On December 13, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported 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 (Press release, Actinium Pharmaceuticals, DEC 13, 2016, View Source [SID1234517061]). 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. Schedule your 30 min Free 1stOncology Demo! "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."
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About EU Orphan Designation
The EMA, through its Committee for Orphan Medicinal Products (COMP), examines applications for orphan designation. To qualify for orphan designation, the prevalence of the condition must be less than 5 in 10,000, it must be life threatening or chronically debilitating and there must be no satisfactory method of treating the condition. Sponsors who obtain orphan designation receive numerous incentives including protocol assistance, a reduction or waving of fees and 10 years of market exclusivity should the therapy be approved. The process of filing and receiving the orphan medicines designation can take between eight to fourteen months in most cases. To learn more please visit EMA’s COMP website View Source
About Actimab-A
Actimab-A, Actinium’s most advanced alpha particle immunotherapy (APIT) product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above. 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 calls. 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 age 60 and above.