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Repros Therapeutics
Inc.^®
earlier 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.
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.
Conference Call Details:
Time: Monday, January 28, 2013 – 8AM Eastern
Participant Dial In Number: 877-407-0782
International callers: 201-689-8567
Participant Title: Repros Therapeutics
Teleconference Replay will be available until February 4, 2013.
Replay Number: 877-660-6853, Conference ID#: 408375
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