(+) Repros' Proellex-V clears important hurdle in uterine fibroid program (Market Watch) - Apr 30, 2012 - P2, N=36; ZPV-200; Statistical significance (p<0.05) was seen in a pair-wise comparison of the 6 women from both the perspective of reduction in menstrual bleeding using the Pictorial Blood Loss Assessment Chart and a reduction in overall uterine fibroid symptoms as determined by the Uterine Fibroid Symptom Quality of Life Survey; Trial results is expected in the Q4 2012; Company intends to request an end of P2 meeting with the FDA to commence P3 studies late this year or early next year
Anticipated FDA meeting • Anticipated P3 trial initiation • Anticipated trial results • P2 interim data • Uterine Leiomyoma
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-- Vaginal delivery of 12 mg Proellex exhibits the systemic drug exposure designed to optimize risk/benefit clinical profile
-- Encouraging preliminary signs of efficacy in first cohort dosed with 12 mg Proellex-V
-- Animal studies indicate that greater fibroid size reduction will occur at much lower doses of Proellex-V than previously tested oral doses
-- On track for end of Phase 2 meeting with FDA at year end
THE WOODLANDS, Texas, April 30, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.(R) /quotes/zigman/621891/quotes/nls/rprx RPRX +1.66% today announced its Proellex-V, or vaginally delivered Proellex, for the treatment of uterine fibroids, has passed an important first hurdle on the road to registration. Repros is ultimately developing Proellex-V, which is currently in Phase 2 development, for significant fibroid size reduction and symptom elimination, with the goal of avoiding surgery. Approximately 20% of women of reproductive age in the U.S. have symptomatic fibroids, with roughly 300,000 hysterectomies performed annually as a consequence. There is no approved chronic drug therapy for treatment of this debilitating condition.
As agreed upon with the FDA, Repros vaginally dosed 6 women diagnosed with uterine fibroids for a period of 2 weeks to determine steady state pharmacokinetics in order to ensure that overall systemic drug exposure was less than that observed in the previous oral study (1-12 mg). In the oral study, all doses were well tolerated and reliable cessation of menses was induced at doses as low as 3 mg. In earlier clinical studies, cessation of menses has been shown to directly correlate to efficacy in treatment of both uterine fibroids and endometriosis. A vaginal dose of 12 mg achieved only a fraction of the maximum exposure of the ineffective 1 mg oral dose but resulted in cessation of menses in 3 of the women. Statistical significance (pGiven the overall low systemic exposure of the 12 mg dose, the Company believes, in those women that continued to menstruate, reduction of symptoms may further improve with longer exposure to the drug.
The Company has commenced enrolling women into the 3 and 6 mg arms of the study and based on the low exposure of the 12 mg dose has notified the FDA that it will add a fourth cohort at 24 mg to the study. Each arm of the study will enroll 12 subjects. The first three arms of the study should be fully recruited by the end of May with the 24 mg arm enrolled by the end of June. The Company expects to have results from the trial in the fourth quarter of this year. If the study is successful, the Company intends to request an end of Phase 2 meeting with the FDA to commence Phase 3 studies late this year or early next year. In efficacy studies using oral Proellex for the treatment of uterine fibroids, women experienced a nearly 50% reduction in mean fibroid size at a 25 mg dose. When those women were then escalated to a 50 mg oral dose for an additional four months, fibroid size was reduced to approximately 25% of the initial volume. Based on the assessment of fibroid symptoms as scored by UFSQOL, women on oral Proellex were, in general, symptom free. The 12 mg vaginal dose of Proellex is expected to have greater activity than the oral 50 mg dose. Importantly, the 12 mg vaginal dose exhibited a maximum exposure of 1/100th of the 50 mg oral dose. Even with this low exposure after only 4 weeks of treatment, women are seeing significant improvement in their fibroid related condition.
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