- Webinar topics will cover FDA Advisory Panel on Mylotarg, developments with other CD33 targeted therapies and update on Actimab-A
- Webinar to be led by Dr. Joseph Jurcic, Director of Hematologic Malignancies at Columbia University Medical Center and Dr. Mark Berger, Actinium’s Chief Medical Officer who was the lead clinician on Mylotarg’s initial approval in 2000
NEW YORK, July 06, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options will hold a webinar focused on its Actimab-A program and recent developments related to CD33 targeted Acute Myeloid Leukemia (AML) therapies. Until this year, Mylotarg, which targets CD33, was the only drug approved for the treatment of AML in several decades. The drug was withdrawn from the market and the sponsor (Pfizer) recently resubmitted BLA to the FDA and an FDA Advisory Committee Meeting will be held on July 11, 2017. The CD33 antigen is a validated target that is the focus of drug development programs from several companies using different antibody based approaches including; naked antibodies (Boehringer Ingelheim), bispecific (Amgen, Johnson and Johnson/Amphivena), antibody drug conjugates (Immunogen, Pfizer, and, until recently, Seattle Genetics) and radioimmunotherapy (Actinium and Bayer).
Dr. Mark Berger, Actinium’s Chief Medical Officer said, “Having led the original approval of a CD33 targeting therapy in AML, I know firsthand that CD33 is an excellent target given its high expression rates in AML and specificity for hematologic cells. Several recent events in the CD33 AML field bolster our belief that Actimab-A, which outside of Mylotarg is the most advanced development program targeting CD33, has the potential to be a best in class asset. While several technological approaches are being studied, we believe that our actinium-225 radioisotope approach may be most beneficial to patients based on the promising efficacy and safety profile that has been demonstrated in multiple clinical trials to date. In addition, we look forward to providing an update on the Actimab-A phase 2 trial which is on track for interim results later this year in light of these developments.”
Webinar Information:
Date: Thursday, July 13, 2017 Time: 8 AM EDT Webinar Link: https://onecast.thinkpragmatic.com/ses/xDpWQu...0Ox1VPkA~~
| Upcoming Actimab-A Milestones | |||
| Interim Analysis | 2H:2017 | ||
| Complete Patient Enrollment | 1H:2018 | ||
| Top Line Data Results | 1H:2018 | ||
About Actimab-A
Actimab-A, Actinium's most advanced alpha-particle based product candidate, is currently being studied in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with acute myeloid leukemia (AML) age 60 and above. AML is a cancer of the blood and bone marrow that affects red blood cells, white blood cells and platelets. A majority of patients with AML express CD33, a protein expressed on the cell surface. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer cells. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225 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. Actimab-A is being developed as a first-line therapy as a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in over 100 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration. There currently exists a well-defined and urgent medical need for effective therapies for patients newly diagnosed with AML who are 60 years and older.
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 www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, 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 Principal Financial Officer soloughlin@actiniumpharma.com Investor Relations Marek Ciszewski, J.D. 949.574.3860 ATNM@liolios.com
