuss a Phase III program investigating the use of Proellexin the treatment of endometriosis. The Phase II study that Repros completed earlier this year demonstratedclinically and statistically significant reductions of the three key painsymptoms commonly experienced by women with endometriosis: dysmenorrhea (painfulmenses), non-menstrual pelvic pain, and dyspareunia (painful intercourse).Additionally, the reduction of pain was accompanied by a statisticallysignificant reduction in the number of patients requiring pain medication inboth doses in this Phase II study compared with placebo. The Bank operates more than 700 branchlocations and commercial banking offices in 19 Western and Midwestern states.Bank of the West’s holding company, BancWest Corporation, is a subsidiary of BNPParibas, among the six strongest banks in the world, according to Standard &Poor’s. It is home to over 550 companies and their more than 30,000employees. The business park includes corporate office space to several Fortune1,000 companies, as well as dining, shopping and hotel accommodations.

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