Idogen AB (publ) received approval from the Norwegian Medicines Agency, NoMA, to ben recruitment for its clininical phase 1/2a study with IDO 8, a completely new type of cell therapy for patients with severe hemophilia A who have developed antibodies to their treatment with coagulation factor VIII. The Swedish Medical Product Agency has already previously approved the phase 1/2a study and patient recruitment in Sweden will begin as soon as the authority has formally approved the local trial center where the study is to be carried out. The approval from NoMA now gives the go -ahead to start patient recruitment in Norway as well.

The plan is for the study to be carried out in several European countries. Idogen's cell therapy IDO 8 is tailored for each individual patient in a GMP-certified facility at the company's Dutch manufacturing partner Radboud University Medical Center (RUMC). The study has been designed in dialogue with the regulatory authorities in the Nordic countries and the goal is to evaluate the safety of IDO 8 and to follow signals of treatment effect in patients.