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Bionovo's Independent Data Safety Monitoring Board Recommends Continuation of Phase 3 Study for Menerba™
Date:3/28/2012

smaller Phase 2B trial with the current cohort of 280 randomized participants or to complete the planned Phase 3 study.

The purpose of the study is to evaluate the safety and efficacy of two doses of Menerba™ (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes. (Logo: http://photos.prnewswire.com/prnh/20111110/SF04662LOGO)

Participants are randomized to Menerba™ 5g/day, Menerba™ 10g/day or placebo and treated for 12 weeks. Efficacy will be measured by the reduction of moderate to severe hot flashes from baseline to 12 weeks of treatment Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University is serving as the Principal Investigator for this study.

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
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SOURCE Bionovo, Inc.
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