Actinium Pharmaceuticals Inc. Submits Proposal To FDA For Phase 3 Blood Cancer Trial

Actinium Pharmaceuticals Inc. (ATNM) has announced today that it has submitted a proposal to the FDA for an IND to begin a phase 3 trial to treat patients with Acute Myeloid Leukemia -- AML. The company will use its drug candidate lomab-B in refractory and relapsed AML patients who are over the age of 55 years. The trial will enroll approximately 150 patients in total to evaluate lomab-B efficacy in this patient population. 

The primary endpoint of this phase 3 trial will track complete remission of all the patients taking lomab-B. Complete remission will be characterized as being cancer free for at least 6 months. The secondary endpoint will track overall-survival in one year time point. The goal is to give hope, to observe efficacy in this pivotal phase 3 trial and to establish standard of care for this patient population. 

There are no FDA approved treatments for this patient population with AML, and no current standard of care established to give these patients any hope. Lomab-B may be the drug candidate that these patients need. Lomab-B is a monoclonal anti-body combined with a radioisotope established as an immunotherapeutic to combat against advanced forms of cancer.