The Immune Tolerance Network (ITN), a collaborative scientific and research organization aiming to accelerate the clinical development of new tolerance therapeutics in human disease, announced preliminary results from its 36-patient multicenter clinical trial of the Edmonton Protocol for human islet transplantation. This trial targets people with unstable Type 1 diabetes. Roche Diagnostics participated in the trial through the manufacture of Roche's Liberase HI Enzyme, a purified collagenase preparation that was specifically developed for the isolation of human islets for transplantation.

Human islet transplantation is one of the few curative approaches to Type I diabetes under development today. Recent success suggests that it may be an effective treatment for persons with unstable diabetes and protect against the serious secondary complications associated with the disease. It is expected that success in human islet transplantation will lead to improvements in other curative, cell-based approaches, such as xenotransplantation and stem cell therapy, which could treat a larger number of persons with diabetes.

For nearly 20 years, Roche Diagnostics has been involved in the development and manufacturing of purified enzymes for human islet isolation. Roche researchers were trained in islet isolation at several of the clinical centers that participate in the ITN study, and developed the Liberase HI enzyme as a result of that training.

Roche Pharmaceuticals' Zenapax (daclizumab), an immunosuppressive medication indicated in the prophylaxis of acute organ rejection in patients receiving kidney transplants, also was used in the ITN trial.

"Roche Diagnostics enthusiastically supports this trial and applauds its encouraging results. We are proud to have played an important role in the development of Liberase enzyme, a critical reagent in this groundbreaking trial. Our participation in these clinical trials is further evidence of our commitment to diabetes care and the vision we have for continuous monitoring and an automated pancreas," said Martin Madaus, President and CEO, Roche Diagnostics Corporation, North America. "Whether it's an Accu-Chek blood glucose monitor which helps those living with diabetes manage their disease more easily, or a purified enzyme that helps make islet transplantation a clinical reality, Roche is dedicated to working with the ITN and others to push the limits in finding the best approaches to treat or cure diabetes."