Actinium to Host Advisory Meeting at the 2014 ASBMT and CIBMTR Conference
Leading Transplant Experts to Review Preparations for Pivotal Phase III Trial of Actinium's Iomab(TM)-B Drug Candidate
NEW YORK, NY -- (Marketwired) -- 02/26/14 -- Actinium Pharmaceuticals, Inc. (OTCBB: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, will host an advisory meeting with leading bone marrow transplant experts during the combined annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) in Grapevine, Texas on Saturday, March 1, 2014. The Company will present an agreement reached with the Food and Drug Administration (FDA) on the design of a single pivotal Phase III trial for approval of Iomab™-B, Actinium's leading drug candidate. The advisory group will discuss the Iomab™-B Phase III trial design, formation of a Scientific Advisory Board for Iomab™-B and logistics of the Phase III trial.
"Having such a prominent group of transplant experts working with us on this trial will go a long way toward ensuring the best possible trial," said Dragan Cicic, MD, Chief Medical Officer of Actinium Pharmaceuticals. "We are not only developing a new drug but an entirely new paradigm in treatment of this patient population, and having people who in many ways define new treatment paradigms actively participate in the process is of enormous value to us."
Attendees of the meeting will include Richard Champlin, MD, Chair, Department of Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, TX; Sergio Giralt, MD, Chief Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center; Hillard Lazarus, MD, Disease Team Leader and Director, Novel Cell Therapy, University Hospitals Case Medical Center; Peter McSweeney, MD, Clinical Director and Laboratory Medical Director, Blood and Marrow Transplant Program, Colorado Blood Cancer Institute and Primary Investigator for Iomab™-B trials; and John Pagel, MD, PhD, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center.
"I am thrilled that we are moving closer to the final trial before potential approval for Iomab™-B," said John Pagel, MD, Primary Investigator for Iomab™-B. "This drug candidate has a potential to change the way we approach bone marrow transplants and expand their use to patients who would benefit from them the most but currently have very limited access to this lifesaving procedure."
Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant which is 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 study design of the pivotal trial is based on results of an earlier Phase 1/2 trial in which sixty percent of the older patients with refractory and relapsed AML exhibited disease free survival estimated at six months. 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 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 a bone marrow transplant 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 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. (OTCBB: ATNM) 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 conducting 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. For more information, please visit www.actiniumpharmaceuticals.com.
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.
Contact: Actinium Pharmaceuticals, Inc. Investor/Media Relations: Corey Sohmer (646) 459-4201 Email: email@example.com
Source: Actinium Pharmaceuticals, INC.
Released February 26, 2014