Normal menstrual 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 small Phase 2b study, 13, 15 and 14 women with confirmed uterine fibroids were enrolled in the 6mg, 12mg and placebo arms, respectively. At baseline, the mean amount of blood lost for one menstrual cycle was 255 mL, 274 mL and 238 mL for each arm, respectively. The blood loss ranged from a low of 94 mL to a high of 654 mL. The most severe menstrual bleeding at baseline was observed in the 12 mg group. 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. Just over half, 52%, of Proellex®-treated subjects became amenorrheic with no evidence of a dose effect. All subjects treated with Placebo continued to menstruate throughout the 18 week dosing period. The p-value for this comparison is 0.0011. 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 in PBAC scores while Placebo-treated subjects reported a 25.4% reduction, further supporting the treatment affect associated with bleeding (p=0.0033).
Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the Proellex®-treated arms by 18% while the Placebo group showed continued increase in size, p= 0.0437.
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After the first 18 week treatment period, the women were withdrawn from drug to allow for menses.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® represents 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
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as "may," "will," "expect," "anticipate," "continue," "estimate," "project," "intend," "believe," "plan," "seek," "could," "can," "should" or similar expressions. These statements are based on assumptions that the Company has made in light of the Company's experience in the industry, as well as the Company's perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to ongoing and future clinical studies and the timing and results
thereof, the Company's plans to communicate with the
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CONTACT: Investor Relations:
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