Repros Therapeutics Inc. has been given a verbal go-ahead from the U.S. Food and Drug Administration to initiate its investigational new drug application for the study of its male infertility drug Androxal in the treatment of men with Type II diabetes.
The Woodlands-based Repros (NASDAQ: RPRX) plans to enroll a total of 60 men into Phase IIa clinical trials to compare the reactions to a placebo to two active doses of the drug.
Dr. Glenn Cunningham, a professor at Baylor College of Medicine, will lead the trials.
Androxal is being developed for the treatment of secondary hypogonadism, or a defect of the gonads that results in the underproduction of testosterone.
Repros Chief Executive Officer Joseph Podolski said that the company must raise additional capital before it can actually move forward with the study. The company faced bankruptcy last year as its cash position dwindled.
Previous studies had found that men taking Androxal were more susceptible to hypoglycemia.
“The retrospective analysis from our previous study is interesting. However we should not underestimate the challenges in conducting studies in diabetes,” Podolski said. “We believe the protocol we have designed will determine if there is clinically significant signal that warrants further development.”
Last week, Repros received advice from the FDA on how to advance Androxal’s regulatory process.
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