November 4, 2008
Bionovo to Advance Breast Cancer Drug to Phase II Studies
Bionovo, a clinical stage drug discovery and development company, has announced that its drug candidate for metastatic breast cancer, BZL101, will advance to Phase II clinical testing after the successful completion of a second Phase I clinical trial.
The Phase Ib 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 in this Phase Ib trial.
Results from the Phase Ib show Bionovo's lead drug candidate for advanced breast cancer continues to be safe and well-tolerated, with early signs of clinical efficacy.
The Phase II 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 Charles Shapiro, director of breast oncology at Ohio State University.
Isaac Cohen, president and CEO of Bionovo, said: "We are encouraged by the results of the company's second Phase I trial in women with advanced breast cancer. 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 lower side effect profile."