Repros expects to report interim data from three studies by year-end

By Angela McDaniels

Seattle, Sept. 5 - Repros Therapeutics Inc. said that based on current enrollment in its three ongoing clinical studies, the company believes it will be able to report top-line, interim data from each study by the end of the year.

The three studies are a 200-patient U.S. phase 3 study of Androxal for the treatment of testosterone deficiency in men with secondary hypogonadism, a 150-patient U.S. phase 2 study of Proellex in the treatment of uterine fibroids and a 40-patient European phase 2 study of Proellex in the treatment of endometriosis.

As of Friday, 133 patients had been enrolled in the phase 3 Androxal study, 88 patients had been randomized in the phase 2 Proellex uterine fibroid study and 87 patients were awaiting randomization and 37 patients have been enrolled in the phase 2 Proellex endometriosis study.

Repros plans to submit protocols to the Food and Drugs Administration to allow patients in the phase 3 Androxal study to roll over into a one-year open-label extension study starting in November and patients in the phase 2 Proellex endometriosis study to roll over into a one-year open-label extension study starting in October. The Woodlands, Texas, pharmaceutical company already submitted a similar protocol to the FDA for the phase 2 Proellex uterine fibroid study, and those patients will begin to roll over into a one-year open-label extension study starting in September.

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