Bionovo, Inc. Launches Phase 2 Trial Of MF101 For Treatment Of Menopausal Symptoms
EMERYVILLE, Calif., Feb. 8 /PRNewswire-FirstCall/ -- Bionovo Inc. has begun recruiting participants for their Phase 2 clinical trial evaluating their lead drug candidate, Menopause Formula 101 (MF101), for the treatment of menopausal symptoms. The clinical trial is under the directorship of Dr. Deborah 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, Memphis and the University of Alabama, Birmingham.
Dr. Deborah Grady is Professor of Epidemiology and Biostatistics and of Medicine, Vice Chair of the Department of Epidemiology, and Director of the University of California, San Francisco (UCSF) Women's Health Clinical Research Center. Dr. Grady states: "Recent randomized trials have documented that there are important harms associated with use of postmenopausal hormone therapy. Given this, there is a large unmet need for novel therapies that are both safe and effective for treating menopausal symptoms."
Laboratory data shows 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 2002, the Women's Health Initiative (WHI) Estrogen Plus Progestin Trial with over 16,000 women was stopped early because the standard dose of combination hormone therapy increased the risk of breast cancer, stroke, heart attacks, blood clots and dementia.
"Given the huge market for a safe and effective treatment for menopausal symptoms, we are excited to launch our Phase 2 study of our promising selective estrogen receptor modulator drug candidate," said Isaac Cohen, Bionovo's president and chief executive officer. "Our aim is to discover and develop novel drugs that can abate many of the symptoms of menopause that have historically been treated with hormones. This is a critical area for drug development, since the WHI has shown that the risks of hormone therapy outweigh the benefits."
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.
MF101 is an estrogen receptor beta selective modulator. Unlike currently available hormone therapies MF101 does not activate the estrogen receptor alpha that is known to be 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 animal studies, MF101 did not adversely alter reproductive hormones or promote tumor formation in the breast or uterus, suggesting that it will not increase the risk of either breast or uterine cancer. 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.
Bionovo is a drug development company focusing on the discovery of novel pharmaceutical agents for cancer and women's health. The company is working simultaneously on two distinct discovery approaches, one focusing on pro-apoptotic agents for cancer and a second, in the area of selective estrogen receptor modulators (SERMS) to treat severe menopausal symptoms. The company's lead candidate drug, MF101 is in Phase 2 clinical testing and a second drug, BZL101, designed to treat advanced breast cancer is ready to enter Phase 2. 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: www.bionovo.com.
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.Bionovo, Inc.
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