On October 4, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported an update on its Actimab-A drug candidate in acute myeloid leukemia (“AML”) (Press release, Actinium Pharmaceuticals, OCT 4, 2017, View Source [SID1234520775]). 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.”
About Actimab-A
Actimab-A, Actinium’s most advanced alpha-particle therapy product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above that are ineligible for standard induction chemotherapy. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer cells. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225 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. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in almost 90 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration.