NEWARK, NJ and SEATTLE, WA--(Marketwire - July 11, 2012) - Actinium Pharmaceuticals, Inc. ("API", web site, www.actiniumpharmaceuticals.com) 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."
BC8 is a novel murine monoclonal antibody developed by Fred Hutchinson Cancer Research Center 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 leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (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.
About hematopoietic stem cell transplantation (HSCT)
Hematopoietic stem cell transplantation is a $1.3 billion per year market in the U.S. Over the period 2004 - 2007, the most recent available data, it was the hospital procedure with fastest growing number of hospital stays and aggregate cost growth in the U.S., according to the U.S. Government Agency for Healthcare Research and Quality.
In 2010, about 20,000 transplants were performed in the U.S. Approximately 12,000 were autologous and approximately 8,000 were allogeneic. Worldwide, there were about 60,000 transplants overall: about 34,000 autologous and 26,000 allogeneic. The number of patients over the age of 50 has been steadily increasing over the last decade and based on the latest available data grew from 8 percent in 2000 to 21 percent in 2005 and 27 percent in 2007.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. is a Newark, New Jersey based biopharmaceutical company that 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.
More information at www.actiniumpharmaceuticals.com
Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.