Tuesday, February 07, 2017 9:05:56 AM
Date : 02/07/2017 @ 8:00AM
Source : GlobeNewswire Inc.
- Phase 1 trial will evaluate Actimab-M in treating patients with multiple myeloma who are unresponsive to currently available therapies
“I am very excited to lead in the development of this novel and promising approach,” said Dr. M. Yair Levy of Texas Oncology - Baylor Charles A. Sammons Cancer Center. “Relapsed and refractory multiple myeloma is an area of high unmet medical need that we hope to address with Actimab-M. Myeloma is a very radiosensitive cancer, and does not present with the neutropenia and thrombocytopenia of AML. I would expect tolerability of this treatment to be better in this disease. Based on my previous experience with Actimab-A in AML and my research in the area of multiple myeloma, I believe that this targeted treatment could prove efficacious and be a part of our growing armamentarium against this disease.”
Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals said, “We are incredibly excited to see the initiation of this trial for Actimab-M in multiple myeloma. Not only does this mark the beginning of the expansion of our clinical pipeline beyond AML, it also demonstrates the broad applicability of our radioimmunotherapy technologies that we intend to progress into new indications and patient populations. Further, this reinforces Actinium’s commitment to developing therapies for patients with unmet needs. We look forward to providing updates as this trial progresses.”
About Multiple Myeloma
Multiple Myeloma is a blood cancer characterized by malignant transformation of the type of white blood cells called plasmocytes. These cells accumulate in the bone marrow and eventually lead to serious bone and kidney damage. Multiple Myeloma is the second most commonly diagnosed blood cancer after Non-Hodgkin Lymphoma with estimated about 30,000 new cases per year in the US. Almost 100,000 people in the US currently live with the disease. Average age at diagnosis is 70, and only 2% of cases occur in people younger than 40 years. There is currently no cure for Multiple Myeloma, although a number of drugs have been approved for treatment of the disease. However, most patients eventually stop responding to available treatments, which results in a high unmet medical need for relapsed and refractory forms of the disease.
About Actimab-M
Actimab-M is comprised of the anti-CD33 monoclonal antibody HuM-195 coupled to actinium 225, an alpha-particle emitting radioisotope, and is the same construct of Actinium’s Actimab-A, which is currently being studied in a Phase 2 clinical trial in patients newly diagnosed with acute myeloid leukemia (AML) who are over the age of 60. Actimab-A is being studied in AML at fractionated doses of 2.0 µCi/Kg administered via infusion on day 1 and day 7 as a single cycle while Actimab-M is being studied in multiple myeloma as a single infusion up to 1.0 µCi/Kg for up to 8 cycles not to exceed 4.0 µCi/Kg total per patient. The Phase 1 trial for Actimab-M is a multicenter, open label, dose-escalation study. Patients will be administered a starting dose level of 0.5 µCi/Kg of Actimab-M via infusion on day 1 of each cycle for up to 8 cycles with each cycle lasting 42 days. If this dose level is deemed safe, a second dose level of 1.0 µCi/kg will be explored for up to 4 cycles also of 42 days per cycle. Total dose received per patient is not to exceed 4.0 µCi/kg. In the event of dose limiting toxicities (DLTs) at the 0.5 µCi/Kg dose level, a dose level of 0.25 µCi/Kg will be explored. The Phase 1 trial will estimate maximum tolerated dose (MTD), assess adverse events, measure response rates (objective response rate, complete response rate, stringent complete response rate, very good partial response rate and partial response rate) as well as progression free survival (PFS) and overall survival (OS).
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
Recent ATNM News
- Actinium Pharmaceuticals Announces Publication of Results from the Phase 3 SIERRA Trial of Iomab-B in the Journal of Clinical Oncology • PR Newswire (US) • 09/20/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/05/2024 09:15:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/05/2024 11:30:34 AM
- Actinium Provides Regulatory Update on Planned BLA Filing and Future Plans for Iomab-B in the U.S. • PR Newswire (US) • 08/05/2024 11:00:00 AM
- Actinium Expands Patent Coverage Over Iomab-ACT, its Next-Generation Targeted Radiotherapy Conditioning Agent, for Gene Edited Stem Cell-Based Therapies for Non-Malignant Indications • PR Newswire (US) • 08/01/2024 12:00:00 PM
- Actinium Announces FDA Clearance of Iomab-ACT Targeted Conditioning IND Application for Sickle Cell Disease Patients Undergoing Bone Marrow Transplant in Collaboration with Columbia University • PR Newswire (US) • 07/25/2024 12:45:00 PM
- Actinium Pharmaceuticals to Present at the 3rd Annual Targeted Radiopharmaceuticals Summit US • PR Newswire (US) • 07/25/2024 11:30:00 AM
- Actinium Presents First Ever Data Demonstrating Actimab-A in Combination with Leading Menin Inhibitors Leads to Anti-Tumor Control and Potent Leukemic Cell Killing in Preclinical Acute Myeloid Leukemia Models at the 2024 EHA Congress • PR Newswire (US) • 06/17/2024 12:00:00 PM
- Actinium Highlights Oral Presentation at EHA 2024 Annual Congress Featuring Improved Outcomes in TP53 Positive Patients Receiving Iomab-B in the Phase 3 SIERRA Trial • PR Newswire (US) • 06/14/2024 12:30:00 PM
- Actinium Announces Results of Actimab-A + CLAG-M Combination Trial Highlighted in Oral Presentation at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting • PR Newswire (US) • 06/11/2024 12:30:00 PM
- Actinium Highlights Mutation Data from the Phase 3 SIERRA Trial of Iomab-B and Novel Linker Technology to Support Solid Tumor Antibody Radiation Conjugate Development at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting • PR Newswire (US) • 06/10/2024 12:30:00 PM
- Actinium to Host KOL Webinar to Discuss Iomab-ACT Commercial CAR T-Cell Therapy Trial Design, Objectives and Potential Market Opportunity • PR Newswire (US) • 05/15/2024 12:30:00 PM
- Actinium Announces Oral Presentation Detailing Improved Survival Outcomes in TP53 Positive Patients at the EHA 2024 Annual Congress and Presentation of Long-Term Efficacy Results in Older Patients Receiving an Iomab-B Led Bone Marrow Transplant in the Phas • PR Newswire (US) • 05/14/2024 10:38:00 PM
- Actinium Announces Multiple Abstracts Highlighting its Antibody Radiation Conjugates Iomab-B and Actimab-A and Novel Linker Technology for Solid Tumors Accepted for Presentation at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting • PR Newswire (US) • 05/13/2024 12:30:00 PM
- Actinium Announces KOL Webinar to Highlight Recently Announced Iomab-ACT Trial with Leading FDA Approved Commercial CAR T-Cell Therapy Being Led by the University of Texas Southwestern • PR Newswire (US) • 05/07/2024 12:00:00 PM
- Actinium Highlights Ability of Iomab-B to Overcome High-Risk TP53 Mutation Resulting in Significant Improvement in Overall Survival in Patients with Active Relapsed Refractory AML at the European Bone Marrow Transplant Annual Meeting • PR Newswire (US) • 04/18/2024 12:00:00 PM
- Actinium Announces Iomab-B Phase 3 SIERRA Trial Results Demonstrating Survival Benefit in High-Risk Relapsed or Refractory Acute Myeloid Leukemia Patients with TP53 Mutations Accepted for Oral Presentation at the 50th European Bone Marrow Transplant Annual • PR Newswire (US) • 04/01/2024 12:00:00 PM
- Actinium Announces Clinical Trial to Study Iomab-ACT Targeted Radiotherapy Conditioning with Leading FDA Approved Commercial CAR T-Cell Therapy • PR Newswire (US) • 03/26/2024 11:18:00 AM
- Actinium Pharmaceuticals Launches Actinium-225 Focused Strategic Initiative to Leverage Proprietary Cyclotron Based Manufacturing Technology to Address Growing Market Demand • PR Newswire (US) • 03/11/2024 11:30:00 AM
- Actinium Announces Iomab-B Markedly Increases Long Term Survival in Patients 65 Years or Older with Active Relapsed or Refractory AML in the Phase 3 SIERRA Trial at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMT • PR Newswire (US) • 02/26/2024 12:30:00 PM
- Actinium Highlights Improved Survival with Iomab-B in TP53 Positive Relapsed Refractory Acute Myeloid Leukemia Patients in the SIERRA Trial and Other Presentations at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIB • PR Newswire (US) • 02/23/2024 12:30:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/09/2024 09:30:19 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/06/2024 05:15:04 AM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/02/2024 10:03:47 PM
- Actinium Announces Acceptance of Five Abstracts for Presentation at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR® • PR Newswire (US) • 01/02/2024 12:30:00 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM