Bionovo Completes Enrollment Of MF101 Phase 2 Trial To Evaluate A Safer, New Therapy For Menopausal Symptoms

Main Category: Menopause
Also Included In: Women's Health / Gynecology;  Clinical Trials / Drug Trials
Article Date: 19 Oct 2006 - 0:00 PDT

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Bionovo, Inc. (OTC Bulletin Board: BNVI) provided an update on its Phase 2 clinical trial of MF101, a novel, oral treatment for hot flashes and other symptoms of menopause. The Company has fully enrolled its FDA-approved trial with 184 women volunteers. Dr. Deborah Grady at the University of California, San Francisco is serving as the Principal Investigator and the multi-center trial is being conducted at six clinical sites across the country. The trial will evaluate the efficacy of MF101 on actual and perceived relief from menopausal symptoms. The women enrolled in the trial are aged 40-60 and experiencing greater than 7 moderate-to-severe hot flashes each day.

MF101 is an estrogen receptor beta (ER-beta) selective drug developed as an alternative to those products currently on the market that have been shown to increase the risk for breast and uterine cancers. Bionovo recognized the opportunity to commercialize a product that would be equally effective, with an improved safety profile to hormone therapy, and began the clinical development of MF101. The drug candidate has been evaluated by an independent Data and Safety Monitoring Board and has passed through a standard two-round examination for safety. The Phase 2 study is expected to run for an additional four months with results anticipated in early April 2007.

"For too long women had to face the choice between quality of life and their long-term health," said Isaac Cohen, President and CEO, Bionovo. "The market for menopausal products is enormous and growing, and we believe there is great opportunity for a product that offers both efficacy and safety."

The Phase 2 trial is a double-blind, randomized, placebo-controlled trial. Women volunteers were randomized to groups of 60 receiving 2 doses of MF101 or placebo. The trial is being conducted at the following sites: University of California, San Francisco, University of Pittsburgh, University of Minnesota, University of Tennessee, University of Alabama and the San Diego Medical Center for Clinical Research.

About MF101

MF101, an ER-beta selective agonist, is designed for the treatment of vasomotor symptoms such as hot flashes and night sweats in postmenopausal women. In animal studies, MF101 has been shown to prevent tumor formation in the breast and uterus, suggesting that Bionovo's lead drug will not increase the risk of either breast or uterine cancer. In Phase 1 clinical testing of MF101, the drug was found to be safe, well tolerated and taken with high compliance. A multi-center, Phase 2, double-blind, placebo-controlled, randomized clinical trial of MF101 has completed full enrollment of 180 patients.

About Bionovo, Inc.

Bionovo is a drug development company focusing on the discovery of novel pharmaceutical agents for cancer and women's health. The company has one drug in Phase 2 clinical testing to treat conditions associated with menopause and a second drug, BZL101, for breast cancer that will enter Phase 2 clinical testing later this year. The company is developing its products in close collaboration with leading U.S. academic research centers, including the University of California, San Francisco, University of Colorado Health Sciences Center, University of California, Berkeley, and the University of Texas, Southwestern. For further information please visit: http://www.bionovo.com/.

Bionovo, Inc
http://www.bionovo.com/

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