Roche Diagnostics’ products help in the success of ITN multicentre trial.
As one of the few ways to develop a cure for Type 1 diabetes, progress reported by the Immune Tolerance Network (ITN) is of interest as it shows promise for treating people with unstable diabetes and may be effective in protecting them against more serious complications arising from the disease.
The Immune Tolerance Network (ITN) is a collaborative scientific and research organisation, which aims to accelerate the clinical development of new tolerance therapeutics in human disease. ITN has now released preliminary results from its 36-patient multicentre clinical trial of the Edmonton Protocol for human islet transplantation. This trial is for people with unstable, Type 1 diabetes.
Success in human islet transplantation may lead to improvements in other curative, cell-based approaches, such as xenotransplantation or stem cell therapy, which could treat a larger number of people with diabetes.
Roche Diagnostics has been taking part in the trial as the manufacturer of Roche’s Liberase™ HI Enzyme, a purified collagenase preparation specifically developed for isolating human islets for transplantation.
Dr. James Shapiro, Director of the Clinical Islet Transplant Program in Edmonton, Alberta, Canada, and Principal Investigator of the ITN Multicentre Islet Transplant Trial, reported:
"These are exciting times in islet transplantation, as this therapy moves one large step forward from research to standard practice of medicine. In its current form, islet transplant will only be suitable for highly selected patients with the most brittle forms of type 1 diabetes. As the treatment develops, however, we anticipate the day that it will be more widely available to a larger population of diabetes sufferers."
"The early results of the international multicentre trial have shown us that the Edmonton Protocol and more recent protocol variants can work extremely well and provide us with much of the knowledge required for more widespread implementation of the technique."
"Roche Diagnostics has been integral to the success of this remarkable therapy. The development of low endotoxin, standardized lots of Liberase enzyme has made one of the biggest differences to our ability to transplant islets. Before this enzyme, we had far less success at making islets."
"Roche is to be congratulated in facilitating the transition from art to science in the islet extraction process. Their willingness to work so closely with multiple investigators worldwide, and to continually refine their product to meet individualized specifications is a huge tribute to their team spirit and determination to support islet transplantation."
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.
Apart from developing the Liberase HI enzyme, Roche Pharmaceuticals’ immunosuppresive product Zenapax® (daclizumab) indicated in the prophylaxis of acute organ rejection in patients receiving kidney transplants, has been used in the ITN trial.
About Zenapax
Zenapax is an immunosuppressive humanized monoclonal antibody or "anti-rejection" drug, which was approved by the FDA in December 1997 for use in combination with other immunosuppressive agents (cyclosporine and corticosteroids) to prevent acute organ rejection in kidney transplant patients.
Keywords : Immune Tolerance Network ITN Roche Diagnostics Human pancreatic islet cell transplantation Edmonton protocol Canada Multicentre trial Unstable Type 1 diabetes Complications Liberase HI collagenase Zenapax immunosuppressive monoclonal antibody
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