Zonagen poised to initiate three clinical trials by year end; FDA approval needed

By Angela McDaniels

Seattle, Nov. 11 - Zonagen Inc. said it plans to initiate three clinical trials by the end of year including a U.S. phase 3 trial of Androxal for male testosterone deficiency, a U.S. phase 2 trial of Proellex for uterine fibroids and a European phase 2 trial of Proellex for endometriosis.

The Androxal study will include 200 patients at up to 20 clinical sites in the United States and abroad and is being designed to collect additional safety data on Androxal for the treatment of testosterone deficiency in men with secondary hypogonadism.

An initial review of Zonagen's special protocol assessment filing for the study has been completed by the U.S. Food and Drug Administration, the company said.

Additionally, the company held a pre-investigational new drug application meeting with the FDA in May regarding the U.S. Proellex phase 2 trial.

Contracts have been awarded to clinical research organizations to begin the Androxal and Proellex studies as soon as the FDA releases final permission.

The company anticipates releasing initial data from the three trials during the summer of 2006.

Zonagen is a pharmaceutical company based in the Woodlands, Texas, and develops products that address diseases and conditions associated with the treatment of hormonal and reproductive system disorders.

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