Hansa Medical announces 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 patients that have either failed on previous attempts of desensitization or in whom effective desensitization using currently available methods is highly unlikely. The trial is scheduled to begin soon at reputable medical institutions in the US, with the aim to complete recruitment during the first half of 2017.
“Following the encouraging results in the on-going trials conducted by Professor Gunnar Tufveson at Uppsala University Hospital and Professor Stanley Jordan at Cedars-Sinai Medical Center, respectively, we are excited to begin this US trial with Hansa Medical as sponsor, investigating IdeS in highly sensitized patients”, said Göran Arvidson, President and CEO of Hansa Medical AB. “FDA clearance of the IdeS IND is a milestone for the company defining a potential path toward product approval.”
The first trial to be conducted under this IND is titled “A Phase II Study to Evaluate the Efficacy of IdeS (IgG endopeptidase) to Desensitize Transplant Patients with a Positive Crossmatch Test”. The primary objective is to assess IdeS’ efficacy in creating a negative crossmatch test. The trial will also evaluate the safety, kidney function and immunogenicity during the 6-month follow-up period.