Bionovo's MF101 Shows Statistically Significant Improvement in Sleep Disturbance from H... (weeks. Bionovo's primary objectives i...)

Bionovo's MF101 Shows Statistically Significant Improvement in Sleep Disturbance from Hot Flashes

Date:9/15/2008

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Bionovo's primary objectives in the Phase 2 clinical trial were to assess the safety, tolerability and 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.

There was a clear dose response demonstrating that the higher dose of MF101 was more effective at reducing night time awakenings from hot flashes compared to the lower dose and the lower dose was more effective than placebo. These data are also consistent with the dose response trend previously reported where the higher dose of MF101 was more effective at reducing both the frequency and severity of hot flashes than the lower dose and both doses were more effective than placebo.

"These additional positive findings showing that MF101 can improve sleep quality in menopausal women are extremely exciting to the 40 million women who suffer from hot flashes and night sweats," said Mary Tagliaferri, M.D., President and Chief Medical Officer of Bionovo. "As we gear up to start recruitment for our Phase 3 clinical trial of MF101 for the treatment of menopausal hot flashes, these additional beneficial results will help with the swift recruitment of 640 postmenopausal women in this pivotal trial."

"Proving that MF101 significantly helps with menopausal sleep related symptoms further illustrates the potential of our lead drug," said Isaac Cohen, Chairman and CEO of Bionovo. "So far, MF101 has shown efficacy for the treatment of hot flashes and night sweats and our drug has an unmatched safety profile when compared to its competition. With the Phase 3 pivotal trial shortly underway, Bionovo is positioned to be a major player in the second largest indication in Women's Health after contraception, a multibillion dollar opportunity, with no competition with an equivalent offerin
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