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Repros reports positive clinical data for oral Proellex
THE WOODLANDS, Texas—May 18 saw Repros Therapeutics Inc. report that oral administration of Proellex at doses of both 6 mg and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.
Normal blood loss in a menstrual cycle is approximately 35 mL. Women experiencing blood loss of >80 mL are considered to suffer from menorrhagia or excessive menstrual bleeding. In this Phase 2b study, 12, 17 and 14 women with confirmed uterine fibroids were enrolled in the 6 mg, 12 mg and placebo arms, respectively. One subject dosed at 6 mg and one placebo-treated subject were discontinued as they did not meet entry criteria, and thus were not eligible for efficacy analysis. At baseline, the mean amount of blood lost for one menstrual cycle was 177 mL, 251 mL and 260 mL for each arm, respectively. The blood loss ranged from a low of 82 mL to a high of 769 mL. Blood loss was determined by collecting all sanitary products used from an individual and then an alkaline hematin assay was performed to estimate the actual amount of blood collected in the pads.
When a sufficient concentration of Proellex is achieved in circulation, amenorrhea (cessation of menses) is achieved. At the end of the first course of treatment, 79 percent of Proellex-treated subjects became amenorrheic with no evidence of a dose effect. Two (17 percent) subjects treated with placebo had amenorrhea at the end of the first course. The p-value for this comparison is 0.0004. Treatment effect was rapid, with 78 percent of Proellex-treated subjects became amenorrheic in the first six weeks of treatment. Bleeding diaries consistently report a statistically significant difference in the number of days of bleeding and bleeding intensity between those treated with Proellex and placebo.
Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the Proellex-treated arms by 28 percent while the placebo group showed continued increase in size.
The drug was generally well tolerated. Women in the drug arms continued to exhibit levels of estradiol consistent with bone preservation.
After the first 18-week treatment period, the women were withdrawn from drug to allow for menses. The women in the study are currently being treated with the second course of treatment for another 18 weeks. The study treatment assignment remains blinded to the subjects, physicians and those managing the study and data. The results of the second course of treatment should be reported within the next five months.
The company believes Proellex suggests a significant advantage over GnRH agonists and antagonists in the treatment of uterine fibroids.
SOURCE: Repros news release