Actinium Engages Dr. Roland Turck, Former President, Global Specialty Medicine, Bayer Healthcare as Board Advisor
Dr. Turck to Provide Strategic Advice to Actinium to Support Accelerated Development and Commercialization of Iomab-B
NEW YORK, NY -- (Marketwired) -- 02/04/15 -- 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 engaged Dr. Roland Turck, Managing Partner at TurckBio, as a senior advisor to the Board of Directors. Prior to founding TurckBio, Dr. Turck led Bayer Healthcare's Global Specialty Medicine unit, where most relevant to Actinium, he played a leadership role in the commercialization of the alpha-radiopharmaceutical Xofigo® whose successful launch he prepared in close collaboration with Algeta ASA.
Dr. Turck is a Medical Doctor with more than 20 years' pharmaceutical industry experience at Bayer, Berlex and Schering. He brings extensive oncology experience having supported in various roles the development, global launch and commercialization of several leading oncology drugs including Xofigo®, Stivarga®, Nexavar® and Campath. Throughout his career, he gained broad experience in clinical development, regulatory, market access and commercialization of oncology drugs including radiopharmaceuticals such as Xofigo® which was the most commercially successful launch of a radiopharmaceutical product to date. At TurckBio, he has worked as an independent consultant for a number of leading private and public biotechnology and pharmaceutical companies. Dr. Turck will focus his initial efforts on optimizing the commercial potential of Iomab-B.
Dr. Turck commented, "I am delighted to work with Actinium. I believe Iomab-B could shift the paradigm in how AML patients are prepared for bone marrow transplant. I am extremely impressed with the Iomab-B Phase 1/2 clinical data which I believe demonstrates Iomab-B has the potential to become a very important treatment for older relapsed and refractory AML patients most of whom have no option to receive a potentially curative bone marrow transplant. Iomab-B has the potential to prolong overall survival and improve quality of life in patients with advanced disease. I am equally excited about the significant potential of Actinium's Alpha Particle Immunotherapy Platform for which Xofigo®'s success bodes well."
"Dr. Turck's track record of development and commercialization of several major oncology products on a global scale will be invaluable to Actinium as we move Iomab-B into its pivotal Phase 3 trial, and upon FDA approval, to commercialize the drug to meet the significant unmet need for elderly relapsed/refractory AML patients who cannot get a bone marrow transplant today," stated Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals, Inc. "The company will continue to strengthen its capabilities and leadership to support its mission to develop and commercialize lifesaving therapies to treat unmet medical needs in oncology."
About Bone Marrow Transplant:
Bone marrow transplants (BMT) are most commonly used to treat leukemia and lymphoma, conditions incurred when a blood or immune cell, respectively, becomes cancerous and proliferates. Together, these diseases account for some 50,000 to 75,000 new cases annually in the United States. BMT involves first clearing a patient's body of his or her own immune cells and then transplanting bone marrow, the source of all blood- and immune-forming cells, from a tissue-matched donor. The new cells, which are free of cancer, repopulate the patient's bone marrow and eventually give rise to a functioning set of blood and immune cells, providing a lifelong cure. BMT offers the chance of a "curative" outcome (2+ year survival), and therefore can play a central role in the treatment of AML. The impact of BMT on AML continues to increase with AML being the most common and fastest growing indication for allogeneic BMT, comprising 25% to 30% of all BMT recipients. There are currently over 100,000 BMT survivors across all indications and this number is expected to increase to 250,000 by 2020 and 500,000 by 2030, with 25% of them over age 60.
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.
Contact:Actinium Pharmaceuticals, Inc.Evan Smith, CFAVP Investor Relations and Finance(646) firstname.lastname@example.org
Source: Actinium Pharmaceuticals
Released February 4, 2015