On February 4, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that the Medical College of Wisconsin (MCW) has started dosing patients in the second cohort of its novel trial of Actimab-A in combination with CLAG-M in patients with relapsed or refractory AML or Acute Myeloid Leukemia (Press release, Actinium Pharmaceuticals, FEB 4, 2019, View Source [SID1234533052]). This trial is evaluating the impact that the addition of targeted internalized radiation via Actimab-A to the salvage chemotherapy regimen CLAG-M will have on safety and tolerability, response rates, rates of BMT or bone marrow transplant, PFS or progression-free survival, and OS or overall survival.
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Dr. Mark Berger, Chief Medical Officer of Actinium, said, "This trial represents an exciting advancement of our CD33 program that is aligned with our clinical strategy to pursue combinations utilizing our ARC drug candidates. We are pleased to be moving ahead with MCW to the second cohort of this trial and we are optimistic that our ARC combination strategy will have a positive impact on patient outcomes by improving response rates, duration of responses and/or increasing the rate of patients receiving a bone marrow transplant. Chemotherapy and external radiation are routinely used in combination in several cancers but despite being radiation sensitive, AML is not treated with external radiation given its diffuse nature. Therefore, the ability to deliver radiation internally in a targeted fashion to AML cells with potency and tolerability gives us great confidence in our ARC approach. In addition, this trial is particularly important as AML patients with relapsed or refractory disease face a poor prognosis with limited treatment options."
In this Phase 1 combination trial patients are administered the salvage chemotherapy regimen CLAG-M, which consists of cladribine, cytarabine, filgrastim, and mitoxantrone, followed by a single dose of Actimab-A. Actimab-A is an ARC or Antibody Radiation-Conjugate that consists or the CD33 targeting monoclonal antibody lintuzumab labelled with the alpha-particle emitting isotope Ac-225 or Actinium-225. In the first dose cohort, patients received 0.25 uCi/kg of Actimab-A. This combination trial is designed as a 3+3 dose escalation study. No dose limiting toxicities (DLTs) were reported in the first patient cohort. As a result, and per the study protocol, the Institutional Review Board (IRB) at MCW has authorized the initiation of the second dosing cohort, in which patients will receive 0.50 uCi/kg of Actimab-A. Assuming no DLTs are observed in the second cohort, three patients will be treated and the study will progress to the third and final cohort will study Actimab-A at a dose of 0.75 uCi/kg.
Sandesh Seth, Actinium’s Chairman and Chief Executive Officer of Actinium, said, "In recent months, Actinium’s R&D and clinical teams have worked together to identify opportunities to further utilize our ARCs in combination with other therapeutic modalities. As a result, we are exploring multiple R&D and clinical initiatives with ARC based combination therapies. With the ARC combination strategy solidified as a corporate focus, we are delighted to see this positive progress from our first Actimab-A combination trial with CLAG-M. We are confident that the use of targeted radiation will prove synergistic with multiple modalities and open several therapeutic opportunities that are not possible with any other technology. We look forward to making continued progress on this front including the planned clinical trials with Actimab-A and venetoclax."