MD Anderson joins API’s Actimab-A Phase I/II trial in acute myeloid leukemia

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.