Actinium Pharma (ATNM) Submits pre-IND Request for Iomab-B to FDA

January 26, 2015 7:04 AM EST

Actinium Pharma (AMEX: ATNM) announced that it has submitted a request for a pre-IND (Investigational New Drug) meeting to the U.S. Food and Drug Administration (FDA) for the company's Iomab-B drug candidate currently undergoing final preparations to start the pivotal Phase 3 trial in mid-2015. The goal of the pre-IND meeting is to finalize preparations for the final stages of its Iomab-B drug candidate development. The initial indication for Iomab-B is conditioning for bone marrow transplant in older relapsed and refractory acute myeloid leukemia (AML) patients, for which there are no FDA approved therapies.

"The pre-IND meeting request marks an important step in Actinium's development program to obtain US FDA approval for Iomab-B." stated Kaushik J. Dave, President and Chief Executive Officer of Actinium Pharmaceuticals, Inc. "We believe that our planned Phase 3 trial will provide patients and physicians an important treatment option given the strength of Iomab-B's Phase 2 clinical trial results. The prior trial enabled previously ineligible patients to receive the procedure, yielded superior outcomes in terms of initial and durable complete responses compared to current treatments using drug combinations that are unapproved for this indication and also provided a potentially curative long term survival in 19% of patients.

"We are highly focused on moving this product into a pivotal Phase 3 trial in mid-2015," said Dr. Dragan Cicic, Chief Medical Officer of Actinium Pharmaceuticals, Inc. "We look forward to the FDA's response and we are preparing ourselves for our final IND submission and commencement of the pivotal Phase 3. Given the dire medical need in this patient population, we remain committed to moving this program forward as quickly as possible."

The upcoming Phase 3 trial is a randomized controlled two armed multicenter trial with the planned enrollment of 150 patients (75 patients per arm). The trial will be conducted in the US with the primary endpoint of durable complete response, which is a complete response lasting at least 6 months. The secondary endpoint is landmark overall survival at 1 year. Of all the hematological drugs approved in the US to date, about 75% have been approved based on the response rate, with the balance having been approved on disease progression and symptoms control related endpoints. Most recently, complete response was the basis for the December 2014 FDA approval of Blincyto (blinatumomab), an infusion therapy for the treatment of certain patients with acute lymphoblastic leukemia (ALL).



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