Repros' Proellex(R)-V shows consistent efficacy in uterine fibroids phase 2 study (Repros) - Jul 23, 2012 - P2, N=36; NCT01451424; At the end of four months of treatment with Proellex 12 mg, all 7 women stopped menstruating and all reported a PBAC score of 0 (p=0.002); 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); Repros will complete enrollment by the end of this month; Company anticipates full clinical results at or around year end; End of phase 2 meeting with FDA projected for Q1 2013 with advancement to phase 3 thereafter
Anticipated enrollment status • Anticipated FDA event • Anticipated new P3 trial • Anticipated P2 data • P2 data • Endometriosis
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Repros Therapeutics Inc.® (Nasdaq:RPRX) 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
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
Change in fibroid volume determined by MRI was also assessed and a statistically significant (chi square analysis) median reduction of total fibroid volume of 36% was observed.
Planning is complete for the 1 year open label safety study required by the FDA for all NDA submissions. To date, Proellex®-V has been very well tolerated.
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