This study will enroll approximately 56 evaluable patients. The primary efficacy objective is the response rate (confirmed complete response or confirmed complete response without platelet recovery) achieved over 3 cycles of banoxantrone. The secondary efficacy objectives are duration of response and overall survival. The study will evaluate the safety and tolerability of banoxantrone as a monotherapy for patients with acute lymphoblastic leukemia (ALL), whose disease had either relapsed or was refractory to one or more prior chemotherapy regimens.
John Curd, president and chief medical officer, said: “As part of our expanded development plans for banoxantrone, we believe the product candidate has the potential to help patients with acute lymphoblastic leukemia, a devastating disease with limited treatment options. Banoxantrone is a proprietary anticancer prodrug with a novel mechanism of action. In preclinical models, we have observed that the activated banoxantrone demonstrated potent cytotoxicity against tumor cells derived from hematological malignancies, including those from ALL and other forms of leukemia.”