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Actinium approaches Phase 3 trial for Iomab-B
September 2015
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NEW YORK—Actinium Pharmaceuticals Inc. has submitted a request for a pre-IND meeting with the U.S. Food and Drug Administration for its Iomab-B drug candidate, which is currently gearing up for a pivotal Phase 3 trial. Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. Fred Hutchinson Cancer Research Center has developed BC8 to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. When labeled with radioactive isotopes, BC8 carries radioactivity to the site of cancerous growths and bone marrow. Iomab-B will be used to prepare patients for hematopoietic stem cell transplantation in a two-arm, randomized, controlled Phase 3 trial of patients with relapsed, refractory acute myeloid leukemia over the age of 55. The primary endpoint will be durable complete remission, defined as a complete remission lasting at least six months, with overall survival at one year as the secondary endpoint.

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