Actinium Pharmaceuticals Inc (NYSEMKT:ATNM) is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium announced today that it has filed an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for Iomab-B, a radioimmunotherapeutic that conditions refractory and relapsed Acute Myeloid Leukemia (AML) patients for a Hematopoietic Stem Cell Transplant (HSCT), commonly referred to as a Bone Marrow Transplant (BMT). The Company has recently submitted an Investigational New Drug (IND) application for Iomab-B with the FDA and is preparing for a pivotal, Phase 3 trial. Kaushik J. Dave, Ph.D., MBA, CEO of Actinium stated, “We are pleased to have filed an Application for Orphan Drug Designation for Iomab-B. We are confident that Iomab-B meets the criteria for Orphan Drug Designation and are eager to begin the Phase 3, pivotal trial for Iomab-B. Acute Myeloid Leukemia is the most common acute leukemia affecting adults and accounts for the largest number of annual deaths due to leukemia. Refractory and relapsed AML patients, particularly elderly patients, have very few, if any, treatment options other than a Bone Marrow Transplant. Unfortunately, many of these patients cannot tolerate the intensive chemotherapy given prior to BMT. We believe that Iomab-B will allow a greater number of AML patients to receive a BMT and could be a paradigm shift in the way AML patients are treated.” Actinium’s Actimab-A, which is intended to treat newly diagnosed AML patients over the age of 60, received Orphan Drug Designation on December 1, 2014. Results from the Phase 1 portion of Actimab-A’s Phase1/2 trial will be presented at the 57th American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida on December 4 – 8, 2015. Actimab-A data, including patients from the fourth and final cohort, will be presented in a poster session on December 7, 2015 at 6 pm EST. (Original Source)
Shares of Actinium Pharmaceuticals closed last Friday at $2.15. ATNM has a 1-year high of $6.65 and a 1-year low of $1.52. The stock’s 50-day moving average is $2.20 and its 200-day moving average is $2.38.
Actinium Pharmaceuticals Inc is a biopharmaceutical company which develops drugs for treatment of cancer. It is a development stage company.