Clinical trial of new Bionovo menopause drug moves forward

Today, millions of women suffer from often-harsh symptoms of menopause such as hot flashes and night sweats -- and relief is nowhere to be found.

Now a pharmaceutical company called Bionovo Inc. has completed medical studies that show that selective estrogen receptor modulators found in their lead drug, Menopause Formula 101 (MF101) may safely address those debilitating symptoms of menopause.

Now in a Phase 2 clinical trial of MF101, Bionovo has begun recruiting participants to evaluate them for the treatment of menopausal symptoms. MF101 is a selective estrogen receptor modulator that is unlike any currently available hormone therapies.

This second clinical trial of MF101 followed the initial trial conducted at the University of California, San Francisco under the auspices of renowned researcher Dr. Deborah Grady. Laboratory data obtained in that study demonstrated that MF101 does not stimulate estrogen dependent tumor formation or uterine proliferation, and therefore may prove to be a safer alternative to the currently available hormone therapies.

In the initial clinical trial, MF101 provided ongoing relief from symptomatic vasomotor symptoms of menopause such as hot flashes and night sweats, while minimizing the risks associated with hormone therapy by exerted effects on only one of the two known estrogen receptors in the brain, the estrogen receptor beta.

In 2002, the Women's Health Initiative (WHI) Estrogen Plus Progestin Trial, with over 16,000 women participants, was stopped early when it was found that the standard dose of combination hormone therapy increased the risk of breast cancer, stroke, heart attacks, blood clots and dementia.

"Given the void that exists for a safe and effective treatment for menopausal symptoms, our aim is to discover and develop novel drugs such as MF101 that can abate many of those symptoms that have historically been treated with hormones," said Bionovo's chief medical officer, Dr. Mary Tagliaferri. Dr. Tagliaferri is also the co-author of The New Menopause Book: The Experts Help You Make Informed Decisions on HRT, Natural Hormone Therapy, Herbal Therapies, Traditional Chinese Medicine and more (Penguin Group, 2006).

The clinical trials will again be under the directorship of Dr. Grady, and will take place at four leading academic medical centers, including the University of California, San Francisco; the University of Minnesota, Minneapolis; the University of Tennessee Health Science Center, and the University of Alabama, Birmingham.Bionovo expects this Phase 2 trial to be completed by the second quarter of 2007. If commercialized, Bionovo's target for MF101 is in the multi-billion dollar menopausal market.

"This is a critical area for drug development, since the WHI has shown that the risks of hormone therapy outweigh the benefits. If this new drug proves to be effective, we will be providing health care practitioners with a treatment they can freely recommend to women experiencing menopause," said Dr. Tagliaferri.

http://www.bionovo.com/