API further expands its Phase I/II clinical trial in acute myeloid leukemia patients
NEW YORK, Sept. 12, 2012 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (API), a biopharmaceutical company that develops innovative targeted payload immunotherapeutics, announced that MD Anderson Cancer Center in Houston, Texas has joined the Company's ongoing Phase I/II trial in newly diagnosed patients with acute myeloid leukemia (AML). The trial is designed to establish safety and efficacy of API's drug Actimab-A in AML patients over the age of 60. Actimab-A treatment consists of the isotope Actinium 225 attached to the anti-CD33 monoclonal antibody lintuzumab (HuM195).
"This is an important milestone in the development of our drug candidate," said Jack Talley, CEO of Actinium Pharmaceuticals. "MD Anderson is a leading cancer treatment institution and treats more patients with acute myeloid leukemia than any other center in the world. We view their joining our trial as a key vote of confidence for our innovative, world class technology."
MD Anderson is the third center to sign a clinical trial agreement with Actinium Pharmaceuticals, following Memorial Sloan Kettering Cancer Center (MSKCC) in New York, NY and Fred Hutchinson Cancer Research Center (FHCRC) in Seattle, Washington.
Phase I/II multi-center Actimab study will build on the previous phase I/II Bismab-A study with a less potent bismuth-213 (Bi-213) isotope and an earlier Actimab-A phase 1 study (where only a single dose of Actimab was administered). The Phase II portion of the earlier Bismab-A study demonstrated the efficacy of API's alpha particle platform by producing a number of complete responses in difficult-to-treat relapsed, secondary and poor cytogenetics AML patients with no standard of care options available. The goal of the current study is to confirm efficacy and safety of Actimab-A using the same antibody targeting mechanism with the actinium isotope, produced by an improved method of manufacture, and to study the effect of multiple doses of treatment. The population for this study will be patients with newly diagnosed AML who are over the age of 60 years, an age in which many chemotherapy regimens are not tolerated. In other published studies in AML, newly diagnosed patients had better responses than relapsed patients.
Actimab-A is a drug candidate construct made using Actinium Pharmaceuticals' proprietary patented technology for arming monoclonal antibodies with alpha emitters actinium 225 and bismuth 213. Antibodies are used as high precision delivery systems that bring powerful alpha emitters into or immediately next to targeted cancer cells. Actimab-A consists of the Lintuzumab monoclonal antibody and actinium 225.
Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. The technology was first developed by Dr. David Scheinberg at Memorial Sloan Kettering Cancer Center.
Lintuzumab is a monoclonal antibody that targets CD33, found on myeloid leukemia cells. It is the humanized version of M195, the antibody initially developed by Dr. David Scheinberg of Memorial Sloan Kettering Cancer Center.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. is a Newark, New Jersey based biopharmaceutical company that develops innovative alpha particle immunotherapeutics based on its proprietary platform for the therapeutic utilization of alpha particle emitting actinium-225 and bismuth-213 radiopharmaceuticals in association with monoclonal antibodies.
For more information:
Visit our web site www.actiniumpharmaceuticals.com or contact:
Jack Talley, CEO
Actinium Pharmaceuticals Inc.
Tel: (646) 459-4201
E-mail: [email protected]
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.
SOURCE Actinium Pharmaceuticals, Inc.