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Bionovo Announces Publication of Positive Results From the Phase 1B Clinical Trial of Bezielle (BZL101) for Metastatic Breast Cancer
Date:1/14/2010

EMERYVILLE, Calif., Jan. 14 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) announced today the publication of their results from its phase 1B clinical trial of Bezielle (BZL101) for metastatic breast cancer. The results of the study are available online in Breast Cancer Research and Treatment and demonstrate that Bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer. Preliminary results from this study were released previously by the Company.

The purpose of the phase 1B clinical trial was to identify the maximum tolerated dose of Bezielle and to determine the safety and feasibility of the company's novel, oral, anticancer treatment. A total of 27 women with late stage breast cancer were enrolled to the phase 1B trial. The 27 enrolled women had failed an average of six prior therapies since diagnosis with metastatic breast disease and expected survival pre-trial was 90–120 days. To date, a total of 48 women with advanced breast cancer have been treated with Bezielle in two early phase clinical trials.

Highlights of the Bezielle phase 1B clinical trial are as follows:

  • Independent radiology showed 6 patients had stable disease.
  • Independent radiology showed 3 patients had evidence of tumor regression consistent with a minimal tumor response (>0% and <30%).
  • Three patients had stable disease for >120 days.
  • Four patients discontinued Bezielle with stable disease; one was on Bezielle for 449 days and had evidence of minimal tumor regression and continues to be stable for 700+ days. A second patient remained stable for 836 days a
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SOURCE Bionovo, Inc.
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