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Bionovo, Inc.'s (OTC Bulletin Board: BNVI) paper describing the anti-tumor effects of its lead drug candidate for breast cancer, BZL101, has been published in the journal Breast Cancer Research and Treatment. The manuscript entitled: "Phase 1 Trial and Anti-tumor Effects of BZL101 for Patients with Advanced Breast Cancer" has been highlighted and tagged as a "critical trial". "Due to the strength of our pre-clinical data in breast cancer models, we chose to conduct this study in women with advanced breast cancer rather than a cohort of patients with many different types of tumors," said Dr. Debu Tripathy, MD, Director of the Komen/UT Southwestern Breast Cancer Research Center at the University of Texas Southwestern Medical Center, and Principal Investigator on the trial. "Data from the trial showed that BZL101 demonstrated encouraging clinical activity in this heavily pre-treated population." The paper details the results of the Phase 1 clinical trial and describes the mechanism of action of BZL101. The data presented in the journal article shows that BZL101 works by selectively killing cancer cells while leaving normal cells unaffected. Specifically, BZL101 deprives the cancer cell from producing energy that it needs to survive, thereby prompting apoptosis. Apoptosis is a process of self initiated suicide inherent in all cells but profoundly damaged in cancer cells such that they continue to multiply. In the study, BZL101 has demonstrated the potential for anti-tumor activity in a cohort of women with late-stage breast cancer. "We are encouraged by the results of BZL101's Phase 1 trial in women with advanced breast cancer," said Isaac Cohen, President and CEO, Bionovo. "BZL101 capitalizes on an important biological difference between cancer cells and normal cells which leads us to believe that BZL101 will be an improvement over non-selective breast cancer therapies." The trial involved 21 women with stage 4 advanced breast cancer, who were heavily pre-treated for their metastatic disease. While on the trial, none of the patients suffered any BZL101 related grade III or IV adverse events according to the National Cancer Institute Common Toxicity Criteria for Adverse Events. Early efficacy data from the Phase 1 trial showed a potential survival benefit and evidence of tumor shrinkage. Bionovo plans to initiate a Phase 2 trial of BZL101 in women with advanced breast cancer during the first quarter of 2007. Dr. Tripathy, who will serve as the Principal Investigator for the Phase 2 study, has an extensive background in pre-clinical and clinical trials and was one of the lead investigators on the pivotal Herceptin trials sponsored by Genentech.
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