Profile: Actinium Pharmaceuticals Inc (ATNM.N)
Actinium Pharmaceuticals, Inc. (Actinium), incorporated on March 20, 2013, is a clinical-stage biopharmaceutical company engaged in developing cancer treatments. The Company is engaged in developing therapies for diseases using its alpha particle immunotherapy (APIT) platform and other related technologies. The Company's products include Actimab-A, an antibody-drug construct containing actinium 225 (Ac-225), and Iomab-B, an antibody-drug construct containing iodine 131 (I-131). Actimab-A is in human clinical trials stage for acute myeloid leukemia (AML) and Iomab-B in clinical trial stage for use in myeloconditioning for hematopoietic stem cells transplantation (HSCT) in various indications. Actinium's products under development are monoclonal antibodies labeled with radioisotopes. It has four product candidates in clinical trials: Actimab-A (HuM195-Ac-225), Iomab-B (BC8-I-131), BC8-Y-90 and BC8-SA. The Company is pursuing development of Actimab-A and Iomab-B, while BC8-Y-90 and BC8-SA are in physician sponsored clinical phase I trials at the Fred Hutchinson Cancer Research Center (FHCRC).
Actinium, together with its subsidiary, MedActinium, Inc. (MAI), (collectively known as Actinium) has initiated collaborative efforts with large institutions to establish the alpha particle immunotherapy and has supported one Phase I/II clinical trial and one Phase I clinical trial at Memorial Sloan-Kettering Cancer Center (MSKCC) under an MSKCC Physician Investigational New Drug Application (IND) Application. It is preparing for a Phase III trial of Iomab-B for bone marrow conditioning for HSCT in relapsed and refractory AML patients of age of over 55 and older. Its Ac-225-based drug development relies on the APIT platform technology co-developed with MSKCC. Its activities for Actimab-A include progressing a multi-center Phase I/II trial, support for a Phase I clinical trial at MSKCC, managing isotope and other materials supply chain, and managing the manufacturing of the finished drug candidate product. Its operations related to Iomab-B include planning for a Phase III pivotal trial, which will include development of commercial scale manufacturing to be suitable for an approval trial and preparation of regulatory submissions.
The Company has also developed its own process for industrial scale Ac-225 production in a cyclotron in quantities adequate to support full product commercialization. The Company's APIT technology is based on attaching actinium 225 (Ac-225) or bismuth 213 (Bi-213) alpha emitting radioisotopes to monoclonal antibodies. It has in-licensed a Phase II clinical stage monoclonal antibody, BC8, which is in over seven Phase I and Phase II clinical trials. Actimab-A is in multicenter Phase I/II clinical trial in AML. Actimab-A consists of the monoclonal antibody Lintuzumab and alpha emitting radioisotope actinium 225 (Ac-225). The Company's product candidate, Iomab-B, consists of the monoclonal antibody BC8 and beta emitting radioisotope iodine 131 (I-131). The ongoing clinical trials for Iomab-B include trials for indications, such as relapsed and refractory Hodgkin Lymphoma and Non-Hodgkin's Lymphoma (NHL) in adults; advanced AML, acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS) in adults; AML 1st remission (age 16-50), and High-risk MDS and advanced AML (age 16-50).
The Company competes with Bayer AG, GlaxoSmithKline Plc and Spectrum Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc
275 Madison Ave Fl 7
NEW YORK NY 10016-1101