February 7, 2017: Actinium Pharmaceuticals announced today that a Phase 1 clinical trial studying Actimab-M in multiple myeloma has been initiated. Actimab-M is comprised of the CD-33 targeting monoclonal antibody HuM-195 coupled to the alpha-particle emitter actinium 225. CD33 is an antigen found on hematopoietic cells in certain blood cancers. It is commonly associated with myeloid malignancies including AML, but recent research has shown that CD33 can also be found on malignant cells of approximately 25%-35% of all multiple myeloma patients. Furthermore, the expression of this marker increases in relapsed and refractory myeloma. In addition, it predicts for a very aggressive course of disease. This makes CD33 a potential target for the treatment of this usually fatal disease. Although treatable, multiple myeloma is currently not considered curable and almost all patients eventually relapse or become refractory to available treatments as their condition progresses. In this new trial, Actimab-M will be used in patients who have progressing disease after 3 prior multiple myeloma treatment regimens or are refractory to QUAD (Caflizomib, Lenalidomide, Pomalidomide, Dexamethason).
January 7, 2017: Biotechnology firm Actinium Pharmaceuticals’ stock is basing after coming off a double bottom. I can’t imagine the European Medicines Agency not granting Orphan Designation for Actimab-A. On December 13, 2016, Actinium Pharmaceuticals 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 Ci/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.
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Actinium Pharmaceuticals, Inc., a biopharmaceutical company, develops targeted payload immunotherapeutics for the treatment of advanced cancers. The Company’s radioimmunotherapy product candidates are based on the combination of the cancer targeting precision of monoclonal antibodies (mAb) that seek out specific types of cells combined with the cytotoxic killing power of radioisotopes that unleash their energy once they have reached their target.