Vaginal Proellex telapristone: Additional Phase II data

Data from 31 evaluable women diagnosed with uterine fibroids in the single-blind, placebo-controlled, U.S. Phase II ZPV-200 trial showed that once-daily 12 mg vaginal Proellex given for 12 weeks led to significant reductions from baseline in mean percent change in PBAC menstrual bleeding, overall uterine fibroid symptoms as determined by UFSQOL and fibroid volume vs. pooled data from the 3 and 6 mg dose groups (p<0.05 for all). Specifically, PBAC menstrual bleeding was reduced from baseline by 58.3% in the 3 mg arm, 56.8% in the 6 mg arm, 84.6% in the 12 mg arm and 85.5% in the 24 mg arm. Reductions in overall uterine fibroid symptoms were 59.3% for the 3 mg arm, 6.5% for the 6 mg arm, 79.1% for the 12 mg arm and 65% for the 24 mg arm. Additionally, mean percent changes in fibroid volume were an increase of 1% for the 3 mg arm, a reduction of 3.1% for the 6 mg arm and a reduction of 28% for the 12 mg arm (p=0.002 and p=0.01 for the 12 mg arm compared to the 3 and 6 mg arms, respectively). Data for the mean percent change in fibroid volume for the 24 mg dose group are not yet available. One patient in the 6 mg arm exhibited continuous uterine bleeding.

Cessation of menses occurred in 58% of patients receiving the 12 mg dose vs. 18% of the patients receiving either the 3 or 6 mg doses. Repros said it believes incomplete cessation of menses at the 12 mg dose was a result of poor compliance. The company also said the 24 mg dose unexpectedly exhibited lower exposure than the 12 mg dose. The company therefore plans to pursue the 12 mg dose in Phase III testing. The trial enrolled 40 patients in 4 cohorts to receive 3, 6, 12 or 24 mg Proellex. Fifteen patients have enrolled in a 1-year extension study. Repros plans to request an end-of-Phase II meeting with FDA this quarter. ...