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Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
Date:12/3/2008

rmalities were observed during the study. The only side effect observed was mild loose stools (12% in treatment group vs. 3% in the placebo group). To date, no significant toxicities have been observed in any of the animal studies with doses ranging from 2000 mg/kg/day in dogs to 16,000 mg/kg/day in rodents.

"The positive results of Menerba to date are very encouraging. Our discussions with the FDA clinical staff, our Scientific Advisory Board, our clinical investigators, and our reception at the many scientific conferences at which we have presented -- all have served to strengthen our confidence that Bionovo's Menerba will be able to provide menopausal women with a safe and efficacious alternative to the existing drugs on the market. This is particularly important because all current drugs for hot flashes carry six black box warnings by the FDA for potentially serious adverse events. As a next step, we have plans to meet with the clinical review team at the FDA to reach an agreement on the clinical path forward," said Dr. Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.

"Menerba provides a true paradigm shift in the treatment of menopausal hot flashes. The novel mechanism of action, the exciting preclinical and clinical safety, and the early efficacy are encouraging. I believe swift development is warranted so we can provide women with an alternative to hormone therapy," said Wulf Utian, M.D., Ph.D., D.Sc. Founder and President Emeritus of the

North American Menopause Society and Menerba's Principal Clinical Investigator.

The Company expects to initiate clinical trials by the second quarter of 2009 subject to FDA review.

About 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
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SOURCE Bionovo, Inc.
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5. Bionovo Elucidates Mechanism of Breast Cancer Control by Estrogen Receptor Beta
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