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Clinical Trials

Date: 2012-10-23

Type of information:

phase: 3

Announcement: enrolment of the first patient

Company: Dompé (Italy)

Product: reparixin

Action mechanism: Reparixin is a potent selective chemokine interleukin-8 inhibitor developed by Dompè Italian R&D laboratories. Reparixin is an inhibitor of the CXCR1 receptor which in the body is activated by chemokine interleukin-8 that plays a key role in anti-inflammatory response. It is the first in a novel class of low-molecular weight inhibitors that can selectively modulate the receptor activity via an allosteric mechanism of action. An allosteric inhibitor can freeze the receptor in an inactive position binding it to a different site than the site taken by the natural ligand (IL-8).

Disease: prevention of graft rejection in pancreatic islet transplantation
type 1 diabetes

Therapeutic area: Metabolic diseases

Country: 7 countries in Europe, USA

Trial details: The randomized double-blind multicenter Phase III trial will be conducted in 10 centers of 7 countries in Europe and the United States on some 60 patients, i.e., half the total number of patients undergoing allogeneic pancreatic islet transplantation worldwide. The study will assess the efficacy of reparixin in improving the efficiency of pancreatic islet transplantation, but also its efficacy in increasing patient insulin independence and blood glucose control.

Latest news: Dompé, one of Italy’s leading biopharmaceutical companies, has announced the enrolment of the first patient into a Phase III trial on reparixin, a compound that has shown to improve the efficacy of transplantation of insulin-producing pancreatic islets, which is the new frontier in type 1 diabetes treatment.
In a randomized multicenter Phase II trial reparixin has shown to significantly improve the efficiency of pancreatic islet transplantation, preventing the death of beta-cells after transplantation, ensuring long term graft survival and thus increasing the percentage of patients who maintain insulin independence one year after the transplantation.

Is general: Yes