A Phase 1 trial of Actimab-A in combination with CLAG-M for relapsed or refractory Acute Myeloid Leukemia (AML) patients, will be conducted at the Medical College of Wisconsin and led by principal investigator Dr. Sameem Abedin in collaboration with Dr. Ehab Atallah, as the FDA has cleared the Investigational New Drug (IND) application.
Actinium Pharmaceuticals, whose Actimab-A is lead drug candidate from its CD33 program and is an antibody radio-conjugate (ARC) that is comprised of the CD33 targeting antibody lintuzumab and actinium-225, an alpha-emitting radioisotope, said the trial will enroll up to 18 patients and will assess safety as well as efficacy. It which will be based on response rates, percentage of patients receiving a bone marrow transplant and overall survival., Actinium further said.
Actimab-A is an antibody radio-conjugate (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.
Dr. Mark Berger, Actinium’s Chief Medical Officer said that the use of Actinium’s actinium-225 – anti-CD33 ARC in combination with cytotoxic therapies such as CLAG-M has the potential to improve outcomes for a significant number of patients. He expressed his belief that Actinium’s ARC approach, has the potential to be synergistic with cytotoxic chemotherapy agents. He added that CLAG-M has shown compelling results in patients with relapsed or refractory disease which leads to belief that the combination with the ARC can improve response rates, transplant rates and overall survival for patients. “We are excited to begin enrolling patients on this trial and look forward to working with Dr. Abedin, Dr. Atallah and their colleagues at the Medical College of Wisconsin on this important Phase 1 study,” Berger said.
This Phase 1 combination trial is the fourth clinical trial from Actinium’s CD33 program. Actinium’s other CD33 program trials include its Phase 2 trial Actimab-A trial for patients newly diagnosed with AML who are over the age of 60 and unfit for intense chemotherapy and the Phase 1 Actimab-M trial for patients with refractory multiple myeloma. A Phase 2 trial is planned for patients with high-risk myelodysplastic syndrome with a p53 genetic mutation for myeloablation prior to a bone marrow transplant.
Sandesh Seth, Actinium’s Chairman and CEO said that the use of our ARC’s in combination with chemotherapy could be an exciting development opportunity that has the potential to bring benefits to a significant number patients. He added that this could be the first of many combinations given the potency of Actinium’s ARC approach together with its minimal extramedullary toxicities and its unique mechanism of action. He concluded: “Together these attributes make our ARC a versatile therapy that we believe can bring benefits to patients as a monotherapy, in combination and for myeloablation prior to a bone marrow transplant.”