On June 13, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), reported that the Medical College of Wisconsin has treated its first patient in a Phase 1 trial studying Actinium’s Actimab-A in combination with CLAG-M for patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) (Press release, Actinium Pharmaceuticals, JUN 13, 2018, View Source [SID1234527311]). This Phase 1 dose-escalation trial will study a single administration of Actimab-A following treatment of CLAG-M and will evaluate safety and tolerability, response rates, rates of bone marrow transplant (BMT), progression-free survival (PFS), and overall survival (OS).
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Dr. Mark Berger, Actinium’s Chief Medical Officer said, "We are grateful for all of the hard work that the team at MCW has put in to get to this important milestone. Actimab-A has demonstrated promising activity as a single agent in difficult to treat patient populations that we attribute to its targeting ability, potency and tolerability. We are excited to be leveraging these strengths of Actimab in a combination regimen to bring this potentially important therapy to a greater number of patients in indications that need improved outcomes. We are confident that the addition of Actimab to a salvage chemotherapy regimen has the potential to improve outcomes through improved response rates and by increasing the number of patients that can receive a bone marrow transplant."
Actimab-A is an ARC or Antibody Radio-Conjugate comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the radioisotope actinium-225. CD33 is a marker expressed on AML cells of virtually all AML patients. Actinium’s CD33 ARC has been studied in over 100 patients to date and is the only CD33 targeting agent being studied in a broad range of diseases in which the CD33 antigen is expressed including AML, myelodysplastic syndrome (MDS) and multiple myeloma. CLAG-M is a salvage chemotherapy regimen commonly used to treat patients with AML that consists of cladribine, cytarabine, filgrastim, and mitoxantrone.
Sandesh Seth, Actinium’s Chairman and CEO said, "Through the utilization of targeted radioisotopes we are able to add a new modality of treatment to a salvage cytotoxic chemotherapy regimen with the aim of improving efficacy. Further, we can apply our ARC technology to targeted conditioning to enable a bone marrow transplant that we will explore in this trial as well as our anticipated Actimab-MDS trial. In short time, our team has leveraged our capabilities to create the broadest CD33 program in terms of indications and addressable patient population. We believe our approach for this program which is supported by the strong hypothesis that combinations of targeted internalized radiation using ARC’s with chemotherapeutics is underpinned by a strong biologic rationale that can yield the best in class CD33 program".
About Our CD33 Program
We are developing a potentially best in class CD33 program using our ARC comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the alpha-particle emitter Actinium-225 (Ac225-lintuzumab). Our CD33 program was originally developed in conjunction with Memorial Sloan Kettering Cancer Center and has been studied in over 100 patients to date. CD33 is a marker shown to be expressed on cancerous blast cells of virtually all patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) and approximately 25%- 35% of patients with multiple myeloma. Actinium-225 is highly differentiated radioisotope that emits high amounts of energy through the release of four alpha-particles that can cause double-stranded breaks in DNA with known resistance mechanisms to Actinium-225. Given the limited distance of its energy in the body, it is potentially sparing of non-targeted cells leading to better tolerability and less toxicities.
Our CD33 program includes a Phase 2 clinical trial of for patients advanced over the age of 60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy an indication we have been granted Orphan Drug designation for in the US and EU. We are conducting a Phase 1 trial for patients with refractory multiple myeloma and planning to start a clinical trial for targeted conditioning prior to a bone marrow transplant for patients with high-risk MDS. We are studying Ac225-lintuzumab in combination with the chemotherapy regimen CLAG-M. We intend to continue to develop our CD33 program as a targeted therapy and for targeted conditioning of the bone marrow with Ac225-lintuzumab as a single agent and with novel combinations.