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TMCNet:  Preeminent Oncolocy Clinicians from Leading Cancer Centers Join Actinum's Newly Established Iomab-B Scientific Advisory Board

[June 26, 2014]

Preeminent Oncolocy Clinicians from Leading Cancer Centers Join Actinum's Newly Established Iomab-B Scientific Advisory Board

NEW YORK --(Business Wire)--

Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced the establishment of its Scientific Advisory Board (SAB) for Iomab™-B comprised of several preeminent clinicians in the fields of oncology, hematology, and bone marrow transplant. Combining the wealth of clinical, strategic, and scientific experience in cancer drug development, the Scientific Advisory Board is well suited to support the company's development strategy for the advancement of Iomab™-B, the Company's lead radioimmunotherapy asset, in a Phase 3 trial to potentially address the significant unmet medical need for older patients with acute myeloid leukemia (AML) and well as in other cancer indications.

Kaushik J. Dave, Ph.D., Actinium's President and CEO commented, "We are delighted to welcome this prestigious group of clinicians to our Scientific Advisory Board to support the development and advancement of Iomab™-B in our current late-stage program and in additional cancer indications to address the substantial unmet medical needs of oncology patients. We very much appreciate their enthusiasm to collaborate with us as members of our SAB, which we view as further recognition of our growing presence in the oncology market."

Kaushik J. Dave, Ph.D., concluded, "We are confident that the knowledge and experience of our newly formed SAB, which includes well-recognized world experts in the field of oncology, hematology, and bone marrow transplant, will prove invaluable as we continue our development efforts for Iomab™-B, undertake additional focused development programs, and further enhance our infrastructure to move these programs forward."

The Company's SAB members will guide the continuing clinical development of Iomab™-B, as Principal Investigators, Advisors and Clinicians. The upcoming Iomab™-B Pivotal Clinical Trial has been planned (with direct FDA input) to be a randomized, controlled, multi-center, 150-patient trial evaluating the impact of Iomab-B's impact on AML as determined by a primary endpoint of durable complete remission at 6 months.

Hematologists who have thus far joined the Iomab-B SAB represent major tertiary care cancer treatment centers across the United States, in which a significant percentage of bone marrow transplants (BMT) occur. Treatment with Iomab-B may allow for subsequent curative BMT in patients who would otherwise not qualify for or be able to tolerate the requisite conditioning regiments.

The inaugural members of Actinium's SAB for Iomab™-B include the following renowned clinicians in hematology, oncology and bone marrow transplant. Listed in alphabetical order, the members are:

  • Sergio A. Giralt, MD
    Memorial Sloan Kettering Cancer Center, New York, NY

Dr. Giralt is Chief, Adult Bone Marrow Transplant Service; Acting Chief, Myeloma Service, and a board-certified hematologist/oncologist whose clinical practice and research focus on stem cell transplantation for patients with blood disorders. Dr. Giralt and his colleagues pioneered the use of reduced-intensity conditioning regimens for older or more debilitated patients with blood cancers, and are currently using and studying T cell depletion techniques to dramatically reduce the risk of graft-versus-host disease, a serious complication of donor stem cell transplantation.

Most recently, Dr. Giralt was Deputy Chair of the Department of Stem Cell Transplantation and Cellular Therapies at the University of Texas MD Anderson Cancer Center. He is also the past chair of the steering committee of the Blood and Marrow Transplant Clinical Trials Network, a federally funded group that defines the research agenda for stem cell transplantation in the United States

  • Hillard M. Lazarus, MD
    University Hospitals Case Medical Cente, Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH


Dr. Lazarus is a Professor of Medicine, Director of Novel Cell Therapy, Disease Team Leader of Cellular Therapy Integrated Services, and is board-certified in Internal Medicine, Medical Oncology and Hematology. He received his MD from the University of Rochester School of Medicine prior to Residency at the Case Western Reserve University/University Hospitals Case Medical Center. Additional Fellowships include those sponsored by the Leukemia Society of America and the American Cancer Society.

In 1980, Dr. Lazarus performed the first bone marrow transplant in the State of Ohio. He now heads several clinical trials at Case Western, at the National Center for Regenerative Medicine. His seminal impact in multiple aspects of transplantation was recognized in 1986 by his invitation to develop and chair the Blood and Marrow Transplant Committee of the National Cancer Institute, a position he held until 2003. Dr. Lazarus has over 400 publications including over 300 peer reviewed articles, 50 book chapters and 70 review articles, and is Editor of Blood Reviews and Bone Marrow Transplantation and he has won a variety of lifetime achievement, distinguished alumnus and cancer research awards as well.

  • Peter A. McSweeney, MD
    Colorado Blood Cancer Institute at Presbyterian/St. Luke's, Rocky Mountain Blood and Marrow Transplant Program, University of Colorado, Denver, CO

Dr. McSweeney is Clinical Associate Professor of Medicine and is board-certified in Internal Medicine, Hematology and Hematopathology. He earned his MD at the University of Otago Medical School in Dunedin, New Zealand. He completed his Residency and Fellowships at Wellington Public Hospital in New Zealand. In the US, he completed fellowships in clinical hematology, hematopathology and oncology at Fred Hutchinson Cancer Research Center (FHCRC), and then worked in clinical research at FHCRC and became an Assistant Professor at the University of Washington School of Medicine.

Dr. McSweeney was the clinical director and laboratory medical director at the University of Colorado's Blood and Marrow Transplant Program. He has been published numerous times and won many awards for his work in blood and marrow transplantation.

  • John M. Pagel, MD, PhD
    Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, University of Washington School of Medicine, Seattle, WA

Dr. Pagel is an Associate Professor of Medical Oncology and Associate Member in the Clinical Research Division of FHCRC. He received a PhD in microbiology and molecular genetics from the University of California, Irvine and his MD (magna cum laude) from Boston University School of Medicine. After a Post-doctoral as a Howard Hughes (News - Alert) Research associate at the University of California, San Francisco he went on to complete his residency in Internal Medicine at the University of California San Francisco and fellowship in Oncology at the University of Washington.

Dr. Pagel specializes in bone marrow transplant, leukemia and lymphoma and has received numerous awards, including the ASCO Young Investigator Award, Lymphoma Research Foundation Career Development Award, ASCO Career Development Award, University of California President's Award, and a Howard Hughes Post-Doctoral Research Award. Throughout his career, Dr. Pagel has published many abstracts and articles in a variety of publications, including Blood, Bone Marrow Transplantation, and the Proceedings of the National Academy of Sciences. He leads a number of studies of radioimmunotherapy as the principal investigator of leukemia clinical trials. Dr. Pagel has been instrumental in the historical development of the anti-CD45 antibody, which when radiolabeled with iodine-131 becomes Iomab™-B. He has conducted clinical trials in various hematologic malignancies, including the Phase II "-1432" AML trial which is the basis for proceeding into our larger pivotal trial.

The Company expects to make selective additions to the Iomab-B SAB in the future.

About Iomab™-B

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 will 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 is 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 Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is preparing a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second program, 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 the 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 Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.


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