Normal blood loss in a menstrual cycle is approximately 35 mL. Woman 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 6mg, 12mg and Placebo arms, respectively. One subject dosed at 6mg 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 (18 weeks LOCF), 79% of Proellex®-treated subjects became amenorrheic with no evidence of a dose effect. Two (17%) subjects treated with Placebo had amenorrhea at the end of course 1. The p-value for this comparison is 0.0004. Treatment effect was rapid with 78% of Proellex®-treated subjects became amenorrheic in the first 6 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.
Bleeding was also evaluated by PBAC (Pictorial Blood Assessment Chart). Subjects tallied sanitary product usage and stain size as guided by the chart. Proellex® -treated subjects reported a median 100% reduction (mean 95% reduction) in PBAC scores while Placebo-treated subjects reported a median 62% reduction, further supporting the treatment effect associated with bleeding (p=0.0001).
Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the Proellex®-treated arms by 28% while the Placebo group showed continued increase in size, 3%, p= 0.0007.
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After the first 18 week treatment period, the women were withdrawn from drug to allow for menses.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 5 months.
The Company believes Proellex® suggests a significant advantage over GnRH agonists and antagonists in the treatment of uterine fibroids. Once both the vaginal and oral studies complete both 18 week courses of treatment the Company plans to request an end of Phase 2 meeting with the
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