Bionovo, Inc. has initiated its multi-centre phase 1/2 clinical trial of BZL101, its drug candidate for the treatment of women with advanced breast cancer. The aims of the current phase 1/2 trial are to determine the maximum tolerated dose of BZL101 and tumour response in women with late stage breast cancer.
The trial will enrol 80 volunteers who have advanced, measurable breast cancer and have had no more than two prior third line cytotoxic treatments. The study is being coordinated by Dr. Deborah Grady at the University of California, San Francisco (UCSF) and led by Dr. Charles Shapiro, Director of Breast Oncology, Ohio State University. The trial will be open at 10 sites across the country, including The University of Texas M. D. Anderson Cancer Center, University of Texas Southwestern Medical Center, University of Chicago, Duke University, Ohio State University Comprehensive Cancer Center, Memorial Cancer Institute, Montefiore Medical Center, Breastlink/Barbara K. Robinson Breast Cancer Research Program (LBMMC), several comprehensive cancer centres in the Aptium Oncology Research Network, and Cancer Research Network, Inc.
BZL101 is an oral drug designed to induce cancer cell apoptosis, or cell death, while leaving normal cells unaffected. Results from the Company's initial FDA-approved Phase 1 clinical trial showed BZL101 was safe in a cohort of women with advanced breast cancer.
"We are excited to bring our second Bionovo drug candidate into Phase 2 clinical testing to further advance our pipeline and to find safer, less toxic therapeutic treatment options for women with advanced breast cancer," stated Isaac Cohen, CEO and president of Bionovo. "We are working closely with the 10 centres around the country and feel confident that we have the capabilities and expertise to bring to the market a safe, novel compound for the treatment of advanced breast cancer."
Over 200,000 women are diagnosed with breast cancer each year and despite the treatment options available, breast cancer is still the second leading cause of cancer death.
Bionovo is a drug development company focusing on the discovery of novel pharmaceutical agents for cancer and women's health. The company has two drugs in clinical testing. MF101 is in Phase 2 for quality of life conditions associated with menopause, and BZL101 is in Phase 1/2 for the treatment of advanced breast cancer.