EMERYVILLE, Calif., Jan. 6 Bionovo, Inc. (Nasdaq: BNVI) announced today the appointment of European menopause expert, Marco Gambacciani, M.D., to the company's Medical Advisory Board. Dr. Gambacciani is Professor of Obstetrics and Gynecology and Director of the Menopause Research Clinic at the Santa Chiara University Hospital in Pisa, Italy.
"We are honored to have Dr. Gambacciani join our Medical Advisory Board given his well established expertise and publication record in the field of menopause research. We are eager to work closely with Dr. Gambacciani to advance Menerba(TM) through Phase 3 clinical testing in Europe. With Dr. Gambacciani's assistance, we will seek European Medicines Agency (EMEA) regulatory approval for our drug development pathway of Menerba," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.
Dr. Gambacciani stated, "It is very exciting to participate in the late stage clinical development of Menerba for the treatment of menopausal symptoms. Bionovo's novel selective estrogen receptor beta agonist has shown great promise in Phase 2 clinical testing to effectively treat hot flashes and Menerba's safety profile appears superior to currently available hormone therapies. I am eager to launch clinical testing in Europe and believe, if approved, Menerba will be in great demand by women seeking a safe and effective treatment for hot flashes."
Dr. Gambacciani graduated in 1978 from the University of Pisa and finished his residency in Obstetrics and Gynecology in 1982. In 1986 he completed his Postdoctoral Fellowship in Reproductive Endocrinology at the Department of Reproductive Medicine, University of California, San Diego. Since 1987, he has been serving as the Director of the Menopause Research Clinic at the Santa Chiara University Hospital in Pisa.
Dr Gambacciani is also a member of numerous national and international professional societies and he has served as a Member of the Executive Committee of the International Menopause Society. Dr Gambacciani is currently a Member of the Executive Committee of the European Menopause and Andropause Society. He has been a guest faculty member, invited speaker, visiting professor and course director worldwide at many prestigious institutions. He is author of over 120 papers published in peer reviewed international journals. Dr Gambacciani's clinical and research focus includes various aspect of gynecological endocrinology, contraception, biology of menopause and perimenopause, and osteoporosis as well as the risks and benefits associated with the use of estrogen-based therapies.
Menerba is an estrogen receptor (ER) beta selective drug developed as an alternative to postmenopausal hormone products currently on the market, which are both ER beta and ER alpha agonists that 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 ER alpha activation and that ER beta 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 compared to traditional hormone therapy. The clinical trial results have been evaluated by an independent Data and Safety Monitoring Board and the drug candidate has passed through a standard two-phase examination for safety.
Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, 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.
SOURCE Bionovo, Inc.