Subject: News from ALSA: Drug Development Update

Celebrex at 800 mg per day shows no benefit in study of people with ALS

October 26, 2004

The initial analysis of data from the 12-month study of Celebrex failed to show a benefit for people with ALS. Although more analysis of additional study data is continuing, the Northeast ALS Consortium investigators are releasing this key finding to provide timely information to patients.

There were no side effects or adverse events from the 800 mg. per day
dose.

More detailed information will be released when the full data analysis is complete.

The clinical trial of Celebrex included 300 patients at 25 sites across the country. It was a placebo-controlled, double blind study that had hoped to demonstrate a slower rate of progression in ALS.

Celebrex has been shown to inhibit COX-2, thereby blocking
prostaglandin and is thought to lead to the inhibition of glutamate release from astrocytes and free radical production.

The ALS Association
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