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Timing for NDA submission still planned for mid-2014
Conference call at 8 AM ET on Monday, January 28, 2013
THE WOODLANDS, Texas, Jan. 28, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.
® (Nasdaq:RPRX) today provided a revised date for expected clinical results from the first pivotal study, ZA-301, of Androxal
® in the treatment of secondary hypogonadism. The Company now plans to provide the data in Q3 2013 instead of Q2 2013.
During the ongoing review of the data it was determined that one site's patient population was markedly different from the other 16 sites from the standpoint of baseline sperm counts. The site in question had enrolled 40 subjects into the 151 subject trial. Though the subjects at the site meet the strict entry criteria for the trial, the clear difference from the other sites begs the question of whether or not this site represents the general population to be treated or is, in fact, a special population. To that end, the Company felt it would be prudent to remove the site from the efficacy studies and replace the subjects with those enrolled at other sites. Preliminary blinded analysis of reported subjects from the identified site indicates these subjects have responded as well or better than the other sites from the standpoints of improved testosterone and maintenance of sperm concentration.
Fortunately, the Company is enrolling subjects into the identical pivotal trial ZA-302. The current plan, pending regulatory approval, is to move already enrolled subjects from sites in ZA-302 to ZA-301 to make up the shortfall. Since many of these subjects have recently been enrolled, it will extend the time before the data base from the first study can be locked and analyzed. The Company believes it can have the data available for top line release in Q3 of this year.