Repros' Proellex(R)-V Shows Consistent Efficacy in Uterine Fibroids Phase 2 Study

Repros Therapeutics Inc.®

today announced it will complete enrollment in its Proellex®-V, or vaginally delivered Proellex® Phase 2 study in the treatment of uterine fibroids at the end of this month. The Company believes it will be able to report study results near year end with the goal to move to Phase 3 early next year. The first 7 subjects at the 12 mg dose have completed 4 months of treatment in the single blind study. During the placebo run in phase the mean menstrual blood loss as determined by the Pictorial Blood Loss Assessment Chart (PBAC) was 117.7 mL (st.dev. 80.7). At the end of four months of treatment all 7 women stopped menstruating and all reported a PBAC score of 0 (p=0.002). At the same time there was a statistically significant and highly clinical meaningful reduction in Uterine Fibroid Symptom Quality of Life Survey (UFSQOL) scores. The mean UFSQOL score at baseline was 43.8 and at the end of four months the mean score was 1.33 (p=0.001). Both bleeding and bulk related symptoms assessed by the UFSQOL were dramatically reduced with 6 of 7 subjects responding they no longer experienced any fibroid related symptoms. To put the UFSQOL scores in perspective, women with fibroids typically score 40 or higher, whereas women without fibroids report scores of approximately 20. The one woman that reported fatigue had a total score of 9.4.