Actinium announces FDA clearance for Actimab-A/CLAG-M Phase 1 combo trial
Actinium Pharmaceuticals announced that the Medical College of Wisconsin received clearance from the FDA for the previously announced Investigational New Drug, or IND, application for the Phase 1 trial of Actimab-A in combination with CLAG-M for relapsed or refractory Acute Myeloid Leukemia, or AML, patients. This investigator initiated trial will be conducted at the Medical College of Wisconsin and led by principal investigator Dr. Sameem Abedin in collaboration with Dr. Ehab Atallah. This trial will enroll up to 18 patients and will assess safety as well as efficacy, which will be based on response rates, percentage of patients receiving a bone marrow transplant and overall survival. Actimab-A is an antibody radio-conjugate, or ARC, that combines the anti-CD33 antibody lintuzumab with the radioisotope actinium-225. CLAG-M is a salvage chemotherapy regimen consisting of cladribine, cytarabine, filgrastim and mitoxantrone that has become the standard of care at many institutions across the U.S. in AML patients with relapse.