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Bionovo Releases FDA-Approved Clinical Development Plan for Menerba
Date:12/13/2010

l allow us to expedite the initiation of the Phase 3 trial, since we will no longer have to halt enrollment after 60 patients are accrued to the trial to allow the DSMB to review safety data. We will be able to complete the Phase 1 study at the same time the required 13-week animal toxicology studies are being conducted and while the Phase 3 clinical trial material is manufactured and packaged," concluded Dr. Tagliaferri.

We anticipate starting the Phase 1 study in Q1, 2011 and beginning the Phase 3A pivotal trial in Q2, 2011.

"We are excited to move Menerba forward in the path to commercialization. Menerba is an important new treatment approach for millions of women suffering from menopausal hot flashes", said Isaac Cohen, O.M.D., Chairman and CEO of Bionovo. "The discussion with the FDA was also fruitful concerning future potential labeling of Menerba. Bionovo provided additional data to support our claim that Menerba is not an estrogen and not a SERM. The FDA acknowledged that Menerba is a selective estrogen receptor beta agonist. Granted we continue to show no safety concerns after the Phase 3 trials, Menerba will provide a safer alternative to current hormone therapy."

About Menerba

Menerba is an oral botanical drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in traditional Chinese medicine (TCM). B
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SOURCE Bionovo, Inc.
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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
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9. Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
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11. Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
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