– Actimab-A has received Orphan Drug Designation in the U.S.
– Orphan Designation in the EU can result in regulatory assistance, reduced fees and 10 years of market exclusivity
NEW YORK, Dec. 13, 2016 (GLOBE NEWSWIRE) — Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today that the Company has submitted an application with the European Medicines Agency (EMA) seeking Orphan Designation for Actimab-A for patients newly diagnosed with acute myeloid leukemia (AML) age 60 and above who are ineligible for currently used induction therapies. Actimab-A is currently in a 53-patient, multicenter open label Phase 2 trial where it is being studied as a monotherapy in these patients who have low peripheral blast (PB) burden. In a previously completed Phase 1 trial, Actimab-A showed a 50% composite response rate at the dose level of 2.0 μCi/kg/fraction, which is the dose level being studied in the current Phase 2 trial, in patients with low PB burden.
“Orphan designation brings significant benefits to the drug development process,” said Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. “We are excited to have submitted this application with the EMA and we are optimistic that Actimab-A will soon have orphan designation in the EU just as it does in the U.S. If this were to occur, both of our clinical product candidates, Iomab-B and Actimab-A, would have orphan designation in the U.S. and EU, which are the largest addressable markets for our product candidates.”