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Repros Announces Positive Initial Findings on Proellex

Published 05/29/2008

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No Adverse Effects on the Endometrium after One Year on Drug

THE WOODLANDS, Texas -- Repros Therapeutics Inc. (NasdaqGM:RPRX) has released encouraging results from its one-year extension safety study of Proellex in the chronic treatment of the symptoms associated with uterine fibroids. To date there have been no findings of abnormal endometrial biopsies post menses after cessation of administration of drug.

Repros has developed a unique approach to dosing with Proellex which treats women for four months (16 weeks) and then stops treatment to create an “off drug interval” until the next menstrual period commences and then recommences treatment for four months. These cyclical treatments are designed to be used for chronic treatment of symptomatic uterine fibroids. The rationale for this treatment regimen is that most of the reported bleeding events in previous studies occurred after 16 weeks of continuous treatment and were accompanied by endometrial thickening. By allowing a menstrual flow to occur after treatment withdrawal, the endometrium would be refreshed and the tendency toward a progressive endometrial thickening would be eliminated.

In a statement, Joseph S. Podolski commented, “These early findings further convince us of the utility and safety of Proellex in the treatment of significant female disorders. These are early findings. However, the consistency of endometrial effects both while on drug and following menses post prolonged exposure support our “off drug interval” approach going forward. We look to share our observations with our shareholders and the scientific community as more data becomes available.”

About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders. For more information please visit the company's Web site

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