FDA clears Hansa Medical’s IND application for IdeS in kidney transplantation

Hansa Medical AB (publ) today announced that the US Food and Drug Administration (FDA) has completed the safety review of the company’s Investigational New Drug application (IND) and has concluded that the proposed clinical investigation can proceed. This enables Hansa Medical to start a clinical study to primarily evaluate IdeS’ efficacy in making highly sensitized kidney patients with positive crossmatches eligible for transplantation by removing donor specific antibodies. The clinical trial is scheduled to begin soon.The single arm study will include up to 20 kidney transplantation