Dompe Launches Transplantation Trial

Dompé has launched REP0112, a Phase II/III trial to assess the efficacy and safety of Reparixin in autologous islet cell transplantation, a procedure where pancreatic cells are taken from the patient’s own pancreas and surgically removed for a pancreatic pathology. Enrollment of the first patient is scheduled by the end of 2013 and results are expected in early 2016.

REP0112 will enroll 100 islet transplantation-naïve adult patients with iatrogenic diabetes who have undergone total pancreatectomy (total pancreas removal) and are candidates for intrahepatic islet cell transplantation. The patients will be randomized into two groups to receive either Reparixin administered by continuous intravenous infusion for seven days or placebo. The primary objective of the trial is to assess whether Reparixin contributes to improve islet cell transplantation outcomes by measuring the percentage of patients who attain insulin independence after the procedure. The trial will also assess specific treatment safety parameters.

Results from a Phase II trial on patients who have undergone islet cell transplantation from donors and in association with immunosuppressive drugs show that treatment with Reparixin promotes graft function after allogeneic transplantation, results in a significant improvement of the blood glucose control compared to the pre-transplant condition, and delivers insulin independence in three out of four patients.