Much Anticipated Milestone Sets Stage for Transformation of Company in 2016
NEW YORK, NY--(Marketwired - December 17, 2015) - Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. The Company announced today that the FDA has cleared the Company's IND filing for Iomab-B, and that it will proceed with the pivotal, Phase 3 clinical trial. Actinium anticipates the Phase 3, controlled, randomized, pivotal trial to begin enrolling in the first half of 2016 and assuming that the trial meets its end points, it will form the basis for a Biologics Licensing Application (BLA). Actinium also indicated that it will update investors with further details on the company's pipeline including new programs and product candidates from its APIT (alpha particle immunotherapy) platform at its R&D Day in Q1:2016.
"After a challenging twelve month period, we are pleased to have the Iomab-B IND cleared and to be in a position to proceed with the pivotal, Phase 3 trial. In anticipation of this much awaited milestone, we have strategically expanded our core team in recent months and strengthened the balance sheet to prepare for not only the upcoming Phase 3 trial for Iomab-B but also the expected Phase 2 trial for Actimab-A, our novel CD33 targeting construct. The IND clearance represents the elimination of a major risk factor that had been hampering Actinium's progress and our entire team is energized by the achievement of this milestone. This event is a major catalyst that signals Actinium's transformation in 2016 from an early clinical stage company to a later stage company with two product candidates that have the potential to be major medical advances. We look forward to updating investors and potential partners about all of our programs at our R&D Day in Q1:2016," said Sandesh Seth, M.S., MBA, Executive Chairman of Actinium Pharmaceuticals, Inc.
"The clearance of the IND for Iomab-B is a major milestone for Actinium Pharmaceuticals," said Kaushik Dave, Ph.D., MBA, Chief Executive Officer of Actinium Pharmaceuticals, Inc. "Our team has worked extremely hard this year to prepare our IND filing with significant focus being placed on our Chemistry, Manufacturing and Controls efforts. With the IND now cleared, we are eager to ramp up our clinical development activities related to the pivotal, Phase 3 Iomab-B trial."
Actinium's Chief Medical Officer, Dragan Cicic, M.D., MBA, said, "Acute Myeloid Leukemia is a disease that has not seen an approved therapy in decades. Elderly patients in particular have very few treatment options, especially when they are relapsed and refractory. We are excited to begin our Phase 3 trial for Iomab-B as we believe it represents a paradigm shift in the ability to condition, with better outcomes, elderly relapsed and refractory AML patients for a bone marrow transplant, which is the only potential curative treatment for this difficult to treat patient population. In addition, Iomab-B, longer-term, can potentially become the standard of care for many types of bone marrow transplants given the promising body of clinical evidence that has been amassed to date and being added to via the eight other ongoing physician sponsored clinical trials."
The Company established an agreement with the FDA that the path to a Biologics License Application submission could include a single, pivotal Phase 3 clinical study if it is successful. The population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers, including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.
