Recently, Bionovo, Inc. (BNVI) published results from the early-stage study of Bezielle (BZL101), its candidate for treating metastatic breast cancer. The results indicated that Bezielle was well tolerated and also confirmed the safety of the drug. Furthermore, the study provided clinical evidence of anticancer activity in a heavily pretreated population of women suffering from metastatic breast cancer. The most common side effects of the cancer treatment in the early-stage study were mostly minor and gastrointestinal in nature.
The early-stage study was designed to determine the maximum tolerated dose of the oral, anticancer treatment of Bionovo. The study also aimed at determining the safety and feasibility of the Bionovo candidate. The study enrolled 27 women suffering from late stage breast cancer. They did not respond to an average of six prior therapies since diagnosis and the expected survival pre-trial was 90–120 days. To date, 48 women suffering from advanced breast cancer have undergone Bezielle treatment in two earlier studies.
Bionovo intends to advance the candidate into mid-stage studies, 80 women suffering from metastatic breast cancer are expected to be enrolled in the study, to be conducted at 16 clinical centers in the United States.
Headquartered in Emeryville, California Bionovo is focused on the discovery and development of safe and effective treatments for women’s health and cancer. The markets have great potential and are characterized by significant unmet needs. Currently advanced breast cancer does not have effective therapeutic cures.
Over 200,000 women in the United States are diagnosed with breast cancer annually and the disease is the second leading cause of cancer death in women. Although survival following breast cancer treatment is improving, the disease is responsible for over 40,000 deaths annually in the Unites States alone.
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