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Bionovo Announces 2009 Highlights and Year-End Financial Results
Date:3/15/2010

ntial pharmacological uses. In addition, our studies have indicated that these compounds do not promote breast or endometrial cancer in animal models, unlike estrogen therapies. This suggests that these ER beta-selective compounds could lead to safer, more appealing therapies for menopausal disorders.
  • Publication of final study results from our Phase 1B trial of Bezielle for metastatic breast cancer. Bezielle showed an excellent safety and tolerability profile. It also showed promising early efficacy in a difficult-to-treat population, including stable disease and tumor regression.
  • International presentation of final study results from our Phase 2 trial of Menerba for menopausal vasomotor symptom treatment. These results included:
    • 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 g
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    SOURCE Bionovo, Inc.
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    1. Bionovo, Inc. to Announce Fourth Quarter and Fiscal Year 2009 Financial Results on Monday, March 15, 2010
    2. Bionovo Announces Publication of Positive Results From the Phase 1B Clinical Trial of Bezielle (BZL101) for Metastatic Breast Cancer
    3. Bionovo Announces Third Quarter 2009 Highlights and Financial Results
    4. Bionovo, Inc. to Announce Third Quarter Fiscal Year 2009 Financial Results on Thursday, November 5, 2009
    5. Bionovo Announces Publication of Data on Potential Increase in Breast Cancer Risk Due to the Inhibitory Effect of Tamoxifen Treatment on Estrogen Receptor Beta
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    7. Bionovos Estrogen Receptor Beta Selective Drugs Have Unique Gene Expression and Cell Type Specificity
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    9. Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
    10. Bionovo Presents Positive Results from Phase 1B Trial of BZL101 for Metastatic Breast Cancer at the Society for Integrative Oncology
    11. Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
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