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Bionovo Announces Third Quarter 2011 Highlights and Financial Results
Date:11/10/2011

EMERYVILLE, Calif., Nov. 10, 2011 /PRNewswire/ -- Bionovo, Inc. (NASDAQ: BNVI) today announced third quarter highlights and financial results for the three months ended September 30, 2011.

(Logo:  http://photos.prnewswire.com/prnh/20111110/SF04662LOGO)

"We initiated the first pivotal Phase 3 clinical trial and are actively recruiting patients," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "We are now concentrating on the timely execution of the study and we anticipate results in approximately 18 months."

Key Events and Milestones

  • The Company initiated the first of two pivotal Phase 3 studies for its drug Menerba (MF101) for the treatment of menopausal hot flashes. The trial will be conducted at 50 clinical sites in the U.S. The trial is a randomized, double blind, placebo controlled study in 1,200 menopausal women suffering from 50 or more moderate to severe hot flashes per week.
  • The Company successfully completed a 28-day tolerability trial of Menerba in women investigating higher doses. As expected, there were no safety concerns, no reports of serious adverse events, no changes to blood pressure, heart rate or lab values and no cases of abnormal uterine findings on endometrial biopsies.  A dosing strategy has been established for the Phase 3 study.
  • In addition, in this same study, the Company reported an observed robust clinical effect of Menerba to reduce hot flashes after just 4 weeks of treatment. After 4 weeks of treatment with Menerba at 10g/day, the reduction in moderate to severe hot flashes was 69% (with a p value of 0.003). In addition, there was a 68% reduction in the number of nighttime awakenings due to hot flashes (with a p value of 0.001). The Menerba 10g/day dose used in this study has twice the po
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  • SOURCE Bionovo, Inc.
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