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158 men currently enrolled in 500 patient 6 month open label study
Repros believes open label study provides encouraging data to support pivotal study endpoint
Repros believes recent financing provides sufficient funds to submit Androxal NDA in 2014
THE WOODLANDS, Texas, Sept. 12, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.
® (Nasdaq:RPRX)today provided a clinical update of its Androxal
® Phase 3 program.
Pivotal Phase 3 Studies
Repros has randomized the first subjects in ZA-301, the first of two pivotal studies. The study is being conducted at various US clinical sites.
The second Phase 3 study, ZA-302, will begin enrollment at many of the same sites after the completion of enrollment in the ZA-301 study. The FDA has agreed that Repros may conduct both identical Phase 3 studies at the same clinical sites as long as the two studies have a distinct principal investigator.
The Company has commenced an advertising campaign this week with the goal of increasing the enrollment rate into the Androxal Phase 3 program. The Company plans to provide an update in the fourth quarter of 2012, to project an estimated last patient last visit date for the first pivotal study and the estimated reporting date of top line results. Currently, the Company believes results from the first study could be available as early as the second quarter of 2013.
About the Pivotal Studies
The two identical pivotal studies are being conducted under a Special Protocol Assessment (SPA) granted by the FDA. The key features of the studies are:
Primary efficacy endpoint; success is defined as at least 75% of Androxal-treated men must achieve 24 hour average testosterone >300 ng/dL at week 12 -- All men in active arm start dosing at 12.5 mg with up-titration to 25 mg at week 6 if morning T remains less than 300 ng/dL -- Primary efficacy to be determined on Intent-to-Treat Population
Primary safety endpoint; comparison of active and placebo arm with respect to the percent of men that exhibit a 50% reduction in sperm counts between two assessments at baseline and two assessments at the end of the active dosing period. The active arm should be non-inferior to placebo.
152 men randomized 3:1 active to placebo
BMI>25 and ≤ 60 years of age
12 week active dosing period
Confirmed baseline morning testosterone levels <300 ng/dL determined on two separate days
Men must be naïve to testosterone treatment or off testosterone therapy for at least 6 months
Confirmed baseline sperm concentrations >15,000,000 sperm/mL determined on two separate days separated by at least 2 days
Six Month Open Label Study (ZA-300)
The Company is conducting a 500 subject open label study to build the size of the safety database to the exposure requirements the FDA has requested for the New Drug Application (NDA). The Company believes it will satisfy the 800 subjects with at least 6 months exposure requirement with ZA-300 and other studies it has already completed or will complete in order to satisfy the requirements for an NDA.