From Medical News Today // June 27, 2005
The Juvenile Diabetes Research Foundation (JDRF), the world's leading charitable funder of research into type 1 diabetes and its complications, announced today that JDRF-funded researchers in Europe have shown that short-term treatment with an anti-CD3 antibody (ChAglyCD3) can preserve residual beta cell function and decreases the insulin need for at least 18 months in people with recent-onset type 1 diabetes. This finding, reported in the June 23 issue of the New England Journal of Medicine, represents an important step towards finding ways to prevent and stop type 1 diabetes by altering the clinical course of the disease.
The Phase II clinical trial involved 80 newly diagnosed patients, was conducted in collaboration with a team of clinicians and researchers from France, Belgium, Germany and England* and was led by Lucienne Chatenoud, M.D., Ph.D. of the Hopital Necker in Paris. Dr. Bart Keymeulen (in Brussels) was the clinical coordinator for the trial, which was one of the projects undertaken by the JDRF Center for Beta Cell Therapy in Europe, directed by Daniel Pipeleers, M.D., Ph.D.
The team found that patients who received the antibody over the course of six days immediately following their diagnosis continued to produce their own insulin and needed less supplemental insulin to maintain normal blood glucose levels, as compared with patients who received a placebo. This benefit was apparent at 6, 12 and 18 months after the treatment, suggesting that the protective effect is lasting -- although for how long is not yet known. Moreover, side effects were minor and short-lived including flu and mono-like symptoms.
"These exciting results provide enormous hope that we can preserve residual beta cell function by modulating the autoimmune attack and in fact change the clinical course of type 1 diabetes," said JDRF Executive Vice President for Research Richard Insel, M.D. "There is no other current treatment that can actually change the clinical course once the disease has begun. This study shows we are on the right track, and opens the door for researchers to target this treatment specifically to individuals who would receive the most benefit."
This clinical trial extends a JDRF study using a similar antibody -- published in 2002 -- by Kevan Herold, M.D., of Columbia University College of Physicians and Surgeons, and Jeffrey Bluestone, Ph.D., director of the JDRF Center for Islet Transplantation at University of California, San Francisco/University of Minnesota.
The European study takes the Bluestone/Herold study -- and anti-CD3 research overall -- a step further by involving a much larger group of patients and recording how much residual beta cell function each patient had at the beginning of treatment. This allowed the researchers to track and compare ChAglyCD3's effect on patients who had high and low residual beta cell function initially to see how well the drug worked with patients in both categories. The research team observed that ChAglyCD3's protective effect was more pronounced in patients who had higher beta cell function at the time they received the drug. Interventions that can preserve endogenous insulin production are expected to result in better metabolic control of diabetes, and thus delay, or reduce the risk of diabetes-related complications such as eye, nerve and kidney disease.
As stated by Dr. Chatenoud, "A tremendous amount of work was put into this study, and I am thrilled with the outcome. The team of clinicians and their colleagues who dedicated themselves to this effort are to be commended for their work. These include Dr. Bart Keymeulen and Dr. Chantal Mathieu in Belgium and Dr. Anette Ziegler in Germany, as well as the Belgian Diabetes Registry, all of whom made it possible to recruit the patients. And I would be remiss for not mentioning that the international collaboration within the JDRF Center allowed the researchers to proceed in an efficient manner."
"JDRF made this possible" said Dr. Pipeleers. "We can now inform patients that a step has been made towards stopping the disease but we will also have to explain why more work is needed before a treatment will be routinely available for clinical practice."
About Anti-CD3
Anti-CD3 antibodies such as ChAglyCD3 and hOKT3g1 (ala-ala) are engineered to block the function of CD3 cells, immune T cells that orchestrate the destruction of islets. The antibodies prevent "activation" of the T cells after they have identified their target, disarming them once they are poised to attack.
The ChAglyCD3 drug that was used in the European study is a humanized, non-mitogenic anti-CD3 antibody, a new type of agent showing promise for this kind of intervention. This antibody was conceived and manufactured by Drs. Herman Waldman and Geoff Hale in Oxford, England.
About JDRF
JDRF (http://www.jdrf.org) was founded in 1970 by the parents of children with juvenile diabetes -- a disease that strikes children suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $800 million to diabetes research worldwide. More than 80 percent of JDRF' expenditures directly support research and education about research. JDRF's mission is constant: to find a cure for diabetes and its complications through the support of research.
-- The coauthors are: Bart Keymeulen, Evy Vandemeulebroucke, Frans Gorus, Pieter De Pauw, Denis Pierard, Ilse Weets, Daniel Pipeleers from the VUB-Academic Hospital and Brussels Free University-VUB in Brussels, Belgium; Chantal Mathieu from the UZ Gasthuisberg, Katholieke Universiteit Leuven -- KUL in Leuven, Belgium; Christophe De Block from the University Hospital Antwerp-UIA in Antwerp, Belgium; Michel Goldman, Liliane Schandene and Laurent Crenier from Hopital Erasme, Universite Libre de Bruxelles -- ULB in Brussels, Belgium; Anette Ziegler and Markus Walter from the Hospital Munchen-Schwabing in Munich, Germany; Leonard Kaufman, from Brussels Free University-VUB in Brussels, Belgium; Geoff Hale, Pru Bird, Eleanor Berrie, Mark Frewin, and Herman Waldmann, from the Sir William Dunn School of Pathology in Oxford, England; Lucienne Chatenoud, Sophie Candon and Jean-Francois Bach from Hopital Necker-Enfants Malades, INSERM U580 in Paris, France and Jean-Marie Seigneurin from the CHU Michallon in Grenoble, France. The Belgian Diabetes Registry includes over 200 diabetologists, pediatricians and researchers from all Belgian universities and over 100 non-university hospitals.
The Juvenile Diabetes Research Foundation; New England Journal of Medicine
http://www.jdrf.org
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