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 released details from the previously closed NewYorkBIO-CONference panel session discussion titled “Can Older Refractory/Relapsed AML Patients Undergo Successful BMT without Entering CR First?”. The expert panel highlighted the significant unmet medical need for older patients with Acute Myeloid Leukemia (AML) and the role of radioimmunotherapy (RIT), with a specific focus on Iomab™-B. Relapsed/refractory AML patients lack options and have poor historical outcomes if given hematopoietic stem cell transplantation (HSCT) without first achieving complete remission, but the panel noted that Iomab™-B could change this paradigm.
The panelists clarified the potential role of Iomab™-B in extending these patients’ lives and discussed supportive clinical data, as well as practical considerations and the potential safety and tolerability of the drug candidate. The physician panel also elaborated on the rationale for the upcoming pivotal clinical trial for Iomab™-B, including justification for the design of the control arm of the study, as well as the primary and secondary endpoints.
To access the video webcast of the NewYorkBIO-CONference panel presentation, please select one of the following links: Iomab-B’s impact on AML, discussion highlights, or full-length video. You can also go to the Investors section of Actinium’s website at www.actiniumpharma.com under the Media Content tab.
The panel reviewed Iomab™-B survival data and discussed the potential for Iomab™-B to overturn the old paradigm that remission is required for HSCT providing an opportunity to address a broader patient population and at an earlier stage in treatment. Administration of Iomab™-B to older relapsed/refractory AML patients enables them to be given potentially curative HSCT, which they would otherwise not qualify for or be able to tolerate. Dr Sergio Giralt, Chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, discussed the pivotal trial design for Iomab™-B, in relapsed-refractory AML patients >55. This is a single-arm controlled study which has been planned with FDA guidance. Dr. Giralt explained that the control arm (physician’s choice of chemotherapy), was both sensible and necessary because it reflects current best practices, and physicians will be amenable to enrolling their patients in such a trial. He further stated that the control-arm patients that do achieve the primary endpoint of complete response will invariably be given HSCT, and those that do not achieve complete response will cross over into the study arm. Furthermore, Dr. Joseph Jurcic, Director, Hematologic Malignancies Section of the Hematology/ Oncology Division, Columbia University Medical Center explained that while physicians typically vary or customize their chemotherapy regimens for such patients, there is actually very little variability in survival, which is minimal. Therefore, we would not expect confounding variables within the control arm to diminish the separation from the study arm.
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.
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.