Bionovo launches phase 2 trial of MF101 for treatment of menopausal symptoms

By Lisa Kerner

Erie, Pa., Feb. 8 - Bionovo Inc. has begun recruiting participants for its phase 2 clinical trial evaluating its lead drug candidate, Menopause Formula 101 (MF101), for the treatment of menopausal symptoms.

Bionovo expects this phase 2 trial to be completed by the second quarter of 2007, according to a company news release. The trial will take place at four leading academic medical centers in the United States.

MF101 is an estrogen receptor beta selective modulator. It does not activate the estrogen receptor alpha implicated in cell proliferation and tumor formation. Bionovo believes that because MF101 exerts effects on only one of the two known estrogen receptors, it will provide ongoing relief from symptomatic vasomotor symptoms such as hot flashes and night sweats while minimizing the risks associated with hormone therapy.

In a phase 1 clinical trial of MF101 conducted at the University of California, San Francisco, the drug was found to be safe, well tolerated and taken with high compliance, the release stated.

If commercialized, Bionovo's target for MF101 is in the multi-billion dollar menopausal market.

"Recent randomized trials have documented that there are important harms associated with use of postmenopausal hormone therapy," Dr. Deborah Grady, director of the University of California, San Francisco Women's Health Clinical Research Center, said in the release.

"Given this, there is a large unmet need for novel therapies that are both safe and effective for treating menopausal symptoms."

Emeryville, Calif.-based Bionovo is a drug development company focusing on the discovery of novel pharmaceutical agents for cancer and women's health.

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