Actinium Provides Update On Actimab-A Phase II Clinical Trial For Patients With Acute Myeloid Leukemia

Published: Oct 04, 2017

- Phase 2 clinical trial is currently active at 16 clinical trial sites in the United States, surpassing the 10 clinical trial sites that were planned for the trial

- Actinium affirms guidance for interim analysis by year-end 2017 and top line data in the first half of 2018

NEW YORK, Oct. 04, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, provided an update on its Actimab-A drug candidate in acute myeloid leukemia (“AML”). The Phase 2 trial is currently enrolling patients with AML age 60 and older who are unfit for standard induction chemotherapy. The Phase 2 clinical trial is now active at 16 clinical trials sites and Actinium has reiterated its previously announced guidance for the trial including a planned interim analysis by the end of 2017 and top line data in the first half of 2018. AML is one of the most common forms of leukemia. Approximately 21,000 patients are diagnosed with AML each year with the median ago of diagnosis being 68 years of age. Patients with AML over the age 60 who are ineligible for standard induction chemotherapy have limited treatment options and have a poor prognosis. Actinium’s Actimab-A targets CD33, a marker expressed in approximately 80-90 percent of patients with AML, via a monoclonal antibody that has been linked to actinium-225 (“Ac-225”), an alpha emitting radioisotope.

Dr. Mark Berger, Actinium’s Chief Medical Officer said, “We at Actinium have great confidence in our alpha-particle technology based drug candidate, Actimab-A, and in its ability to benefit patients. This Phase 2 trial in patients age 60 and older will evaluate the ability of Actimab-A to achieve remissions in these poor prognosis patients. The opening of additional sites will help us achieve our goal of an interim analysis by the end of 2017 and topline data in the first half of 2018. The results from the interim readout at year-end are expected to provide valuable insights into the best ways to use Actimab-A and how to differentiate it from other agents. We expect these insights to inform our development strategy going forward.”

Actinium’s Actimab-A phase 2 trial is currently open for recruitment at the following centers:

Center Location
UCLA Medical Center Los Angeles, California
University of Kentucky Lexington, Kentucky
University of Louisville Louisville, Kentucky
Ochsner Medical Center New Orleans, Louisiana
Weill Medical College of Cornell University New York, New York
Columbia University Medical New York, New York
Memorial Sloan Kettering Cancer Center New York, New York
Duke Cancer Center Durham, North Carolina
University of Pennsylvania Philadelphia, Pennsylvania
St. Francis Cancer Center Greenville, South Carolina
Baylor Scott and White Research Institute Dallas, Texas
Swedish Cancer Institute Seattle, Washington
Fred Hutchinson Cancer Research Center Seattle, Washington
West Virginia University Morgantown, West Virginia
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin
VA Caribbean Healthcare System San Juan, Puerto Rico

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, “CD33 is a validated target in AML and in our experience a resurgent area of interest amongst the medical community post the recent reapproval of Mylotarg. Importantly, the CD33 space that continues to garner much interest as evidenced by recent drug approvals, strategic transactions and a robust development pipeline represented by several major pharmaceutical and biotechnology companies. We believe that Actimab-A has the potential to be best in the CD33 class given the combination of its potency as a single agent, its relatively simple administration via two injections, and its relative benign safety profile. We look forward to updating by year-end on the significant progress we are making with the Actimab-A trial.”

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