Actinium Pharmaceuticals wins EMA orphan designation for radioimmunoconjugate Iomab-B.
M2 PHARMA-October 19, 2016-Actinium Pharmaceuticals wins EMA orphan designation for radioimmunoconjugate Iomab-B
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Biopharmaceutical company Actinium Pharmaceuticals (NYSE MKT:ATNM) reported on Tuesday the receipt of the orphan designation in the European Union (EU) from the European Medicines Agency (EMA) for its lead asset, Iomab-B.
Upon EMA approval, Iomab-B is intended to be used 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), according to the company.
Currently, Iomab-B is in a 150 patient multicentre, pivotal Phase 3 trial that is being conducted in the US, added the company.
Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed 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, chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, Hodgkin's disease, Non-Hodgkin lymphomas and multiple myeloma, revealed the company.
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. It is expected to provide increased communication and guidance from regulators and ten year market exclusivity should marketing authorisation be obtained
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|Date:||Oct 19, 2016|
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