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Bionovo's MF101 Shows Positive Safety, Tolerability and Efficacy in,Phase 2 Trial

EMERYVILLE, Calif., June 04, 2007 /PRNewswire-FirstCall/ -- Bionovo, Inc.'s lead drug candidate, MF101, showed positive Phase 2 results for the treatment of hot flashes associated with menopause. Two hundred and seventeen women were enrolled in the company's double-blind, placebo- controlled, randomized Phase 2 trial. Postmenopausal women with 50 or more moderate to severe hot flashes per week were randomized to one of three treatment groups receiving MF101 (5 grams/day), MF101 (10 grams/day), or placebo for twelve weeks. The trial was led by Dr. Deborah Grady at the University of California, San Francisco and was conducted at six medical centers in the United States: University of California, San Francisco, University of Minnesota, Minneapolis, University of Pittsburgh, University of Tennessee, Memphis, University of Alabama, Birmingham and the San Diego Medical Center for Clinical Research.

Bionovo's primary objectives in the Phase 2 clinical trial were to assess the safety, tolerability and the potential efficacy of two doses of MF101 to reduce the frequency and severity of hot flashes. Both doses of MF101 were more effective than placebo at reducing the frequency and severity of hot flashes from the start of the trial until the end of the treatment period 12 weeks later. In a paired t-test, comparing the number of hot flashes per day after 12 weeks of treatment, MF101 5 gm was better than placebo at 12 weeks but did not reach statistical significance (p=0.06). The higher dose was statistically superior to placebo with a p value of 0.05 and both doses combined were superior to placebo with a p value of 0.04. MF101 showed a trend for improvement in severity of hot flashes compared to placebo with the higher dose showing greater improvement (p=0.1) than the lower dose (p=0.12) and with both doses combined superior to placebo (p=0.08). There was a dose response trend suggesting that the higher dose of MF101 was more effective at reducing both frequency and
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