Actinium Pharmaceuticals’ Iomab-B drug has secured orphan designation from the European Medicines Agency (EMA) in the European Union (EU).

Upon securing approval, Actinium intends to bring Iomab-B  for patients in the EU with relapsed or refractory acute myeloid leukaemia (AML) older than 55 for a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT).

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Iomab-B is a radio-immunoconjugate comprising a novel murine monoclonal antibody BC8 and is currently in a 150 patient multicentre, pivotal Phase III trial being conducted in the US.

Actinium Pharmaceuticals executive chairman Sandesh Seth said: “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 US.

"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."

“We believe Iomab-B represents a potentially revolutionary therapy for relapsed or refractory AML patients who are older than 55 and 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.”

Rare diseases that are defined as life-threatening or chronically debilitating conditions can secure orphan designation from the EMA.

The Fred Hutchinson Cancer Research Centre developed BC8 to target CD45, a pan-leukocytic antigen widely expressed on white blood cells.

When labelled with radioactive isotopes, it will carry radioactivity directly to the site of cancerous growth and bone marrow and avoid effects of radiation on healthy tissues.