Benzinga | Mar 30, 2021 09:03AM EDT

Rafael Pharmaceuticals Crosses Enrollment Of 150 Patients In Pivotal Phase 3 Trial Of CPI-613 For Relapsed Or Refractory Acute Myeloid Leukemia

Rafael Pharmaceuticals, Inc. ("Rafael" or the "Company"), a leader in the growing field of cancer metabolism-based therapeutics, today announced that it has crossed the enrollment of 150 patients in its Phase 3 clinical trial for patients with relapsed or refractory acute myeloid leukemia (AML) (ARMADA 2000). The multicenter, open-label, randomized pivotal trial is assessing the efficacy and safety of Rafael's lead compound CPI-613(r) (devimistat) in combination with high dose cytarabine and mitoxantrone (CHAM) compared to high dose cytarabine and mitoxantrone (HAM) therapy in older patients. The announcement comes on the heels of the Company's achievement in receiving FDA fast-track designation for CPI-613(r) (devimistat) in the treatment of AML, at the end of 2020.