EMERYVILLE, Calif., June 2, 2011 /PRNewswire/ -- Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced it will be presenting data from the Phase 2 clinical trial of their lead drug candidate for postmenopausal symptoms, Menerba™ (also known as MF101), to the international community at the 13th Annual World Congress on Menopause in Rome, Italy on June 11, 2011.
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. Further analysis of the data was performed to evaluate if the clinical efficacy of Menerba correlates with the willingness of postmenopausal women to use Menerba for the treatment of hot flashes. We found that 73% of women with >/= 50% reduction in hot flashes and 77% of women with >/= 60% reduction in hot flash frequency were willing to continue treatment after 12 weeks of therapy. In our responder analysis, women randomized to Menerba 10 grams/day were 2.3 and 2.4 fold more likely to have >/= 50% or >/= 60% reduction in all hot flashes at 12 weeks of treatment compared to placebo (OR 2.3, p=0.03 or OR 2.4, p=0.02) respectively.
"I am very encouraged by our findings, which show that postmenopausal women are willing to take a safe, non-hormonal agent, such as Menerba, if the frequency of hot flashes is reduced by 50-60%. We know that Menerba has a demonstrated level of efficacy similar to low dose estrogen preparations and is in the target range for approval by the FDA," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "We are eager to initiate our Phase 3 clinical trial in the fall. We have completed enrollment to our ongoing tolerability trial, exploring the tolerability and safety of higher doses, and to date, there have been no reports of serious adverse events, no changes to blood pressure, heart rate or lab values and no cases of abnormal uterine bleeding. The brisk pace of enrollment reflects the strong interest in a novel drug that will be in great demand by the 40 million women transitioning through menopause."
"These are exciting times for Bionovo as we are on target to meet our stated timelines for the year. We completed the construction of our manufacturing facility and have commenced GMP manufacturing of Menerba for the Phase 3 clinical trials. Our ongoing animal toxicity studies continue to show Menerba is extremely safe. We have recruited 40 of the 50 clinical sites for the Phase 3 trial and the research community eagerly anticipates seeing the first novel product in 60 years for this indication start late stage clinical testing in the next few months," stated Dr. Isaac Cohen, Chairman and Chief Executive Officer of Bionovo, Inc.
Menerba is an oral drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause, which is manufactured from botanical sources. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the 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 activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in traditional Chinese medicine (TCM). Bionovo recognizes the opportunity to commercialize a product that would be as effective as hormone therapy, without the health risks. Menerba has completed a Phase 2 trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety. Menerba also has been shown in animal studies to prevent the proliferation of breast cancer and to have a beneficial effect on osteoporosis, though this has not yet been studied in humans.
About Bionovo, Inc.
Bionovo, Inc. 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.|
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