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 addition of Richard E. Champlin, M.D. of MD Anderson Cancer Center to its Scientific Advisory Board (SAB) for Iomab™-B, the Company’s lead radioimmunotherapy asset which is preparing to enter a Phase III pivotal trial. MD Anderson is one of the world’s most respected centers devoted exclusively to patient care, research, education and prevention. For 10 of the past 12 years, MD Anderson has ranked No. 1 in cancer care in the “Best Hospitals” survey published by U.S. News & World Report.
Dr. Champlin is in his twenty-fifth year at MD Anderson Cancer Center in Houston, Texas. He holds the titles of Chair, Department of Stem Cell Transplantation and Cellular Therapy; Professor of Medicine; and Associate Division Head, Division of Cancer Medicine. As an international leader in the field of hematopoietic stem cell transplantation (HSCT), Dr. Champlin pioneered the use of donor transplants and lower doses of chemotherapy, reducing mortality rates along the way. Under his leadership, the MD Anderson HSCT program grew to become the largest in the world.
Dr. Champlin commented, “Targeted monoclonal antibody directed radio-immunotherapy has enormous promise for treatment of acute myeloid leukemia. Based on encouraging Phase I/II data, I am excited to work closely with Actinium to support their efforts to move Iomab-B into a Phase III trial for AML, as well as advances in other potential indications.”
Kaushik J. Dave, Ph.D., President and CEO of the Company stated, “We are fortunate to include Dr. Champlin in our newly formed SAB, which includes experts in the field of oncology, hematology, and bone marrow transplant. Dr. Champlin has played a formative role in the evolution of HSCT, and he runs the largest bone marrow transplant service in the world. His experience and perspectives will benefit the continued development of Iomab-B. As an institution, MD Anderson is one of the largest oncology practices in the nation treating over 120,000 people last year and enrolling nearly 7,600 participants in clinical trials.”
Dr. Champlin is board-certified in Internal Medicine, Medical Oncology and Hematology and received his M.D. (Alpha Omega Alpha) from the University of Chicago Pritzker School of Medicine prior to Residency and Fellowship at the University of California, Los Angeles. Additionally, Dr. Champlin has published approximately 700 original scientific and clinical research articles. He has Chaired or been a member of a multitude of professional organizations and committees, including Founding President of the American Society for Blood and Marrow Transplantation, Past Chair of the Center for International Blood and Marrow Transplantation Research, and is currently on the US Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation. Awards include the John Mendelsohn Lifetime Scientific Achievement Award of MD Anderson Cancer Center, Division of Cancer Medicine and the Lifetime Achievement Award of the American Society for Blood and Marrow Transplantation.
The Company’s SAB members will guide the continuing clinical development of Iomab-B, as Advisors, Principal Investigators, 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 and a secondary endpoint of overall survival at one year.
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.