Actinium Pharmaceuticals ( NYSE: ATNM ) announced Thursday that the U.S. FDA greenlighted an Investigational New Drug (IND) filed to request its clearance to conduct a clinical trial for the company's radiopharma candidate Iomab-ACT.
ATNM’s IND filing aimed to advance Iomab-ACT as a conditioning agent before bone marrow transplant in patients with sickle cell disease. The company will collaborate with Columbia University to conduct the study, which is expected to form the basis for another clinical trial designed to evaluate Iomab-ACT as a targeted conditioning agent before gene therapy. Late last year, the FDA approved two gene therapies for sickle cell disease: Lyfgenia, developed by bluebird bio ( BLUE ), and Casgevy, developed by Vertex Pharmaceuticals ( VRTX ) and CRISPR Therapeutics ( CRSP ).
“Success in this trial could revolutionize treatment, enabling the use of a low-toxicity method for the engraftment of genetically engineered autologous stem cells in SCD patients,” said Markus Mapara, a Professor of Medicine at Columbia University, who leads the trial..
