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

t, no statistically significant changes in endometrial thickness were detected among the women who underwent ultrasound measurements of endometrial thickness at various time points. This study uses an endometrial thickness cut-off of 14mm after three months of dosing to determine whether or not a woman is allowed to proceed into an ongoing open label study. For those patients that were evaluated 9 patients at the 12.5 mg dose and 4 patients at the 25 mg dose exhibited an endometrium greater than 14 mm compared to 6 patients on placebo. An expert panel of pathologists will review all of the biopsies using the WHO criteria in addition to a specific classification created for the analysis of the histology in this study. Fifty-eight patients have rolled into a one-year open label extension study.

All reproductive hormones remained in the normal range and there is no indication of bone loss using evaluating markers of bone resorption. In fact, there was a statistically significant increase in osteocalcin in the two Proellex groups. Osteocalcin is a marker associated with bone formation. In addition there was no change in urinary 24 hour cortisol excretion or serum adrenocorticotropic hormone (ACTH) indicating a lack of antiglucocorticoid activity at the receptor level.

Both doses of Proellex were well tolerated. The number of adverse events judged to be treatment related by the investigators in the Proellex 12.5 and 25 mg treatment groups were similar in incidence to placebo. The exception was the occurrence of amenorrhea (an expected drug effect) in 78.6% and hot flashes in 16.7% of all Proellex treated patients, respectively. The hot flashes were not dose dependent. The severity of the hot flashes was generally mild to moderate as were the vast majority of the other adverse events. On average, there were no clinically significant changes in other laboratory measurements of safety including liver enzymes.

"We are very pleased with these results," co
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