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
BN108 is an oral drug designed for the treatment of advanced breast cancer with a novel mechanism of action. BN108 has a unique, targeted mechanism of action which induces cancer cell death by rapid inactivation of both AKT and mTOR pathways. The target selectivity of BN108 may result in a more tolerable and less toxic treatment for breast and other forms of cancer when compared to conventional chemotherapy.
Bionovo intends to submit an Investigational New Drug (IND) application to the FDA for BN108 to initiate a multi-center, Phase 1/2, open-label, non-randomized, dose escalation trial to assess the safety and preliminary efficacy of BN108 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 BN108 for advanced breast cancer.