Repros to Conduct US Study for Proellex
Posted on: Friday, 14 September 2007, 09:00 CDT
Repros Therapeutics has been cleared by the FDA to conduct a US study assessing Proellex in the improvement of symptoms associated with endometriosis.
The Texas-based biopharmaceutical company said that its investigational new drug (IND) application for the US study of Proellex became effective on September 10, 2007. The first study conducted under the new IND will be a Phase II trial that will enroll 75 patients at up to 20 clinical sites in the US.
The study, to be conducted by Compleware Corporation, is designed to assess the improvement of symptoms associated with endometriosis. The trial will test two doses of Proellex, 25mg and 50mg, as a once-a-day oral therapy, versus placebo in a double-blind design. The study is of 16-week duration.
The patients will also be monitored for changes in the condition of the endometrium, or lining of the uterus. The four-month duration of the trial is consistent with the duration of treatment deduced from previously conducted trials with Proellex. After the treatment period, patients will be followed up to observe for a return of symptoms.
An open label extension study for the patients enrolled in the trial will be submitted under a separate protocol. If accepted, the extension study will allow for patients to be treated for two additional four-month cycles with an intervening menstruation between each cycle.
Dr Andre van As, CMO, said: "The previously conducted study of the use of Proellex in the treatment of the pain symptoms associated with endometriosis gave a clear and strong efficacy signal. We believe those findings will extend to the outcomes we hope to observe in this trial.
"Our recently described treatment paradigm of sequential four-month treatment cycles each followed by a drug holiday is now in place for all of our studies. This holiday, which allows the endometrium to refresh, is being employed in our ongoing open-label extension study of Proellex in the treatment of uterine fibroids."
Source: Datamonitor
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