Actinium Pharmaceuticals, Inc. and Fred Hutchinson Cancer Research Center announced today that they have signed an exclusive worldwide license agreement for BC8, an investigational monoclonal antibody developed to target and eradicate cancerous and other white blood cells in preparation for a hematopoietic stem cell transplantation. BC8, developed by the Hutchinson Center, delivers radioactive isotopes directly to the target cells in order to avoid effects of radiation on most healthy tissues.
Under the terms of the license, Actinium Pharmaceuticals has worldwide rights to develop and commercialize BC8. The Hutchinson Center will receive milestone payments and research support funding. Upon commercialization, the Hutchinson Center will also receive royalties on product sales.
Hematopoietic stem cell transplantation (HSCT) is the fastest growing hospital procedure in the U.S. Between 2004 and 2007, the most recent available data, procedure related hospital stays grew 51.3 percent, according to the U.S. Government Agency for Healthcare Research and Quality.
"Even though most patients with blood cancers are commonly older than 50, currently available preparatory regimens for HSCT, the only potentially curative procedure for many patients, may be intolerable or completely ineffective for those patients. By using BC8 to deliver radiation directly to the diseased bone marrow and lymphatic system we hope to provide the most high-risk patients for the first time with a real possibility of a cure," said John Pagel, M.D., Ph.D., associate member of the Clinical Research Division at the Hutchinson Center and a hematopoietic stem cell transplantation expert.
BC8 can be labeled with a variety of isotopes depending on the type of cancer that necessitated preparation for HSCT. Most advanced in development is BC8 labeled with iodine 131 (I-131), the drug candidate called Iomab™-B. Iomab™-B has already been administered in a number of Phase I and II human clinical trials at the Hutchinson Center in more than 250 patients. Results from these trials evaluating BC8 labeled with radioisotopes have indicated efficacy in a number of blood cancer conditions. In relapsed and refractory acute myeloid leukemia (AML) patients over the age of 50, treatment with Iomab™-B has enabled successful transplants leading to extended survival in approximately one third of the patients. Currently available transplant preparation modalities for such patients are generally considered futile by physicians.
"Actinium Pharmaceuticals intends to progress Iomab™-B development into a multicenter trial as soon as possible," said Dragan Cicic, M.D., President and CEO of Actinium Pharmaceuticals. "We are delighted that this license could provide us an opportunity to advance the Iomab™-B drug candidate into final clinical studies with the goal of making it available to patients in the shortest possible time. We intend to work in parallel on developing an additional drug candidate by labeling the BC8 antibody with actinium 225 isotope using our proprietary Alpha Particle Immunotherapy Technology (APIT) platform, which we expect will allow us to expand the product's market potential."