On February 6, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), reported that the Company is initiating a new clinical trial that will study Actimab-A in combination with CLAG-M for patients with relapsed or refractory acute myeloid leukemia (AML) (Press release, Actinium Pharmaceuticals, FEB 6, 2018, View Source [SID1234523752]). CLAG-M is a salvage chemotherapy regimen that consists of cladribine, cytarabine, and filgrastim with mitoxantrone for patients with relapsed or refractory AML. The combination trial will be a Phase 1, dose-escalation study that will be conducted at the Medical College of Wisconsin by principal investigator Dr. Ehab Atallah.
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Dr. Mark Berger, Actinium’s Chief Medical Officer said, "Relapsed and refractory AML patients unfortunately have limited treatment options that have little clinical benefit for patients. Actimab-A is ideally suited to be studied in combination with other therapeutic modalities like CLAG-M given its potency and minimal extramedullary toxicities. We are optimistic that this novel combination will demonstrate Actimab-A’ s key strengths through higher response rates, a greater number of patients successfully receiving a bone marrow transplant and ultimately, survival. Further, it will demonstrate the value of using Actimab-A in combinations as we believe that combination therapies will be the next wave in the treatment of patients with AML just as combinations of regimen’s approved in multiple myeloma over the past three or four years have become for patients with that disease."
Actinium will host a conference call on Tuesday, February 13, 2018 at 4:30 PM ET that will be led by Dr. Mark Berger, Actinium’s Chief Medical Officer and Dr. Atallah.
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Sandesh Seth, Actinium’s Chairman and CEO said, "This latest clinical initiative is especially exciting as it further demonstrates that we are building the industry leading CD33 Program. We the only company with multi-disease, multi-indication clinical trials with our ongoing Actimab-A, Actimab-M and planned Actimab-MDS studies and this latest initiative has the potential of extending the addressable patient population for Actimab-A. This is a viable approach for Actimab-A as we begin to strategize and implement the next phase of Actimab-A’s development. In doing so, we expect to maximize the value of our CD33 program and increase its synergies for potential partners and collaborators. Further, this initiative is aligned with Actinium’s core strategy of improving access and outcomes to transplants and one we are excited to embark on."
Actimab-A is Actinium’s lead drug candidate from its CD33 program and is an Antibody Radio-Conjugate (ARC) that is comprised of the CD33 targeting antibody lintuzumab and actinium-225, an alpha-emitting radioisotope. Actimab-A is currently being studied in Phase 2 clinical trial in patients that are newly diagnosed with AML who are over the age of 60 that are ineligible for intense chemotherapy, also known as unfit patients. The Company expects to complete patient enrollment of the Phase 2 trial in the first half of 2018 and report top line data results in the second half of 2018. The Company is also developing Actimab-M and Actimab-MDS, which are also CD33 actinium-225 ARCs. Actimab-M is being studied in a Phase 1 investigator-initiated trial for patients with refractory multiple myeloma. The Phase 1 Actimab-M trial is expected to complete enrollment and report top like data in the second half of 2018. Actimab-MDS is expected to begin a Phase 2 clinical trial in the second half of 2018 following a pre-IND meeting with the FDA in the first half of 2018. Actimab-MDS is intended to bridge patients with high-risk myelodysplastic syndrome (MDS) that have a p53 genetic mutation to a bone marrow transplant via targeted myeloablation.