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.
"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.
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