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Enrollment in 6 Month Open Label Study Near Completion
FDA Meeting Request Submitted
Joachim F. Wernicke, Ph.D, M.D., Named Chief Medical Officer
Company to Present at BIO CEO in NYC February 11, 2013
THE WOODLANDS, Texas, Feb. 11, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today provided an update for both of its core clinical programs.
Androxal ® Six Month Open Label Study (ZA-300)
As part of the FDA requirement for total number of subjects to be exposed for six months, the Company is conducting a 500 subject open label study. To date, the Company has enrolled 499 subjects and expects the study to be fully enrolled this week.
Androxal ® Pivotal Studies (ZA-301 and ZA-302)
The Company has sent a "request for guidance" letter to the FDA. The key points were:
The identification of a single high enrolling site with a population whose baseline characteristics appear different from the other sites;
The Company has proposed enrolling an additional 40 subjects into each of the two pivotal studies to allow for subset analysis while retaining the power of the original protocols;
The Company proposed moving two sites from the enrolling study ZA-302 to the closed for enrollment study ZA-301.
When the company receives guidance from FDA, it will update the financial community.
The Company has requested an end of Phase 2 meeting for its vaginal Proellex program for the treatment of uterine fibroids. The request was for a meeting before the end of April 2013.
Joachim F. Wernicke, Ph.D., M.D. named Chief Medical Officer
As part of the Company's endeavors to expand its clinical and regulatory capabilities, Repros has hired Dr. Wernicke as Chief Medical Officer ("CMO"), effective February 5, 2013. Dr. Wernicke joined Eli Lilly and Company ("Lilly") in 1984 and was involved with clinical development and regulatory matters related to Prozac and other central nervous system drugs until 1990. Between 1990 and 1995, he was the VP of Clinical and Regulatory Affairs for Cyberonics, Inc. Thereafter, between 1995 and 1999, he served as a consultant for various pharmaceutical, biotechnology, and medical device companies. In 1999, he rejoined Lilly and was involved in the development and approval of Strattera and Cymbalta. In 2004, he joined the Global Patient Safety group of Lilly and at various times was responsible for Cymbalta, Strattera, Zyprexa, Symbyax, and Effient. He retired from Lilly in 2012.