Bionovo, Inc. announced that its drug candidate for metastatic breast cancer, BZL101, will advance to Phase 2 clinical testing after the successful completion of a second Phase 1 clinical trial.

The Phase 1B clinical trial was conducted to identify the maximum tolerated dose of BZL101 and to determine the safety and feasibility of the company’s novel, oral, anticancer treatment. A total of 27 women with metastatic breast cancer were enrolled to this Phase 1B trial. A total of 48 women with advanced breast cancer have been treated with BZL101 in all clinical trials to date. Results from the Phase 1B show Bionovo’s drug candidate for advanced breast cancer continues to be safe and well-tolerated, with early signs of clinical efficacy.

‘We are encouraged by the results of the Company’s second Phase 1 trial in women with advanced breast cancer,’ said Isaac Cohen, President and CEO, Bionovo. ‘There are currently over 160,000 women in the United States living with advanced breast cancer who are eagerly awaiting an oral anticancer drug with minimal side effects and the ability to extend life without profoundly diminishing quality of life. We believe BZL101 may be an important new anticancer agent because its biological selectivity allows the drug to kill cancer cells without affecting normal cells. This will lead to a dramatically lower side effect profile.’

Phase 2 Clinical Trial
The Phase 2 clinical trial is currently enrolling 80 women diagnosed with advanced, measurable breast cancer who have received no more than two prior cytotoxic cancer therapies.

The Principle Investigator of the trial is Dr. Charles Shapiro, Director of Breast Oncology at Ohio State University.

Release Date: November 3, 2008
Source: Bionovo