EMERYVILLE, Calif., Dec. 6 /PRNewswire-FirstCall/ -- Bionovo, Inc.'s paper describing the mechanism of action of MF101, the company's lead drug candidate for menopausal symptoms, has been published in Endocrinology, a journal published by The Endocrine Society. The paper titled "Selective activation of estrogen receptor beta transcriptional pathways by an herbal extract" details how MF101 is selective to the estrogen receptor beta (ER-b) and does not affect estrogen receptor alpha (ER-a). This is a significant milestone toward the development of safe and effective drugs for menopause since it has been shown that the increased risk of breast and uterine cancers is associated with ER-a activation and that ER-b blocks the growth promoting effects on breast cancer cells.
"The results of our studies have demonstrated that MF101's ER-b selective estrogens may be a safer alternative to alleviate symptoms of menopause than traditional estrogens," said Dale Leitman, M.D., Ph.D., Center for Reproductive Endocrinology, University of California, San Francisco and member of Bionovo's Scientific Advisory Board. "Our findings suggest that targeting the ER-b will not only preserve the anti-inflammatory action potentially responsible for combating hot flashes and osteoporosis but will also be devoid of the proliferative effects of estrogens used in hormone therapy that are responsible for causing cancer."
The current study demonstrated that ER-b selectivity by MF101 is not due to differential binding since MF101 binds equally to ER-a and ER-b, but instead, showed that MF101 produces a different conformation in ER-a from ER-b resulting in selective ER-b regulation. The study also demonstrated that MF101 did not activate the genes that mediate the increased risk of breast and uterine cancers caused by estrogens. This effect of MF101 was confirmed in a mouse breast cancer model.
"Today, people are more familiar with the issues associated with menopause than ever before, because the life expectancy of women has risen dramatically over the past several decades. The results of the Women's Health Initiative (WHI) trial have shown that traditional hormone therapy increases the risks for breast cancer, strokes, heart disease, dementia and blood clots and the data have left women with few safe options to alleviate their symptoms," said Mary Tagliaferri, M.D., co-founder and Chief Medical Officer, Bionovo. "The mechanism of action of MF101 suggests that it may provide women with relief from menopausal symptoms, such as hot flashes and night sweats, while not compromising their overall health. Prior to the results of the WHI, the hormone therapy market was approximately $6.5 billion. With the baby boomers now transitioning into menopause, we expect the market size of those women looking for a safe and effective solution to grow dramatically."
MF101 is currently in Phase 2 clinical testing at six clinical sites throughout the country. The Principal Investigator for the Phase 2 trial is Dr. Deborah Grady, University of California, San Francisco. The Company anticipates that results from the Phase 2 trial will be available in the second quarter of 2007.
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 two drugs in clinical testing. MF101 is in Phase 2 for quality of life conditions associated with menopause and BZL101 is in Phase 1/2 for the treatment of advanced breast cancer. The company has an additional pipeline of drugs in development for breast cancer, pancreatic cancer and other menopausal symptoms with a total of 5 drug candidates expected to be in clinical trials by the end of 2007. 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 Medical Center in Dallas, TX. For further information please visit: http://www.bionovo.com .
Forward-Looking Statements
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, 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.CONTACT: Jim Stapleton, Chief Financial Officer, BioNovo, Inc.,+1-510-601-2000, or jim@bionovo.com; or media, Jennifer Larson,+1-415-409-2729, or jlarson@labfive.com; or investors, Antima "Taz"Sadhukhan of Investor Relations Group, +1-212-825-3210
Web site: http://www.bionovo.com/
