There are currently no effective therapeutic cures for advanced breast cancer and treatment is primarily aimed at palliation of symptoms as well as improving overall survival. Approximately 200,000 women are diagnosed with breast cancer each year and breast cancer is the second leading cause of cancer death. Although survival after breast cancer treatment is improving, there are still over 40,000 deaths per year due to the disease. The annual market for drugs targeted at this disease is estimated at $7 billion.
Mechanism of Action
BN107 is an oral drug designed for the treatment of advanced breast cancer with a novel mechanism of action. BN107 has a unique mechanism of action and selective properties which capitalize on the biological and functional differences between cancer cells and normal cells. BN107 exerts its growth inhibition properties on breast cancer cells via the mitochondrial apoptotic machinery. In addition, BN107 induces death only in estrogen receptor negative breast cancer cells. Bionovo believes the target selectivity of BN107 will result in a better tolerability and safety profile than conventional chemotherapy. Oral administration of BN107 is ideal for chronic treatment and will mark this targeted compound as a promising investigational drug for the treatment of metastatic breast cancer.
Bionovo intends to submit an Investigational New Drug (IND) application to the FDA for BN107 to initiate a multi-center, Phase 1/2, open-label, non-randomized, dose escalation trial to assess the safety and preliminary efficacy of BN107 for the treatment of metastatic breast cancer. A total of 20 women with histologically confirmed breast cancer and measurable stage IV disease will be enrolled to the Phase 1/2 trial. The primary outcome measure will be to assess safety, feasibility, optimal dosing and efficacy of BN107 for advanced breast cancer.