Iomab-B for Hematopoetic Stem Cells Transplantation:

Iomab-A (BC8-I-131 construct) has already been successfully used as a myeloconditioning/myeloablative agent in over 250 patients with incurable blood cancers.  In both Phase I and Phase II trials Iomab-B has led to effective cures in patients with no options left.  The only potentially curative treatment option for those patients is bone marrow transplantation (BMT), but vast majority of patients over the age of 50 are either ineligible for myeloablative conditioning due to concomitant conditions or have a high burden and/or very resistant disease that makes reduced dose conditioning futile.  BC8-I-131 has demonstrated ability to successfully prepare such patients for bone marrow transplants when no other treatment was indicated.  API intends to develop Iomab-B through a regulatory approval via a pivotal registration trial in AML refractory/relapsing patients.  That would allow for a relatively quick path to the market and provide a potentially curative treatment to patients who currently have little or no chance of achieving even a temporary remission, let alone a cure.  The targeting part of the Iomab-B construct is a monoclonal antibody that targets CD45, an antigen widely expressed on hematopoetic cells but not other tissues.  Due to this broad expression, Iomab-B has demonstrated utility in other groups of patients and other indications as well, including Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Hodgkin's Disease and Non-Hodgkin Lymphoma.  These are follow-on indications which could be pursued simultaneously or delayed, for cash conservation, and financed from commercial revenues.  The company is already preparing a program for replacing iodine 131 with actinium 225 to create a second generation drug that would enable a significant expansion of use,described below as Actimab-B, Iomab-B was invented by researchers at Fred Hutchinson Cancer Center, API's key collaborator on this program from whom API obtained rights for all the commercial uses.  Fred Hutchinson Cancer Center played a pivotal role in developing the entire field of bone marrow transplantation and the lead Hutchinson researcher, Dr. E. Donnall Thomas received the 1990 Nobel Prize in physiology/medicine for work in this area.