Monday, June 12, 2017 8:12:58 AM
Date : 06/12/2017 @ 7:00AM
Source : GlobeNewswire Inc.
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 Monday, June 12, 2017 at 8 AM EDT to provide an update on its pivotal Phase 3 trial for its lead drug candidate, Iomab-B. Iomab-B is a radioimmunotherapy that is intended, upon approval, to prepare and condition patients with active, relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above for a bone marrow transplant (BMT). The pivotal Phase 3 SIERRA trial is a 150-patient, randomized, controlled, multicenter trial that will compare Iomab-B followed by a BMT to physician’s choice of salvage chemotherapy, with a primary endpoint of durable complete remission (dCR) of at least 180 days.
Dr. Mark Berger, Chief Medical Officer of Actinium Pharmaceuticals said, “We have made significant progress with the SIERRA trial, which has been initiated at many of the top bone marrow transplant centers in the U.S. and we are in the process of initiating sites in Canada. We are fortunate to be working with such great transplant centers and physicians like Dr. Nath, who are focused on improving outcomes for patients with AML and those that receive a bone marrow transplant. We look forward to providing an update on the SIERRA trial and Iomab-B, which we believe has the potential to benefit patients given its targeted nature and simultaneous induction and conditioning capabilities.”
The webinar on June 12, 2017 will feature Dr. Rajneesh Nath, a principal investigator in the SIERRA trial, who is the Director of Bone Marrow Transplant and the Acute Leukemia Program at Banner MD Anderson Cancer Center. Participants from Actinium will include Dr. Mark Berger, Chief Medical Officer, Steven Price, Vice President of Clinical and Commercial Development and Sandesh Seth, Executive Chairman.
Webinar Participation Information:
Date: Monday, June 12, 2017
Time: 8 AM EDT
Webinar Link: https://onecast.Thinkpragmatic.com/ses/DID8Ygo2vc2bdaaDlWg97g~~
Sandesh Seth, Executive Chairman of Actinium said, “Patients over the age of 55 with active, relapsed or refractory AML have poor prognoses and lack effective treatment options that facilitate a bone marrow transplant. Iomab-B is the only targeted radioimmunotherapy in development for these patients in this indication and we believe we can transform bone marrow transplant with Iomab-B. The SIERRA trial is an important step in achieving this goal and we are excited to provide an update on the trial’s progress to date and upcoming milestones.”
About Iomab-B
Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients 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). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. In addition, Actinium is developing Actimab-M, which is being studied in patients with relapsed or refractory multiple myeloma in a Phase 1 clinical trial. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit http://www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, http://www.twitter.com/actiniumpharma.
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.
Contact:
Actinium Pharmaceuticals, Inc.
Steve O'Loughlin
Vice President, Finance and Corporate Development
mailto://soloughlin@actiniumpharma.com
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