Bionovo to Present Positive Results from Phase 2 Trial of Menerba for Vasomotor Symptoms to the International...(body mass index and weight compared to t...),Health

"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

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
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