Actinium Pharmaceuticals, Inc. has entered a collaboration with IsoTherapeutics Group to complete studies required for a new manufacturing process for Actimab-A, Actinium's Phase 1/2 trial for newly diagnosed acute myeloid leukemia (AML) patients in a single arm multicenter trial.
According to the companies, the newly developed manufacturing process results in a tenfold improvement of manufacturing yield. IsoTherapeutics will perform additional studies to generate the necessary documentation for regulatory submissions.
“Alpha particle immunotherapy is a new approach in oncology and for such novel technologies manufacturing development is inextricably linked with clinical development,” said Dr. Kaushik J. Dave, the president and chief executive officer of Actinium Pharmaceuticals. “We are encouraged by the big advancements we are making in both areas and confirmation of our methods from our partners and collaborators. These advances have application beyond any individual drug.”