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Bionovo Initiates Menerba (MF101) Phase 3 Clinical Trial for Menopausal Hot Flashes
Date:10/26/2011

this therapy," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.

"This Phase 3 trial is one of two Phase 3 trials required by the FDA for approval," said Isaac Cohen, O.M.D., Chairman and Chief Executive Officer of Bionovo. "Menerba (MF101) has an enormous proven market and extraordinary market appeal due to its botanical origins and the safety and efficacy it demonstrated to date. We expect to have top-line data from this study in approximately 18 months."

About Menerba

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 a
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SOURCE Bionovo, Inc.
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