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News Breaks | | | | January 28, 2013 | | 06:58 EDT |  | RPRX | Repros Therapeutics to now release clinical results from trial of Androxal in Q3
Repros Therapeutics 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 instead of Q2. 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. The company is attempting to schedule a meeting with the FDA to advise the Agency of Repros' plan. Repros believes this outcome will not affect the timing of the NDA submission currently targeted for mid-2014. | |
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News For RPRX From The Last 14 Days Check below for free stories on RPRX the last two weeks. |
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| May 22, 2013 | | 20:03 EDT | | RPRX | Repros Therapeutics says FDA recommends Phase 2b trial of Proellex-V
Repros Therapeutics announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the treatment of uterine fibroids. The FDA recommended that a Phase 2b study should be conducted as a prelude to the Phase 3 program. The study will start in the latter half of this year and results are expected in mid-2014. The FDA also felt the studies should be one year in duration. The company was already planning large one year safety studies as part of its overall clinical package. NDA submission is expected in 2016. The outcome of the meeting does not materially affect the cost of the total development program, but it does reduce the cash requirements for Repros through 1Q14. | | | May 10, 2013 | | 09:26 EDT |  | RPRX | Repros Therapeutics reports Q1 EPS (41c), consensus (35c)
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