SOURCE: Actinium Pharmaceuticals

Actinium Pharmaceuticals

May 28, 2015 07:00 ET

Actinium Clinical Update on Actimab-A Provided at Targeted Alpha Therapy Symposium

Clinical Advisory Board Chairman Dr. Joseph Jurcic Presented Data From Ongoing Actimab-A Phase I/II Clinical Trial

NEW YORK, NY--(Marketwired - May 28, 2015) - Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, recently sponsored the 9th Symposium on Targeted Alpha Therapy, held in Warsaw, Poland on May 19-21. Symposium organizers included the Institute for Transuranium Elements of the European Commission and other sponsors include the U.S. Department of Energy. The latest developments in alpha emitter therapy were discussed, such as clinical experiences with alpha emitters including actinium.

Dr. Joseph G. Jurcic, Professor of Medicine at Columbia University Medical Center and Chairman of Actinium's Clinical Advisory Board, presented "Targeted Alpha-Particle Therapy with Actinium-225 (225Ac)-Lintuzumab for Acute Myeloid Leukemia (AML) Alone and in Combination with Low-Dose Cytarabine (LDAC)". A review of the target (CD33), the antibody (Lintuzumab, also called HuM195) and the payload (actinium-225, a potent alpha-emitter) was given. He also provided a clinical update on the ongoing Phase I/II study of Actimab-A, the Company's alpha-emitting radiolabeled antibody, being developed for older patients with newly diagnosed acute myeloid leukemia (AML).

The Company recently announced that it began the fourth and last cohort (2.0 μCi/kg per dose) in this trial. It is expected that the MTD will be reached at this level, and thereafter the Company will move to the Phase 2 portion of the trial. Thus far, Actinium has consistently observed anti-leukemic activity across four clinical trials of its HuM195-actinium-225 construct, including two trials of its first generation compound, Bismab-A. The safety profile also appears to be acceptable, with moderate toxicities commonly seen with even mildest treatments in these extremely sick patients who presently has few effective therapeutic options.

Dr. Jurcic is Director of the Hematologic Malignancies Section of the Hematology/Oncology Division and Professor of Clinical Medicine at Columbia University Medical Center. He is a hematologist/oncologist focusing on the treatment of acute and chronic leukemias, myeloproliferative neoplasms, and myelodysplastic syndrome. His research interests include acute myeloid leukemia, radioimmunotherapy with alpha and beta particle-emitting radioisotopes, monoclonal antibody therapy for leukemia, development of novel small molecule inhibitors for leukemia and molecular monitoring of minimal residual disease. He is the primary investigator for the current Actimab-A clinical trial and Clinical Advisory Board Chairman. He received his medical degree from the University of Pennsylvania and completed his fellowship in Hematology-Oncology at Memorial Sloan-Kettering Cancer Center.

About Actimab-A
Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 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, MD Anderson Cancer Center, Johns Hopkins Medicine, Columbia University Medical Center, University of Pennsylvania Health System, Fred Hutchinson Cancer Research Center, and the Texas Oncology-Baylor Charles A. Sammons Cancer Center. Actimab candidates are in early development for other cancers.

About Iomab-B
Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. 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).

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 products are 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 product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, 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.

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