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Bionovo to Present Positive Results from Phase 2 Trial of Menerba for Vasomotor Symptoms to the International Community
Date:9/3/2009

EMERYVILLE, Calif., Sept. 3 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) announced it will be presenting the positive results from the phase 2 clinical trial of their lead drug candidate for postmenopausal symptoms, Menerba, to the international community at the 8th Annual European Society for Gynecology (EGS) in Rome, Italy.

The phase 2 clinical trial was designed to evaluate the safety and efficacy of two doses of Menerba versus placebo. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women reporting moderate to severe hot flashes. Highlights from the trial include:

  • 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 a clear dose response trend in multiple efficacy analyses.
  • Menerba reduced the number of times women were awakened from sleep due to hot flashes (night sweats). The median percent reduction in night sweats in the higher dose of Menerba was 67%, statistically superior to placebo (p=0.05).
  • Compliance and study retention was excellent: 98% of participants completed the trial, with 91% of participants taking at least 75% of the assigned study medication.
  • The only statistically significant adverse event was "transient loose stools" (12% on Menerba vs. 3% on placebo).
  • During the trial, there was no difference in the number of uterine bleeding episodes between the treatment groups and placebo and no cases of endometrial hyperplasia or uterine cancer, further demonstrating Menerba's excellent safety profile.
  • After 12 weeks of treatment, participants taking Menerba experienced lower
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SOURCE Bionovo, Inc.
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