Leading Experts in the Field of AML Treatment and Bone Marrow Transplant to Discuss Available Treatment Options and Potential New Opportunities Including Actinium’s Iomab™-B at NY BIO CONference
Actinium’s Clinical Advisory Board Chair to Lead Panel Discussion
NEW YORK-- 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 participation in an upcoming panel discussion highlighting the potential role of Actinium’s products in the treatment of older refractory/relapsed acute myeloid leukemia (AML) patients. Leading experts in the field of AML treatment and bone marrow transplant will discuss available treatment options and potential new opportunities offered by Iomab™-B. On May 15, 2014 at 3:45PM at the NewYorkBIO-CONference in New York, Actinium’s Clinical Advisory Board Chairman Joseph Jurcic MD will lead a panel discussion titled “Can Older Refractory/Relapsed AML Patients Undergo Successful BMT without Entering CR First?”. Participants on the Panel will be:
- Joseph Jurcic, MD, Director, Hematologic Malignancies Section of the Hematology/ Oncology Division, Columbia University Medical Center
- Sergio Giralt, MD, Chief, Adult BMT Service, Memorial Sloan Kettering Cancer Center
- Markus Mapara, MD, PhD, Director, BMT Program, Columbia University Medical Center
- Mark Frattini, MD, PhD, Director of Research for the Hematologic Malignancies, Columbia University Medical Center
- Peter Maslak, MD, Chief, Hematology Laboratory Service, Memorial Sloan Kettering Cancer Center
- Sebastian Mayer, MD, Assistant Professor of Medicine, Weill Cornell Medical College; Assistant Attending Physician, New York-Presbyterian Hospital
Iomab™-B is a radiopharmaceutical candidate being developed to enable bone marrow transplants in older patients affected by relapsed and refractory AML, soon to enter a Phase 3 clinical trial. Currently, salvage chemotherapy is recommended in order to achieve a complete remission (CR) followed by allogeneic hematopoietic stem cell transplantation (HSCT), commonly known as bone marrow transplant. Radioimmunotherapy (RIT) added to reduced-intensity conditioning before HSCT offers the potential for increased anti-leukemic effects while minimizing toxicity associated with salvage chemotherapy and myeloablative HCT regimens. The panel will discuss potential advantages and disadvantages of older patients with refractory/relapsed AML being treated with reduced-intensity, RIT-enhanced HSCT in active disease versus current approaches.
“The poor response and toxicity of conventional salvage chemotherapy are barriers that often preclude stem cell transplantation for patients with relapsed and refractory AML,” said Dr. Jurcic. “The upcoming phase 3 study will definitively address whether conditioning for transplant that includes radioimmunotherapy is superior to conventional management strategies for this challenging group of patients.”
Dr. Jurcic, Actinium’s Clinical Advisory Board Chairman, is Director of the Hematologic Malignancies Section of the Hematology/Oncology Division and Professor of Medicine at Columbia University Medical Center in New York. He is a hematologist/oncologist focusing on the treatment of acute and chronic leukemias, myeloproliferative neoplasms, and myelodysplastic syndrome. His research interests include acute myeloid leukemia, radioimmunotherapy with alpha and beta particle-emitting radioisotopes, monoclonal antibody therapy for leukemia, development of novel small molecule inhibitors for leukemia and molecular monitoring of minimal residual disease. He received his medical degree from the University of Pennsylvania and completed his fellowship in Hematology-Oncology at Memorial Sloan Kettering Cancer Center. In addition to Chairing Actinium’s Clinical Advisory Board, Dr. Jurcic is the Lead Investigator for the Company’s Actimab-A trials.
The NewYorkBIO-CONference 2014 will be held Wednesday May 14 – Thursday May 15, 2014 at the Time Warner Center, 60 Columbus Circle, New York NY. Dr. Jurcic’s panel is on May 15, 2014 from 3:45-4:45 PM. NewYorkBIO supports the development and growth of New York State’s life science industry, and serves its members and the life science community by providing a network for public policy, industry advocacy, and community development. For further information, please visit newyorkbio.org.
Iomab™-B will be used in preparing patients for 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. 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.
Actimab-A, Actinium's second radiopharmaceutical program 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. The Company expects to make significant progress in the Phase 2 portion of the trial with interim results expected in late 2014. Actimab-A is being developed as a first line therapy and has attracted support from some of the leading experts at the most prestigious cancer treatment hospitals due to the potential of its safety and efficacy profile.
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.
Actinium Pharmaceuticals, Inc.
Evan Smith, CFA, 646-840-5442
VP Investor Relations and Finance
Source: Actinium Pharmaceuticals, Inc.
Released May 13, 2014