The Italian biopharmaceutical company Dompé today announced the launch of REP0112, a randomized double-blind multicenter Phase II/III trial to assess the efficacy and safety of Reparixin in autologous islet cell transplantation, a procedure where, unlike the transplantation from a donor, pancreatic cells are taken from the patient´s own pancreas surgically removed for a pancreatic pathology. Enrolment of the first patient is scheduled by the end of 2013 and results are expected in early 2016.
The REP0112 trial will enroll 100 islet transplantation-naïve adultpatients 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.
Reparixin acts directly on the body’s anti-inflammatory response that develops in the very first days after autologous islet cell transplantation, notably the anti-inflammatory response of specific white blood cells, known as polymorphonuclear leukocytes. As CXCL8 or interleukin-8 plays a key role in the anti-inflammatory response triggered right after the pancreatic cell infusion, it is a key target in drug development to prevent such response and facilitate successful implantation. Reparixin acts on CXCL8 and in both in vitro and in animal models it has shown to improve graft survival rates and graft function thanks to its protective action.
The results from a Phase II trial on patients who have undergone islet cell transplantation from donors and in association with immunosuppressive drugs – that were also presented at IPITA 2013 – 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 3 out of 4 patients.
“The trial that is about to start in the US complements and rounds out the Phase III trial that is underway in Europe to assess the efficacy and safety of Reparixin in allogeneic islet cell transplantation and involves about half of those who undergo this procedure annually” – explains Prof. Lorenzo Piemonti, Deputy Director of the San Raffaele Diabetes Research Institute and Director of the Islet Cell Transplantation Program – “The patient’s anti-inflammatory response in the days following islet infusion adversely impacts cell survival with a 50% decline in islet function in the first 7 days after the procedure. Reparixin is being investigated to assess its inflammatory response inhibiting action and its contribution to improve the efficacy of islet cell transplantation and insulin independence.”
“Dompé is committed to identifying treatment solutions for rare, often orphan, diseases. For this reason we are particularly proud of the launch of this Phase II/III trial in the US, a step that brings us closer to providing patients with another effective and safe treatment that satisfies medical needs that are still unmet – said Eugenio Aringhieri, CEO, Dompé – “The trial we are announcing today and Reparixin, one of the drugs developed by our company, produced at our bio-technology sites and supplied globally, are a testament to our commitment in the industry. This also marks a milestone in our expansion into the US, a country where we recently established a Group subsidiary.”
