Zonagen to begin study of Proellex for uterine fibroids

By Angela McDaniels

Seattle, Dec. 15 - Zonagen Inc. said it has received permission from the Food and Drug Administration to begin the phase 2 study of its drug Proellex. The study will enroll 150 patients at up to 20 clinical sites in the United States.

The 150-patient study is designed to assess both improvement of symptoms associated with uterine fibroids and the effects of Proellex on the fibroid itself.

Pharm-Olam International Ltd will lead the study and test two doses of Proellex versus placebo in a double-blind design for 12-weeks.

Doses to be used in this trial were previously tested in a 30-patient, 12-week European study in women with uterine fibroids.

The once-a-day oral therapy exhibited positive effects on fibroid size, bleeding and pain associated with the condition, the company said, and was well tolerated over the course of the study.

Proellex is being developed to alleviate symptoms associated with both uterine fibroids and endometriosis by selectively blocking the progesterone receptor in women.

As many as 80% of all women in the United States have uterine fibroids, the company said, and one in four of these women have symptoms severe enough to require treatment.

Zonagen is a clinical-stage biopharmaceutical company based in The Woodlands, Texas, that develops drugs to treat hormonal and reproductive system disorders.

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