|Actinium’s Actimab-A High Response Rates Presented at 2015 ASCO Annual Meeting Clinical Advisory Board Chairman Dr. Joseph Jurcic Presents Data from Ongoing Actimab-A Phase I/II Clinical Trial|
|Friday, 29 May 2015 18:34|
NEW YORK, NY –- Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced its poster and abstract at ASCO 2015, the 51st Annual Meeting of American Society of Clinical Oncology, held in Chicago on May 29 – June 2. Data will be presented from the Company’s ongoing multi-center Phase 1/2 Study for Actimab-A for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in elderly patients.
Clinical data from the first three cohorts, totaling 12 patients, will be discussed. Two Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi) and one patient achieved complete remission with incomplete platelet count recovery (CRp), for a combined overall response rate of 25% among all patients and 67% among patients treated at the highest dose level to date. Patients ranged from 68 to 87 years of age, all with high- or intermediate-risk cytogenetics; half of them had prior MDS therapy. Dose limiting toxicities were limited to one patient with prolonged myelosuppression. No extramedullary dose limiting toxicities were observed. Patients had high pre-treatment leukemia burdens of up to 88% in the bone marrow, and half had blast reductions >50% after Actimab-A treatment. The Company also recently began the fourth and last cohort (2.0 μCi/kg per dose) in the Phase I portion of this trial.
"We have seen dramatic reductions in bone marrow blasts after just one cycle of low-dose cytarabine and Actimab-A, much more so than would be expected with chemotherapy alone”, stated Joseph Jurcic, MD, Director of the Hematologic Malignancies Section of the Hematology/Oncology Division of Columbia University Medical Center in New York and lead author of the poster and abstract. “Moreover, these blast reductions have led to objective responses in a group of older patients with AML who would not benefit from intensive chemotherapy approaches. Actimab-A could play a major role in the treatment of this particularly challenging group of patients who currently have no standard treatment options." Further details on Dr. Jurcic’s poster presentation are below.
Title: Phase I trial of α-particle therapy with actinium-225 (225Ac)-lintuzumab (anti-CD33) and low-dose cytarabine (LDAC) in older patients with untreated acute myeloid leukemia (AML). (ASCO Abstract #7050)
Date/Time: Sunday May 31, 2015, 8:00 AM – 11:30 AM
Location: McCormick Place, Chicago, IL; Poster Board #39 in S Hall A
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.
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.
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.
David Gould, MD
SVP, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.