New York, NY -- (ReleaseWire) -- 07/31/2014 -- Actinium Pharmaceuticals, Inc.,a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced the addition of Baylor Charles A. Sammons Cancer Center as a clinical trial site for Actimab-A. The center joins several other clinical trial sites currently participating in the Actimab-A Phase I/II trial to potentially address the rapid mortality and unmet medical need for older patients with newly diagnosed acute myeloid leukemia (AML).
M. Yair Levy, MD, Medical Director of Hematologic Malignancy Clinical Research, Baylor Research Institute, stated, “AML in the elderly is a disease that is difficult to treat with few therapeutic options. Through our participation, Baylor is pleased to be able to provide patients with the ability to enroll in the Actimab-A Phase I/II clinical trial and gain access to this innovative, targeted, low intensity therapy which is being evaluated to address this deadly disease.”
Kaushik J. Dave, Ph.D., President and CEO of the Company stated, “We are pleased to work with Baylor Charles A. Sammons Cancer Center, which is one of the largest oncology centers in the nation treating over 55,000 cancer patients every year. The selection reflects its commitment and significant experience in conducting clinical trials to evaluate the newest strategies for cancer prevention, diagnosis and treatment.”
The current Actimab-A clinical trial is titled “A Phase I/II Study of Low Dose Cytarabine and Lintuzumab-Ac225 in Older Patients with Untreated Acute Myeloid Leukemia” (ClinicalTrials.gov identifier NCT01756677). The Company expects to provide interim results around the same time as the American Society of Hematology (ASH) meeting in December 2014.
Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase I/II clinical trial. Based on Actinium’s alpha-particle immunotherapy (APIT) platform, Actimab-A consists of the CD33 antibody lintuzumab linked to the actinium-225 payload. Actimab-A has attracted support from leading experts at the prestigious and high-volume cancer treatment hospitals due to the potential of its safety and efficacy profile, as well as its potential potency, specificity and ease of use. Clinical trials are being conducted at world-class cancer institutions such as Memorial Sloan Kettering Cancer Center, Johns Hopkins Medicine, University of Pennsylvania Health System, Fred Hutchinson Cancer Research Center, MD Anderson Cancer Center and now the Texas Oncology-Baylor Charles A. Sammons Cancer Center. The Company expects interim Phase I/II clinical trial results in December 2014. Actimab candidates are in early development for other cancers.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (http://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.