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Here's what I learned from reading about this drug.
Iomab-B, used in the preconditioning for a stem cell transplant, is a combination of BC8 (a monoclonal antibody developed at the Fred Hutchinson Cancer Research Center) and iodine 131. It targets the CD45 white cell antigen.
The Iomab-B Phase 1 and Phase 2 trial results looked very promising, with 100% of the leukemia and MDS patients in remission 6 months after transplant.
The drug is not specific to MDS, and a lot of the data about it relates to leukemia, but the mechanism is the same in either case. Actinium Pharmaceuticals wants the drug to be approved for MDS, not just leukemia.
They plan a multi-center Phase 3 trial but I'm unclear what the recruiting criteria will be, particularly which bone marrow failure diseases will be included. They are looking for a relatively quick path to FDA approval, but I don't yet see the trial listed at clinicaltrials.gov.
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