Bionovo Announces Publication of Positive Phase 2 Trial Results for M...( EMERYVILLE Calif. March 2 /- Bion...)

EMERYVILLE, Calif., March 2 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced the online publication of a peer-reviewed article in the journal, Menopause, reporting Menerba(TM) (formerly MF101) is well tolerated, safe and effective for the treatment of vasomotor symptoms (hot flashes and night sweats) associated with menopause.

The Phase 2 clinical trial was designed to evaluate the safety and efficacy of two doses of Menerba versus placebo. The trial was conducted under the direction of Dr. Deborah Grady, an international key opinion leader, from the University of California, San Francisco. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women reporting severe hot flashes, and was conducted at 6 clinical sites in the U.S. Participants were randomized to drug or identical placebo for 12 weeks.

After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04). There was also a very clear dose response trend in multiple efficacy analyses. When compared to placebo, women in the Menerba high dose group were 2.3 times more likely to have at least a 50% reduction in hot flashes after 12 weeks of treatment (OR 2.3, p=0.03).

The study further elucidated that Menerba reduced the number of times women were awakened from sleep due to hot flashes, also known as "night awakenings" or "night sweats." The median percent reduction in night time awakenings from hot flashes for women randomized to the higher dose of Menerba was 67%, and this reduction was statistically superior compared to placebo (p=0.05).

Menerba was extremely well tolerated with 98% of participants completing the trial and 91% taking at least 75% of assigned d
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