EMERYVILLE, Calif., Sept. 3 Bionovo, Inc. (Nasdaq: BNVI) announced it will be presenting the positive results from the phase 2 clinical trial of their lead drug candidate for postmenopausal symptoms, Menerba, to the international community at the 8th Annual European Society for Gynecology (EGS) in Rome, Italy.
The phase 2 clinical trial was designed to evaluate the safety and efficacy of two doses of Menerba versus placebo. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women reporting moderate to severe hot flashes. Highlights from the trial include:
"The novel mechanism of action, the positive efficacy results and the excellent safety profile, make Menerba an extremely promising drug candidate for postmenopausal women. While 40 million women in the United States suffer from hot flashes and night sweats leading to the second largest indication in Women's Health domestically, the opportunity is significantly increased when we factor in international opportunities. We look forward to introducing Menerba to a wider scientific, clinical and pharmaceutical community, where there is demonstrated interest in finding an alternative to hormone therapy on an international basis," said Dr. Mary Tagliaferri, M.D., President and Chief Medical Officer at Bionovo.
"I am very encouraged by the findings of this clinical trial. The novel mechanism of action and phase 2 efficacy and safety results are encouraging and warrant further investigation. Presuming the phase 3 results confirm the findings in the phase 2 trial, there seems no question that, if approved, Menerba's safety and efficacy profile could make it a first line therapy in an indication that clearly needs alternatives," said Wulf Utian, M.D., Ph.D., D.Sc., founder and President Emeritus of the North American Menopause Society and Menerba's phase 3 Principal Clinical Investigator.
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.
-- After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04). -- There was a clear dose response trend in multiple efficacy analyses. -- Menerba reduced the number of times women were awakened from sleep due to hot flashes (night sweats). The median percent reduction in night sweats in the higher dose of Menerba was 67%, statistically superior to placebo (p=0.05). -- Compliance and study retention was excellent: 98% of participants completed the trial, with 91% of participants taking at least 75% of the assigned study medication. -- The only statistically significant adverse event was "transient loose stools" (12% on Menerba vs. 3% on placebo). -- During the trial, there was no difference in the number of uterine bleeding episodes between the treatment groups and placebo and no cases of endometrial hyperplasia or uterine cancer, further demonstrating Menerba's excellent safety profile. -- After 12 weeks of treatment, participants taking Menerba experienced lower body mass index and weight compared to those on placebo.
SOURCE Bionovo, Inc.