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Bionovo's MF101 Shows Statistically Significant Improvement in Sleep Disturbance from Hot Flashes
Date:9/15/2008

EMERYVILLE, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced that its lead drug candidate, MF101, for menopausal hot flashes, showed improved sleep quality for women in a Phase 2 study completed earlier this year. The Company previously announced that the study showed positive results in the Phase 2 trial for the primary endpoint of reducing the number of hot flashes when compared to placebo. Additional analyses from the Phase 2 trial now show that MF101 reduced the number of times women were woken up 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 MF101 was 67%, and this reduction was statistically superior compared to the placebo (p=0.05). Women randomized to the lower dose of MF101 also had a greater reduction of night time awakenings due to hot flashes compared to placebo (58% reduction versus 44% reduction with placebo).

The trial was conducted under the directorship of Dr. Deborah Grady at the University of California, San Francisco and recruitment took place 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. Two hundred and seventeen women were enrolled in the company's multicenter, 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 one of two doses of MF101 or placebo for twelve
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SOURCE Bionovo, Inc.
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