Actinium Pharmaceuticals Announces Multiple Posters/Abstracts Accepted for 59th Annual American Society of Hematology Meeting Highlighting Company’s Drug Candidates and Technology Platform
- Data from ongoing Actimab-A Phase 2 clinical trial highlighting efficacy, safety profile and clinical strategy as a single agent targeting CD33 in patients with AML
- Studies highlighting enhanced killing of multiple myeloma cells by Actinium labeled daratumumab over naked daratumumab, a CD38 monoclonal antibody approved for treatment of patients with multiple myeloma
- Experimental results supporting the rationale for targeting CD33 in multiple myeloma
NEW YORK, Nov. 01, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells, announced today that three abstracts have been accepted at the 59th Annual American Society of Hematology (ASH) Meeting & Exposition being held December 9 – 12, 2017 in Atlanta, Georgia.
A poster presentation will highlight data from Actinium’s Phase 2 trial of Actimab-A in patients newly diagnosed with acute myeloid leukemia (AML). Details of the poster presentation are as follows:
A Phase 2 Study of Actinium-225 (225Ac)-Lintuzumab in Older Patients with Previously Untreated Acute Myeloid Leukemia (AML) Unfit for Intensive Chemotherapy
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Date: Sunday, December 10, 2017 Presentation
Time: 6:00 PM - 8:00 PM
Dr. Mark Berger, Actinium’s Chief Medical Officer said, “I am delighted to see our clinical and research progress presented at this year’s annual ASH meeting. This is the first time that data from Actimab-A as a single agent has been presented and we are excited that its potency as a single agent has surpassed our expectations with response rates greater than 50%. Given its simple administration via two thirty-minute infusions and minimal non-hematologic toxicities, we are confident in Actimab-A’s potential to improve outcomes for patients who are unfit for intensive chemotherapy and thus have few effective treatment options. The early data from the ongoing Phase 2 trial have allowed us to better understand Actimab-A’s myelosuppressive effects, which are a CD33 class effect. More importantly, these data have highlighted the strengths of Actimab-A, including the lack of veno-occlusive disease. These strengths will allow us to advance Actimab-A as a single agent or in combination with other regimens and also as a superior bridge to transplant in multiple indications given its ability to produce myelosuppression with very few extramedullary side effects. We intend to provide updates on these new and exciting initiatives for Actimab-A. In addition, we believe our course correction to a lower dose in the ongoing trial has potentially allowed us to address myelosuppression. ASH will be an invaluable opportunity that will allow us to present updated data and our exciting plans for the CD33 program to thought leaders in AML.”
A poster presentation will highlight the Company’s research activities with its Actinium-225 Technology Platform focused on the labeling of Daratumumab, an approved monoclonal antibody therapy targeting CD38 in patients with multiple myeloma, with the alpha emitting particle, actinium-225. Details of the poster presentation are as follows:
Actinium Labeled Daratumumab Demonstrates Enhanced Killing of Multiple Myeloma Cells over Naked Daratumumab
Session Name: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III
Date: Monday, December 11, 2017
Presentation Time: 6:00 PM - 8:00 PM
An online abstract has been accepted highlighting experimental results supporting the rationale for targeting CD33 in patients with multiple myeloma. Details for the online abstract are as follows:
CD33 Is Expressed in a Significant Subset of Multiple Myeloma Patients in the US and May Represent a Viable Therapeutic Target
Session Name: 651. Myeloma: Biology and Pathophysiology, excluding therapy
Abstracts for the 59th Annual American Society of Hematology Meeting can be accessed through ASH’s website (http://www.hematology.org/ ) starting at 9:00 AM ET on November 1, 2017.
Sandesh Seth, Actinium’s Chairman and CEO said, “In recent months, Actinium has focused on strengthening our clinical development, research and manufacturing capabilities and we are proud to see our efforts recognized at ASH. These abstracts/posters reporting on early clinical results from the Phase 2 Actimab-A trial and the data providing the basis for our myeloma trial, together signal our ability to uncover a highly differentiated and potentially best–in-class CD33 targeting asset. In addition, we also have a poster that showcases the ability of our Actinium-225 Technology Platform. We are excited to demonstrate our research capabilities by presenting our data on the enhanced killing power of actinium-225 labeled daratumumab compared to naked daratumumab. Daratumumab or Darzalex® is a blockbuster antibody therapy that targets CD38 in patients with multiple myeloma. This initiative showcases our strategy of offering potential partners the opportunity to license enhanced commercial monoclonal antibodies labeled with actinium-225. We will continue to strengthen our execution capabilities as we enter a critical period of clinical milestones for the Company in 2018 and 2019. The entire team at Actinium is energized to execute on our vision to become a leading company to provide therapies for safer myeloablation that can materially improve outcomes of bone marrow transplant and also for the treatment of patients with blood cancers with our proprietary technology. “
Actimab-A, Actinium's most advanced alpha-particle therapy product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML, age 60 and above, that are ineligible for standard induction chemotherapy. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 30-minute infusions that are given 7 days apart. 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 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 and the European Medicines Agency.
Actimab-M is being investigated in patients with refractory multiple myeloma. Multiple myeloma is a currently incurable cancer of plasma cells, which are white blood cells that produce antibodies. Actimab-M is currently being studied in a Phase 1 dose escalation study in up to 12 patients that is designed to establish safety, maximum tolerable dose and proof of concept. Actimab-M consists of actinium-225, an alpha-emitting radioisotope coupled to the anti-CD33 monoclonal antibody, HuM-195. CD33 has been shown to be expressed on myeloma plasmocytes in 25% to 35% of multiple myeloma patients and has also shown to be correlated with poorer outcomes.
About Our Actinium-225 Technology Platform
The Actinium-225 Technology Platform is a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with monoclonal antibodies (mAbs), which are large molecules capable of binding specifically to cancer cells. Actinium-225 emits significant energy, making it a potent treatment modality against targeted cancer cells and this energy only travels extremely short distances, limiting damage to healthy tissues. Due to the targeting of this energy by way of the mAbs bringing the actinium-225 directly to cancer cells, Actinium believes actinium-225 enabled therapies will result in potentially more effective and tolerable therapies.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. We are currently conducting clinical trials for our three product candidates, Iomab-B, Actimab-A and Actimab-M, as well as performing research on other potential drug candidates utilizing our proprietary actinium-2225 technology platform. Our most advanced product candidate, Iomab-B, is comprised of an anti-CD45 monoclonal antibody labeled with iodine-131. We are currently conducting a pivotal Phase 3 trial of Iomab-B for myeloablation and conditioning of the bone marrow prior to a bone marrow transplant for patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow transplant is a potentially curative treatment option for patients with AML and other blood cancers including leukemias, lymphomas and multiple myeloma as well as certain blood disorders. Upon successful completion of our Phase 3 clinical trial for Iomab-B we intend to submit this candidate for marketing approval in the U.S. and European Union. Our most advanced alpha-particle based therapy, Actimab-A, is an anti-CD33 monoclonal antibody conjugated with the alpha-particle actinium-225 (Ac-225). Actimab-A is currently in a Phase 2 clinical trial for patients over the age of 60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy. Actimab-M, our third product candidate, is the same anti-CD33 monoclonal antibody conjugated to Ac-225 administered at a different dose and dosing regimen. Actimab-M, is being studied in a Phase 1 trial for patients with refractory multiple myeloma. We expect our alpha-particle technology platform will generate additional drug candidates that we will progress in clinical trials ourselves and or out-license. More information available at www.actiniumpharma.com and Twitter feed @ActiniumPharma, 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.
Actinium Pharmaceuticals, Inc.
Principal Financial Officer
Marek Ciszewski, J.D.
Released November 1, 2017