Actinium Pharmaceuticals has applied an Investigational New Drug for Actimab-A combined with CLAG-M, for Acute Myeloid Leukemia, to the USFDA.
The NYSE listed company plans to study the combination in the first phase at the Medical College of Wisconsin, lead by doctors Ehab Atallan and Sameem Abedin. It will be a dose escalation study
Sandesh Seth, Actinium’s Chairman and CEO said CD33 targeting ARC or Antibody Radio-Conjugate have enabled the expansion of the company’s CD33 Program from a single indication to the only multi-disease program in the industry.
“In addition to the Actimab-A trial in newly diagnosed older AML, we have the only CD33 targeting agent in multiple myeloma via the Actimab-M trial. We are also exploring its use in targeted myeloablation in high-risk MDS with Dr. Roboz and the MDS Clinical Research Consortium via the planned Actimab-MDS trial,” Seth has said in a press release.
Chance to maximize value for partners and collaborators
Seth sees the chance to maximize the value of the program to a great number of potential partners and collaborators. “Our intent is to further improve our positioning as the best in class CD33 program with applications as a therapeutic, myeloablative agent, and also the synergistic value of adding internalized radiation as a therapeutic modality to chemotherapy and other treatment approaches,” Seth said.
CLAG-M, a salvage chemotherapy regimen consisting of cladribine, cytarabine, and filgrastim, with mitoxantrone, is designed to induce remission in AML patients who are refractory to or have relapsed after standard induction therapy.
Dr. Mark Berger, Actinium’s Chief Medical Officer said that CLAG-M has become a widely used regimen for patients that is the standard of care at many institutions across the U.S. based on its ability to produce remissions in patients in relapse.
He further explained that, by utilizing Actimab-A with CLAG-M, Actimab-A should increase potency and minimal extramedullary toxicities should derive synergies when used in combination with other active AML drugs. “This important Phase 1 study will assess safety of the combination and determine an appropriate dose level for future studies,” Berger said. According to Actiniums chief medical officer, this combination could increase remission rates in relapsed patients in future studies. It is also expected that the Actimab-A CLAG-M could be used in combination regimen to increase the rate of successful stem cell transplant in relapsed patients, via improved myeloablation with the combination regimen.