Further testing and development of the new therapy is planned in a multi-center clinical trial of more than 80 patients to be conducted by the international Immune Tolerance Network (ITN), funded by the NIAID, NIDDK, and the JDRF. The ITN aims to accelerate clinical trials of innovative immune therapies in autoimmune diseases, allergy and transplantation. The expanded study will evaluate a multiple dose regimen designed to amplify the effects of the drug, in a fashion analogous to the repeated administration of vaccines.
The results of the trial published in the NEJM establish the effectiveness of managing early state Type 1 diabetes and possibly other immune diseases with the drug administered over the short-term to provide benefits over the long-term, the researchers say. Ultimately, they say, the best way to deal with diabetes will be to prevent the disease entirely or to restore insulin-secretion in Type 1 diabetics through islet transplantation.
The ITN already is investigating hOKT3g1 (ala-ala) in clinical trials of islet transplantation for Type 1 diabetes and for treatment of psoriatic arthritis, a type of arthritis that develops in about a quarter of people who have psoriasis.
Co-authors on the paper and colleagues in the research are William Hagopian, M.D., Ph.D., Pacific Northwest Research Institute, Seattle; Julie A. Auger, University of Chicago; Ena Poumian-Ruiz and Lesley Taylor, Naomi Berrie Diabetes Center, Columbia University College of Physicians & Surgeons; David Donaldson, M.D., University of Utah, Salt Lake City; Stephen E. Gitelman, M.D., University of California at San Francisco; David M. Harlan, M.D., National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md.; Danlin Xu, Ph.D., and Robert A. Zivin, Ph.D., R. W. Johnson Pharmaceutical Research Institute, Raritan, N.J.
NOTES The new drug offers significant advantages in several important ways:
It is humanized
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Contact: Annie Bayne
as862@columbia.edu
212-305-3900
Columbia University Medical Center
29-May-2002