M. Yair Levy, MD to Guide and Participate in Upcoming Pivotal Trial of Actinium’s Iomab™-B For Older Relapsed/Refractory Acute Myeloid Leukemia Patients
New York, NY -- (SBWIRE) -- 07/09/2014 -- Actinium Pharmaceuticals, Inc.,("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced the addition of M. Yair Levy, MD of Baylor to its Scientific Advisory Board (SAB) for Iomab™-B. Iomab™-B, the Company’s lead radioimmunotherapy asset, is entering a Phase 3 trial to potentially address the rapid mortality and significant unmet medical need for older patients with acute myeloid leukemia (AML) and well as in other cancer indications.
Dr. Levy is Medical Director, Hematologic Malignancy Clinical Research of the Texas Oncology-Baylor Charles A. Sammons Cancer Center in Dallas, Texas. He was previously on the Faculty at Sidney Kimmel Comprehensive Care Center at Johns Hopkins, after completing a Hematology Fellowship there. Dr. Levy is Board Certified in Medical Oncology and Internal Medicine. He is also a Clinical Assistant Professor of Internal Medicine at the Texas A&M College of Medicine.
Kaushik J. Dave, Ph.D., President and CEO of the Company stated, “We are gratified to add Dr. Levy to our newly formed SAB, which includes experts in the field of oncology, hematology, and bone marrow transplant. Texas Oncology is one of the largest oncology practices in the nation treating over 55,000 cancer patients every year, and Dr. Levy’s affiliation brings valuable perspective to the transplant physicians on our SAB as he is an experienced clinical trial researcher. The Texas Oncology-Baylor Charles A. Sammons Cancer Center is one of the ten largest bone marrow transplant centers in the United States.”
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 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. (http://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.