Actinium Pharmaceuticals is to initiate a Phase ll trial of Actimab-MDS for the treatment of myelodysplastic syndrome (MDS) next year.
The proposed trial is also aimed at studying Actimab-MDS as a conditioning regimen for patients with MDS and p53 genetic mutations who will undergo a bone marrow transplant.
During the trial, patients will receive 4.0µCi/kg administered through a single infusion 12 days prior to receiving their bone marrow transplant.
Actimab-MDS is a part of Actinium’s new clinical initiative under the company’s CD33-Alpha programme, which combines the CD33 targeting ability of lintuzumab antibody with the cell-killing power of the alpha-particle-emitting radioisotope Actinium-225.
It is based on Actinium’s clinical development experience conducted on more than 100 patients and various clinical trials with Actimab-A in patients with acute myeloid leukemia (AML) and Actimab-M in patients with multiple myeloma (MM).
Weill Cornell New-York Presbyterian Hospital Medicine professor and leukemia programme director Dr Gail Roboz will be the principal investigator for the trial, which will see the participation of MDS Clinical Research Consortium.
Actinium chairman and CEO Sandesh Seth said: “Actimab-MDS aligns perfectly with Actinium’s strengths as we have significant expertise and know in the area of bone marrow transplant as a result of our experience with our pivotal Phase lll programme, Iomab-B.
“Looking forward, we believe there exists for Actinium a compelling revenue opportunity in the 2020-2021 timeframe by launching not one but possibly two therapies that can provide safer myeloablation with the potential for increasing curative outcomes from bone marrow transplant.”
MDS is currently estimated to be prevalent in 60,000 patients in the US and 40,000 patients in the EU.