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

for both. These results were similar for both the modified intent-to-treat group and the group of patients that completed the study. A positive effect of reducing menstrual blood loss was a significant increase in hemoglobin in the Proellex treated group as a whole but particularly in those subjects with an abnormally low hemoglobin on study entry.

Women treated with 12.5mg and 25mg of Proellex for three months also experienced an overall highly statistically significant reduction in symptoms associated with uterine fibroids compared to the placebo group. After three months of treatment women on the 12.5 and 25 mg doses of Proellex had scores of 17.4 and 14.9 respectively compared to 40.1 for the placebo group. Other quality of life domains in the validated scale used in this trial included concern, activities, energy/mood, control, self-consciousness and sexual function. The high dose of Proellex achieved statistically significant improvements (p less than 0.05) versus placebo in all sub-domains.

Though not a primary endpoint, roughly 60% of the women in the study experienced pain as a symptom associated with uterine fibroids. When compared to baseline, women on Proellex experienced a statistically significant reduction in McGill pain scores for both the 25mg and 12.5mg dose. Of the women that experienced pain at baseline, 44.4% of women on the 25mg dose and 29.2% of women on the 12.5 mg dose became pain free while on the drug compared to 18.2% of women on placebo.

The effects on fibroid size were also measured but due to potential site to site variability no consistent dose dependent effects were observed. A separate assessment by a single reader will be attempted at a later date using the source documents generated in the trial. Though this effect is not considered a primary endpoint, effects on fibroid size are of interest to practitioners. In future studies where size is an endpoint MRI's will be used.

After three months on treatmen
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