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Repros' Proellex Shows Statistically Significant Improvement in,Primary Endpoint in Phase 2 Trial in the Treatment of Uterine,Fibroids

THE WOODLANDS, Texas--(BUSINESS WIRE)--Apr 3, 2007 - Repros Therapeutics Inc. (NasdaqGM:RPRX) announced final results of a U.S. Phase 2 study of Proellex(TM), an oral drug being developed to relieve symptoms of uterine fibroids. This study suggests that treatment with Proellex results in a statistically highly significant improvement in symptoms associated with uterine fibroids and is generally well tolerated.

Study Details and Results

This 12 week, double-blind study compared two doses of Proellex, 12.5mg and 25mg, to placebo. The study's primary endpoint was reduction in excessive menstrual bleeding, a common symptom of uterine fibroids. This endpoint was assessed using a validated visual analog scale known as the Pictorial Blood Loss Assessment Chart (PBAC). Pain associated with fibroids was assessed using a well validated tool, the McGill pain score, and various other symptoms associated with fibroids were assessed using the validated Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire.

Of the 127 patients enrolled in the trial, 96 patients completed the study. There were 8 premature drop outs in each of the two Proellex arms of the study and 15 drop outs in the placebo arm. There were two drop outs due to an adverse event in the high dose group as well as one in both the low dose and placebo arm. The majority of the other drop outs were due to either withdrawal of consent or "lost to follow-up". The modified intent-to-treat group consists of 114 patients.

Women on Proellex experienced a dramatic reduction in PBAC from mean scores of over 100 to scores less than 10. The mean scores after three months of dosing for the 25mg and 12.5mg dose of Proellex were 6.0 and 16.9, respectively. Women on placebo, on the other hand, exhibited a score of 109.5 after 3 months of treatment. The 12.5mg and 25mg doses were statistically superior to placebo with p-values of less than 0.0001
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