Newswise — When stem cell transplant first became part of standard treatment for certain cancers and blood diseases twenty years ago, individuals older than 60 were rarely considered for the procedure. Today, age is no longer a barrier to this potentially life-saving therapy – today most patients affected by blood cancers such as acute myeloid leukemia (AML) needing this treatment, are over 60 years old. A new approach is being investigated to help these older patients who are undergoing these types of treatments to achieve better outcomes.
Dr. Hillard Lazarus and other cancer physicians cross the US are preparing for an upcoming Phase III study investigating the potential of Iomab-B (Actinium Pharmaceuticals, Inc.) in hematopoietic stem cell transplant (often referred to as bone marrow transplant). The drug called Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody coupled with an 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.
Researchers at Actinium found that the 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.
Dr. Lazarus can discuss the following: • Challenges in treating older relapsed/refractory patients • Explain limitations on current care • How does Iomab-B work?• What have earlier studies for the drug demonstrated?• What are its benefits for potential for overall survival/quality of life?• Next steps for trials using Iomab-B
About Dr. Hillard Lazarus Dr. Lazarus performed the first bone marrow transplant in Ohio in 1976. His seminal impact in multiple aspects of transplantation was recognized in 1986 with an invitation to develop and chair the Blood and Marrow Transplant Committee of the National Cancer Institute, a position he held until 2003. He now heads several clinical trials at the National Center for Regenerative Medicine (CWRU). He has over 500 publications and has won a variety of lifetime achievement, distinguished alumnus, and cancer research awards, in addition to fellowships sponsored by the Leukemia Society of America and the American Cancer Society.
About Bone Marrow Transplants: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.
About Iomab-BIomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. Actinium Pharmaceuticals 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.
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