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19 January 2010

Brussels - The JDRF Center for Beta Cell Therapy in Diabetes has announced the results of a four-year follow-up study of type 1 diabetic patients (age 12-39 years) who received, shortly after diagnosis, a six day course of antibodies against CD3 lymphocytes (ChAglyCD3). After the first 18 months, the Center has presented data showing that this antibody protected patients against further losses in their insulin-producing beta cells and hence in their insulin production. It now reports that this effect remained detectable during four-years but that it was predominantly present in the younger half of the studied patient population (12 to 26 years). Importantly, the younger antibody-treated subgroup not only needed lower daily insulin doses but also maintained a better glucose control than the age-matched placebo control. The observation that the lymphocyte antibodies suppressed the disease process more markedly in younger patients is related to its more acute progression in this age category. It is therefore suggested to extend the trials to children. This form of therapy is also proposed for testing in individuals at high risk for type 1 diabetes, where it may prevent progression to clinical onset.

These findings were reported this month in Diabetologia, the journal of the European Association for the Study of Diabetes. They result from a collaboration between clinical and laboratory researchers in Belgium, France, Germany and the United Kingdom (see list below). The Belgian Diabetes Registry collected and analyzed blood samples and centralized data. This academic study was made possible through a grant by the Juvenile Diabetes Research Foundation (New York).

"Our data represent a step towards treatment of type 1 diabetes at an early stage, and possibly towards its prevention" says Dr Pipeleers, director of the JDRF Center, "It will now be necessary to define efficacious and safe protocols for antibody administration in recent-onset type 1 diabetic patients including children, as well as in individuals at high risk for this disease. The ability to protect type 1 diabetic patients against further losses of insulin-producing beta cells also sets the stage for a second clinical aim, the replacement of the lost beta cell mass."

Paper published online in Diabetologia (www.diabetologia-journal.org)

About type 1 diabetes

Diabetes is a frequent chronic disease, which reduces quality of life and increases risks for serious complications, despite current treatment. When diagnosed before the age of 40 years, it usually represents the type 1 form, which is caused by a massive loss of insulin-producing beta cells following an inflammatory- and immune-mediated process. In an early phase of this form, therapeutic strategies aim for a protection of residual beta cells against further losses and for a replacement of the lost beta cells, preferentially by regeneration in the pancreas. In patients with a long-standing depletion of beta cells, beta cell replacement by transplantation is proposed as therapy.

About CD3-antibodies

CD3 antibodies, such as the ChAglyCD3 used in this study, have been developed to suppress the activity of CD3-cells, which are a subgroup of T-lymphocytes, that are involved in the immune -mediated destruction of pancreatic beta. ChAglyCD3 is a humanized, non-mitogenic CD-3 antibody, developed and produced for this study by Drs. Herman Waldmann and Geoff Hale (Oxford, United Kingdom). It is currently under pharmaceutical development -under the name of Otelixizumab- by Tolerx-Inc (USA) and GlaxoSmithKline (UK).

About the JDRF Center for Beta Cell Therapy in Diabetes

The JDRF Center for Beta Cell Therapy in Diabetes is an international consortium of laboratory and clinical research teams, reference centers and bio-industrial partners, with central unit on the medical campus of Brussel Free University-VUB. The objective of the Center is to develop and implement strategies for prevention and treatment of diabetes using beta cell biology as guide. Projects specifically focus on methods to preserve and replace beta cells, and to monitor effects in vivo. They have received support by Center grants from the Juvenile Diabetes Research Foundation and the European Commission (FP6 and FP7).

The following institutions and individuals have contributed to the reported observations:

Belgium

  • Vrije Universiteit Brussel en Universitair Ziekenhuis Brussel: Bart Keymeulen, Leonard Kaufman, Robert Hilbrands, Frans Gorus, Evy Vandemeulebroucke, Ursule Van de Velde, Daniel Pipeleers
  • Universitair Ziekenhuis Gasthuisberg, Katholieke Universiteit Leuven: Chantal Mathieu
  • Universitair Ziekenhuis Antwerpen: Christophe De Block
  • Hôpital Erasme, Université Libre de Bruxelles: Laurent Crenier
  • Belgian Diabetes Registry: network of diabetologists, pediatricians and researchers in more than 100 institutions in Belgium.

France

  • INSERM U580, Hôpital Necker, Paris: Sophie Candon, Lucienne Chatenoud

Germany

  • Hospitaal München-Schwabing: Markus Walter, Anette G. Ziegler

United Kingdom

  • Sir William Dunn School of Pathology, Oxford: Herman Waldmann

Contact

Christel Hendrieckx
Coordination Manager JDRF Center for Beta Cell Therapy in Diabetes
32-2-477 4559 or 32-2-477 4501
c.hendrieckx@betacelltherapy.org