Actinium Pharmaceuticals said pre-market it received clearance from Health Canada to begin a phase 3 trial of Iomab-B at Canadian clinical trial sites. The trial consists of a 150-patient study that will evaluate Iomab-B followed by a hematopoietic stem cell transplant (HSCT) in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Iomab-B is intented to prepare and condition patients for HSCT also known as a bone marrow transplant, which is considered the only potential cure for patients with certain blood-borne cancer and blood disorders, the company noted.
Actinium chief medical officer Mark Berger said the company is “expecting to open 15-20 clinical trial sites in the SIERRA trial and we are excited to begin to have participation from sites in Canada. The promise of Iomab-B is that it will enable a bone marrow transplant and long term survival for these patients that have few options for treatment.”