Bionovo, Inc. (Nasdaq: BNVI) today announced that the Phase 3 pivotal clinical trial evaluating the safety and efficacy of two doses of its Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes has been started.
The Phase 3 Menerba study is currently open for enrollment of 1,200 postmenopausal women between the ages of 40 and 65 years in the 50 clinical U.S. sites.
Mary Tagliaferri , M.D., Bionovo ‘s President and Chief Medical Officer, commented:
“We have had a very busy and productive year preparing for today’s important launch of the late stage clinical trial in the field of women’s health. As predicted from our vast toxicology data and the mechanism of action, we showed that higher doses of Menerba were very safe and demonstrated a level of efficacy similar to hormone therapy. Today we are proceeding with our first pivotal Phase 3 trial of Menerba with great optimism and enthusiasm. We are elated to be one step closer to providing a truly novel agent for the treatment of menopausal hot flashes to the 40 million women in need of this therapy.”
Company expects to have top-line data from this study in approximately 18 months.
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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.