Copaxone Shown to Reduce "Black Holes" in Brain
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Copaxone Shown to Reduce "Black Holes" in Brain

KANSAS CITY, MO -- October 10, 2001 -- A study published in the August issue of Neurology showed that Copaxone® (glatiramer acetate for injection) reduced by 50 percent the percentage of permanent "black holes" that developed in patients with relapsing-remitting multiple sclerosis. Black holes are lesions MS can cause in the brain, and these lesions, if permanent, represent areas where the most severe and irreversible brain tissue damage has occurred.

"This study was designed to determine if glatiramer acetate could modify the severity of tissue damage in the lesions of MS patients. We know that permanent black holes represent areas with most severe brain damage. The study showed that the drug has the potential to prevent some of the delayed tissue destruction that can follow newly enhanced lesions," said Jerry S. Wolinsky, M.D., director of the MS Research Group at the University of Texas-Health Science Center.

The study evaluated 1,722 new lesions from 239 (119 glatiramer acetate, 120 placebo) MS patients enrolled in the placebo-controlled MRI trial with Copaxone. Investigators monitored these patients with monthly cerebral MRI scans. These scans measured the numbers and sizes of several types of lesions in the brain.

On subsequent monthly scans, researchers evaluated serial changes in tissues that follow the formation of new enhanced lesions. "The percentage of black holes on the follow-up scans was lower in Copaxone-treated patients than in placebo after seven months of follow up", concluded Massimo Filippi, M.D., Head of the Neuroimaging Research Unit, Department of Neuroscience, Scientific Institute and the University Ospedale San Raffaele, Milan, Italy. At month seven, the percentage of lesions that persisted as black holes was 18.9 percent for patients treated with Copaxone (glatiramer acetate for injection) and 26.3 percent for placebo, p equals 0.04. At month eight, the percentage was 15.6 percent for Copaxone-treated patients and 31.4 percent for placebo, p equals 0.002.

Copaxone is indicated for the reduction of relapses in relapsing- remitting MS. The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Patients should tell their doctor about any side effects.

Some patients report a short-term reaction right after injecting Copaxone. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

Source: Teva Neuroscience

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