Actinium Pharma's (ATNM) Iomab-B Granted EMA Orphan Designation in r/r AML
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Actinium Pharmaceuticals, Inc. (NYSE: ATNM) announced that the Company’s lead asset, Iomab-B, has been granted orphan designation in the European Union (EU) by the European Medicines Agency (EMA). Iomab-B is intended to be used, upon approval, in preparing patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55 for a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT). Iomab-B is currently in a 150 patient multicenter, pivotal Phase 3 trial that is being conducted in the United States.
“We are excited to have been granted orphan designation in the EU for Iomab-B, which comes in addition to the SME status Actinium was granted and orphan designation for Iomab-B in the U.S.,” stated Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. “We believe Iomab-B represents a potentially revolutionary therapy for relapsed or refractory AML patients who are over the age of 55 who could benefit from a bone marrow transplant, which is a drastically underserved patient population. With additional regulatory support for Iomab-B in the EU through orphan designation and SME status we hope to one day bring Iomab-B to the patients of the EU.”
The EMA grants orphan designation to rare diseases that are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU. With an estimated 30 million people living in the EU this equates to approximately 250,000 people or less for each rare disease.
Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.
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