SAN FRANCISCO and EMERYVILLE, Calif., June 16 /PRNewswire-FirstCall/ -- Bionovo Inc. today announced results from in vitro studies in neurons of its drug candidate, MF101. The data were presented at the Endocrine Society 90th Annual Meeting. Bionovo showed that, in neurons differentiated from mouse stem cells and expressing native estrogen receptors, MF101, an estrogen receptor beta selective modulator, regulated calcium levels, which are related to temperature regulation.
"Menopausal hot flashes occur in approximately 80% of menopausal women," said Dr. Dale Leitman, from the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco. "It has long been known that estrogens reduce hot flashes and non-selective SERMs cause hot flashes. However, there have not been appropriate cell-based models to screen estrogens for effects on neurons. This study demonstrated that changes in calcium levels in neurons, an important biochemical pathway to temperature regulation, are mediated selectively by the activation of estrogen receptor beta. MF101 demonstrated this selective regulation."
The study was conducted by investigators at The Center for Reproductive Sciences in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco in collaboration with scientists at Bionovo.
"Although estrogens are very effective in the treatment of menopausal hot flashes, they have been associated with many serious health risks, such as breast and uterine cancer," said Isaac Cohen, Bionovo's chairman and chief executive officer. "In a Phase 2 clinical trial, MF101, our selective estrogen receptor beta modulator, was effective in the treatment of hot flashes. But unlike estrogen, it did not adversely effect the uterus. This study provides a further mechanistic explanation to the observed clinical results. We believe that the efficacy coupled with improved safety of MF101 over current estrogen treatment will be greatly welcomed by women going through menopause. The results also demonstrate Bionovo's robust science for its pipeline under development for women's health."
About MF101
MF101 is an estrogen receptor beta (ER-b) selective drug for the treatment of menopausal hot flashes, developed as an alternative to those products currently on the market, which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with estrogen receptor alpha (ER-a) activation and that estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. Bionovo recognized the opportunity to commercialize a product that would be equally effective, with an improved safety profile to hormone therapy. 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.
Bionovo, Inc.
Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, which are markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, 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, 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 http://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.
CONTACT: Investors, Lauren Glaser of The Trout Group, +1-415-392-3310,
lglaser@troutgroup.com, For Bionovo Inc.; or Media, Tom Chesterman of
Bionovo, +1-510-420-4189, investor@bionovo.com
Web site: http://www.bionovo.com/
