Actionable news
All posts from Actionable news
Actionable news in RPRX: Repros Therapeutics Inc.,

The Woodlands, Texas, April 12, 2016 (Globe Newswire) — Repros Therapeutics Inc

The following excerpt is from the company's SEC filing.

(Nasdaq:RPRX) today reported that vaginal administration of Proellex

at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.

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%...