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Small trial shows daclizumab add-on therapy improves MS outcome

rating scale and in a test of hand function. The clinical improvement was unexpected in such a small trial, since a larger number of patients is usually required to show clinical effects. One patient with extremely high inflammation activity responded initially to daclizumab but, as disease activity returned, was given higher doses of the antibody and was excluded from final analysis.

"There is great interest now in new approaches and new therapies for a disorder about which we know too little and have only moderately effective therapies," said Dr. Martin. "The combined therapy was well tolerated by all patients, with side effects that were either mild or clearly not caused by daclizumab." He said the therapy limits the activity of T-cells that attack the myelin coating around the nerves, without shutting down the entire immune system.

"While these results are preliminary, this discovery offers hope for thousands of patients with certain forms of MS. Findings like this are helping us to better understand how this disease affects the immune system, which offers hope for all MS patients," said Story C. Landis, Ph.D., NINDS director.

Further studies are needed to confirm the extent of the clinical benefit of daclizumab on typical MS patients and determine whether daclizumab is effective as a stand-alone therapy.

The study was a collaboration between the NINDS and its sister agency, the National Cancer Institute (NCI). Thomas Waldmann, M.D., chief of the metabolism branch for NCI's Center for Cancer Research, developed the antibody used in the trial.

Daclizumab (trade name Zenapax) received FDA approval in 1997 for use in kidney transplantation.


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Contact: Paul Girolami
301-496-5751
NIH/National Institute of Neurological Disorders and Stroke
24-May-2004


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