Actinium Submits Pre-IND Meeting Request to the U.S. FDA for its Iomab-B Drug Candidate
Represents Major Step in Company's Preparations to Commence Upcoming Pivotal Phase 3 Trial in Mid-2015
NEW YORK, NY--(Marketwired - January 26, 2015) - Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today 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).
Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study if it is successful. The trial 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.
Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in such statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Actinium Pharmaceuticals, Inc.
Evan Smith, CFA
VP Investor Relations and Finance