Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that a study presented at the American Academy of Neurology this month of 239 relapsing-remitting multiple sclerosis (MS) patients receiving Copaxone showed sustained reductions in disease activity and disease burden as measured by magnetic resonance imaging (MRI). Patients switching from placebo to Copaxone therapy decreased the total mean number of enhancing lesions from 12.6 to 5.9, a reduction of 53% (p<0.0001). In patients treated with Copaxone from the beginning of the 18-month trial, the mean total number of enhancing lesions showed a further, although minor, reduction from 7.7 to 6.2, by 20%.
The mean volume of enhancing lesions had the same characteristics. The volume fell by 56% in the group initially randomized to placebo and switched to active therapy after 9 months (p<0.0001), and it fell by a further 27% in the patients who began the study on Copaxone.
"The results indicate that the effects of glatiramer acetate on MRI measures of the pathology of the disease found during the placebo-controlled phase of the trial were sustained in the group always on glatiramer acetate and replicated in the placebo group on beginning treatment," said Jerry S. Wolinsky, M.D., director of the MS Research Group at the University of Texas-Health Science Center.
This study was a nine-month extension of a European-Canadian trial that evaluated people with relapsing-remitting MS using MRI brain scans. In the original nine-month, double-blind, placebo-controlled phase, patients underwent monthly MRI brain scans. The patients were randomized to either Copaxone (glatiramer acetate for injection) or placebo. Then, researchers evaluated the scans to determine the number and volume of brain lesions in each group.
In the extension phase, all study participants received Copaxone and MRI scans every three months. The total number of enhancing lesions was the primary endpoint.
Copaxone is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis. It reduced relapse rates by a mean of 29% in a 24-month study (1.19 vs. 1.68 for placebo, p=0.055).
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. Be sure to tell your 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.
Teva Pharmaceutical Industries, Ltd. was granted approval by the U.S. Food and Drug Administration (FDA) in December 1996, to market Copaxone. The drug was launched in April 1997.
Published by Israel's
Business Arena on May 10, 2001.