On February 28, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported 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) (Press release, Actinium Pharmaceuticals, FEB 28, 2018, View Source [SID1234524220]). 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.
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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.