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Bionovo Announces 2011 Highlights and Year-End Financial Results
Date:3/30/2012

g, if consummated, will change.  There can be no assurance as to the availability or terms upon which such financing and capital might be available. If we are not successful in our efforts to raise additional funds by April 15, 2012, we may be required to further delay, reduce the scope of, or eliminate one or more of our development programs or discontinue operations altogether.  

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 involving 50 clinical sites in the U.S. is a randomized, double blind, placebo controlled study planned for 1,200 menopausal women suffering from 50 or more moderate to severe hot flashes per week.  Due to financial constraints, enrollment of the trial has been voluntarily suspended after 280 patients.
  • 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 was 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 potency compared to the highest dose tested in our Phase 2 study. This level of efficacy at 4 weeks is equivalent to or superior to es
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  • SOURCE Bionovo, Inc.
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    Related medicine technology :

    1. Bionovo Announces Positive Developments in On-going Phase 1/2 Cancer Drug Trial
    2. Bionovo Announces Publication of the Paper Detailing the Mechanism of Action of Its Cancer Drug BZL101
    3. Bionovo Discovers New Estrogen Regulatory Elements for Breast Cancer and Osteoporosis Drugs
    4. Bionovos Drug Candidate for Menopausal Symptoms Shows Effect on Neural Pathways Related to Temperature Regulation
    5. Bionovo Elucidates Mechanism of Breast Cancer Control by Estrogen Receptor Beta
    6. Bionovo Reports on Metabolic Studies Related to Its Menopausal Hot Flash Drug Candidate
    7. Bionovos MF101 Shows Statistically Significant Improvement in Sleep Disturbance from Hot Flashes
    8. Bionovos VG101 Shows Greater Efficacy Than Estrogen in the Treatment of Vaginal Dryness
    9. Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
    10. Bionovo Presents Positive Results from Phase 1B Trial of BZL101 for Metastatic Breast Cancer at the Society for Integrative Oncology
    11. Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
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