NEW YORK, Sept. 21, 2016 (GLOBE NEWSWIRE) — 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 today that the Company will host a webinar on Tuesday, September 27, 2016 at 9:00 AM ET to provide an update on the Actimab-A Phase 2 Clinical Trial. Details of the webinar are below:
Date: Tuesday, September 27, 2016
Time: 9:00 AM ET
Webinar Link: https://onecast.thinkpragmatic.com/ses/awQiM-9OD7Iysoul6ZD6BQ~~
“Since presenting our Phase 1 data on June 1, 2016, we have made progress on our Actimab-A program”, stated Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. “We look forward to providing an update on the Actimab-A Phase 2 trial that will include the protocol changes that have been agreed to by the FDA.”
Dr. Joseph Jurcic, M.D., Principle Investigator for the Actimab-A Phase 2 trial said, “Actimab-A is intended to treat patients over the age of 60 that are newly diagnosed with acute myeloid leukemia, which is a patient population with significant unmet medical needs. The results from the Actimab-A Phase 1 clinical trial showed an encouraging safety and efficacy profile that gives us great excitement for the Phase 2 clinical trial of Actimab-A.”
The Actimab-A Phase 2 clinical trial is expected to begin in 2016 and will enroll 53 patients bringing the total number of patients in this Phase 1/2 Actimab-A trial to 71. This multi-center, open-label, single-arm Phase 2 trial will enroll patients newly diagnosed with AML who are over the age of 60. The Company will also be incorporating into the Phase 2 trial protocol changes including the removal of low dose cytarabine, the mandated use of granulocyte colony-stimulating factors (GCSF) and the mandated use of Hydroxyurea based on the findings from its peripheral blast (PB) burden hypothesis which was derived from the two Phase 1 clinical trials conducted with Actimab-A in its Hum195-Alpha clinical program. Based on evidence that suggests that peripheral blasts prevent Actimab-A from reaching the bone marrow at optimal doses, the Company has mandated the use of Hydroxyurea to reduce the PB burden in patients above a certain key threshold. PB burden will serve as an inclusion criteria for the Phase 2 trial but it is not expected to exclude patients due to the ability of Hydroxyurea to reduce peripheral blasts. The end point of the Phase 2 trial will be complete response rate at up to 42 days after Actimab-A administration, where complete response is defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRp). A formal interim analysis is expected to occur in mid-2017.
Actimab-A, Actinium’s most advanced alpha particle immunotherapy (APIT) program, is being prepared for a Phase 2 clinical trial for patients newly diagnosed with AML over the age of 60. Actimab-A is being developed as a first-line therapy and it has attracted support from some of the leading experts at the most prestigious cancer treatment hospitals due to the potential of its safety and efficacy profile. Actimab-A consists of the monoclonal antibody, HuM195, and the radioisotope, actinium-225. Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. HuM195 is the humanized version of M195 and is a monoclonal antibody that targets CD33, which is abundantly found on myeloid leukemia cells. Both the alpha particle technology and HuM195 were initially developed at Memorial Sloan Kettering Cancer Center. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which has now been studied in almost 90 patients in four clinical trials.
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 radioimmunotherapy 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 is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory or 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 patients newly diagnosed with AML over the age of 60 in a single-arm multicenter trial.
Forward-Looking Statements 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.