Actinium Pharmaceuticals underlines half of patients treated in the pivotal Phase 3 SIERRA testing Iomab-B in Elderly Relapse Refractory Acute Myeloid Leukemia is the only randomized Phase 3 trial that offers BMT or bone marrow transplant as an option for older patients with active, relapsed or refractory AML or acute myeloid leukemia.
Actinium noted BMT is the only potentially curative treatment option for patients with relapsed or refractory AML and there is no standard of care for this indication. Iomab-B is an ARC or Antibody Radiation-Conjugate comprised of the anti-CD45 antibody apamistamab and the radioisotope I-131 or iodine-131. The 19 active SIERRA trial sites in the U.S. and Canada represent many of the leading bone marrow transplant centers by volume.
Dr. Mark Berger, Actinium’s Chief Medical Officer, said: “We are delighted to reach this key milestone in the SIERRA trial. The positive data thus far has lately translated to great enthusiasm from the trial sites for the study, and we believe this milestone will provide additional impetus.“
Berger further noted that Sierra is a first of its kind trial and to reach this point. He said the company’s team has worked diligently to connect all stakeholders within the trial sites, obtain referrals of these patients who would not normally be considered for transplant, satisfy all regulations and establish a supply chain to service many of the leading transplant centers in the U.S. and Canada.
“In addition, we have made several protocol modifications that resulted in a stronger and more efficient trial. With 19 active clinical trial sites, positive preliminary feasibility and safety data and strong investigator enthusiasm, I believe the hardest part of the trial is now behind us,” he said.
Sandesh Seth, Actinium’s Chairman and CEO, said: “I am proud of our team for reaching this key milestone in the SIERRA trial as it represents a major inflection point for Actinium. Iomab-B is our lead asset for targeted conditioning prior to a BMT. Targeted conditioning is an area of opportunity and unmet medical need for which we have assembled a multi-target pipeline of assets for several attractive indications. We believe we can create significant value by focusing on targeted conditioning indications where, due to safety and efficacy issues related to existing regimens, patients either cannot access, or receive sub-optimal results from, potentially lifesaving therapies such as BMT, CAR-T and other adoptive cell therapies.”