23.11.2015 14:19:52
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Actinium Files Orphan Drug Application For Use Of Iomab-B
(RTTNews) - Actinium Pharmaceuticals Inc. (ATNM) announced that it has filed an Application for Orphan Drug Designation with the U.S. Food and Drug Administration for Iomab-B, a radioimmunotherapeutic that conditions refractory and relapsed Acute Myeloid Leukemia (AML) patients for a Hematopoietic Stem Cell Transplant (HSCT), commonly referred to as a Bone Marrow Transplant (BMT).
The Company has recently submitted an Investigational New Drug (IND) application for Iomab-B with the FDA and is preparing for a pivotal, Phase 3 trial.
Actinium's Actimab-A, which is intended to treat newly diagnosed AML patients over the age of 60, received Orphan Drug Designation on December 1, 2014. Results from the Phase 1 portion of Actimab-A's Phase1/2 trial will be presented at the 57th American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida on December 4 - 8, 2015.

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