Actinium Pharmaceuticals Inc (NYSEMKT:ATNM) Receives Clearance for Phase 3 Trial

Actinium Pharmaceuticals Inc (NYSEMKT:ATNM)

Actinium Pharmaceuticals Inc (NYSEMKT:ATNM) has been cleared by Health Canada to start the Phase 3 SIERRA Study of Iomab-B. The trial will be done at clinical trial sites situated in Canada. Iomab-B is Actinium’s primary product to be used in preparing patients for bone marrow transplant. It is currently considered as the only option for patients with certain types of blood cancer or blood anomalies.

The trial will admit a total of 150 patients and will seek to evaluate Iomab-B after which it will be extended to an HSCT study in patients suffering from acute myeloid leukemia (AML) and who are 55 years and older.

According to statistics from the Canadian Blood and Marrow Transplant Group, Canada has around 15 centers which have the capacity to carry out blood and marrow transplants. Between 2015 and 2016, there were 7,693 cases of allogeneic transplants that were done in the country. Out of these, 2,417 were for AML patients.

Commenting on the new development, Actinium Pharmaceuticals Inc (NYSEMKT:ATNM) Chief Medical Officer, Dr. Mark Berger, said the clearance is a major milestone in the development of Iomab-B as it will open opportunities for the drug to be made available to patients who need it. He added that the company will be opening 15 to 20 clinical sites in which to undertake the SIERRA trial.

Iomab-B mainly targets with CD45, a pan-leukocytic antigen which is common on white blood cells that have BC8, monoclonal antibody. Actinium Pharmaceuticals Inc (NYSEMKT:ATNM) believes that Iomab-B will help by carrying iodine-131 straight to the bone marrow in a targeted manner. This will help in avoiding the radiation side effects.

In the Phase 2 clinical trial Iomab-B produced 100% positive remission results and patients reported transplant engraftment on the 28th day. Iomab-B was discovered at Fred Hutchinson Cancer Research Center. The drug has been tried on around 300 patients in several blood cancer cases including chronic myeloid leukemia (CML), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), multiple myeloma (MM), Non-Hodgkin lymphomas (NHL) and Hodgkin’s disease (HD). The drug has been given Orphan Drug Designation by FDA.

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About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.