- Protocol changes to the control arm of the pivotal Phase 3 trial for Iomab-B well received at the Company’s investigator meeting and by Iomab-B’s scientific advisory board
- Product theater presentations featuring heads of transplant at Memorial-Sloan Kettering and Weill Cornell highlighted the myeloablative capabilities of Actinium’s CD33 program Actimab-M and Actimab-MDS clinical trials
NEW YORK, Feb. 28, 2018 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") highlighted its progress and activity at the recently concluded BMT Tandem Meetings, the combined annual meetings of the American Society of Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Actinium’s lead product candidate, Iomab-B, is currently being studied in a pivotal Phase 3 trial as a myeloablative conditioning agent prior to a bone marrow transplant. Recently, Actinium announced that it had amended the protocol of its pivotal Phase 3 SIERRA trial to expand the number of salvage chemotherapy agents included in the control arm. The response from clinical trial principal investigators to this change has been positive. In addition, Actinium recently announced that it had activated Stony Brook University as the 16th clinical trial site in the SIERRA trial.
Dr. Mark Berger, Chief Medical Officer of Actinium said, “As we have made significant progress with the SIERRA trial, we recognized that the regimens in the control arm needed to be expanded, based largely on feedback from our investigators and advisory board. We believe that investigators recognized the imbalance between groups, evidenced by the crossover component of the trial, so we were eager to make these changes, which have been very well received by trial investigator. As a result, we believe physicians have a more receptive view to the control arm that will lead to accelerated rates of enrollment. Once again, the BMT Tandem Meetings have proved to be an invaluable conference for us and we look forward to capitalizing on the positive momentum we generated in our interactions with the transplant community to complete enrollment of the SIERRA trial.”
In addition, Dr. Sergio Giralt, Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center and Dr. Koen van Besien, Director, Stem Cell Transplant Program at Weill Cornell Medical Center highlighted trials from the Company’s CD33 program in the Company’s well attended product theater. Dr. Giralt highlighted the myeloablative potential of Actinium’s CD33 prior to a bone marrow transplant for patients with multiple myeloma that is being studied in the Actimab-M Phase 1 trial. Currently, Actimab-M is the only trial for a CD33 targeting agent and alpha-particle based therapy for multiple myeloma. Dr. van Besien also highlighted the myeloablative potential in patients with high-risk myelodysplastic syndrome (MDS) with a p53 genetic mutation that is expected to be studied in a planned Phase 2 trial for Actimab-MDS. The Actimab-MDS trial will be conducted with the MDS Clinical Research Consortium and this trial will be led by Dr. Gail Roboz, Director of the Leukemia Program and Professor of Medicine at Weill Cornell New-York Presbyterian Hospital and her colleagues at the Cleveland Clinic, Dana-Farber Cancer Institute, Johns Hopkins, MD Andersen Cancer Center, Moffitt Cancer Center and Weill Cornell.
Sandesh Seth, Actinium’s Executive Chairman said, “We were incredibly excited for Tandem this year as we were able to showcase our multi-disease, multi-target pipeline focused on myeloablation for the first time at this conference. There are great advances being made in the field of bone marrow transplant and we are excited to be at the forefront of improved myeloablation, which is a critical aspect of the patient’s journey and where we can make significant impact to patient access and outcomes. We came away from the conference incredibly excited by the opportunities that we see emerging in transplant and cell therapies that our technologies and growing pipeline are ideally suited for and also the opportunity to be the market leader providing superior conditioning in this growing area.”
About BMT Tandem Meetings
Annually, the BMT Tandem Meetings are the largest gathering in North America of worldwide experts in blood and marrow transplant patient care, clinical investigation and laboratory research. Over 3,000 transplant physicians in over 500 transplant centers from >50 countries participate in the CIBMTR. The ASBMT has a membership of over 2,300 clinicians and researchers. By combining our meetings, we expect over 3,200 participants at next year’s meetings representing more than 50 countries, with approximately 20% coming from outside the United States.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for potentially superior myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. Our targeted therapies have demonstrated the potential to result in significantly improved access to bone marrow transplant with better outcomes, namely increased marrow engraftment and survival. Our targeted therapies are ARC’s or Antibody Radio-Conjugates that combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. We have four clinical trials based on our AWE or Actinium Warhead Enabling Technology Platform that utilizes the isotope Actinium-225 (Ac225) which emits alpha particles. In addition, our most advanced product candidate, Iomab-B, an ARC developed by the Fred Hutchinson Cancer Research Center, is comprised of an anti-CD45 monoclonal antibody labeled with iodine-131. We are currently conducting a pivotal Phase 3 trial of Iomab-B for myeloablation and conditioning of the bone marrow prior to a bone marrow transplant for patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow transplant is a potentially curative treatment for patients with AML and other blood cancers including leukemias, lymphomas and multiple myeloma as well as certain blood disorders. Iomab-B has been tested in several of these other cancers with over five hundred patients treated in several Phase 1 and 2 trials with promising results. Upon successful completion of our Phase 3 clinical trial for Iomab-B we intend to submit this candidate for marketing approval in the U.S. and European Union where it has been designated as an Orphan Drug. We are also developing a potentially best in class CD33 program using an ARC comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Our most advanced CD33 program candidate, Actimab-A, is currently in a Phase 2 clinical trial for patients advanced over the age of 60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy. Actimab-A also has Orphan Drug designation in the US and EU. Actimab-M, our second CD33 program ARC, is being studied in a Phase 1 trial for patients with refractory multiple myeloma. Actinium is also planning a Phase 2 trial for Actimab-MDS, our third CD33 program candidate, as a conditioning regimen prior to a bone marrow transplant for patients with MDS that have a p53 genetic mutation. Our Phase 1 trial studying Actimab-A with CLAG-M is our fourth CD33 program clinical trial for patients with relapsed or refractory AML. Our AWE or Actinium Warhead Enabling Technology Platform, originally developed in conjunction with Memorial Sloan Kettering Cancer Center, is focused on leveraging Actinium’s know how and intellectual property to create additional ARC drug candidates by labeling 225Ac to targeting moieties that we will either progress in clinical trials ourselves or out-license.
More information is available at www.actiniumpharma.com and our Twitter feed @ActiniumPharma, www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other “forward-looking statements” within the meaning of the “safe-harbor” provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company, which the Company undertakes no obligation to update. These statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium’s products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the “SEC”), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contact:
Actinium Pharmaceuticals, Inc.
Steve O'Loughlin
Principal Financial Officer
soloughlin@actiniumpharma.com
Investor Relations
Marek Ciszewski, J.D.
949.574.3860
ATNM@liolios.com