Actinium Pharmaceuticals, Inc., a biopharmaceutical company that develops innovative targeted payload immunotherapeutics based on its radiopharmaceutical expertise and its proprietary APIT platform, and Fred Hutchinson Cancer Research Centre (FHCRC), a world leader in research to prevent, detect and treat cancer and other life-threatening diseases,  have signed an exclusive worldwide license agreement for BC8.

BC8 is an investigational monoclonal antibody developed to target and eradicate cancerous and other white blood cells in preparation for a haematopoietic stem cell transplantation. BC8, developed by the Hutchinson Centre, delivers radioactive isotopes directly to the target cells in order to avoid effects of radiation on most healthy tissues.

Under the terms of the licence, Actinium Pharmaceuticals has worldwide rights to develop and commercialize BC8. The Hutchinson Centre will receive milestone payments and research support funding. Upon commercialization, the Hutchinson Center will also receive royalties on product sales.

Haematopoietic stem cell transplantation (HSCT) is the fastest growing hospital procedure in the US. Between 2004 and 2007, the most recent available data, procedure related hospital stays grew 51.3 per cent, according to the US 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, MD, PhD, associate member of the Clinical Research Division at the Hutchinson Centre and a haematopoietic 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 Centre 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 leukaemia (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 multicentre trial as soon as possible,” said Dragan Cicic, MD, 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.”

BC8 is a novel murine monoclonal antibody developed by Fred Hutchinson Cancer Research Centre to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This broad yet restricted to white blood cells only expression of the antigen makes BC8 potentially useful in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukaemia (CML), acute lymphoblastic leukaemia (ALL), chronic lymphocytic leukaemia (CLL), Hodgkin disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth while avoiding effects of radiation on most healthy tissues.

Hematopoietic stem cell transplantation is a $1.3 billion per year market in the US.

Actinium Pharmaceuticals, Inc. develops innovative targeted payload immunotherapeutics based on its radiopharmaceutical expertise and its proprietary APIT platform for the therapeutic utilization of alpha particle emitting actinium-225 and bismuth-213 isotopes in association with monoclonal antibodies.