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ISIS Initiates Phase 1 Clinical Trial of ISIS-SOD1Rx in Patients With ALS
Date:3/5/2010

in demonstrating the applicability of antisense drugs to treat severe neurodegenerative diseases.  We also continue to advance our earlier-stage programs toward human studies."  

The Phase 1 study of ISIS-SOD1Rx is a placebo-controlled, dose-escalation study designed to assess the safety, tolerability and pharmacokinetic profile of ISIS-SOD1Rx in patients with familial ALS that is caused by mutations within the SOD1 gene.  The study consists of four cohorts with eight patients each.  In this study, ISIS-SOD1Rx will be administered intrathecally using an external pump to deliver the drug directly into the spinal fluid during a single, 12-hour infusion.  The study will be conducted in multiple centers within the United States.  

"This therapy will be the first treatment for ALS that is specifically aimed at the target, SOD1, known to cause ALS. The development of new treatments for ALS is an extremely challenging and costly process.  The ALS Association has been pleased to co-fund this study and partner with Isis on this extremely promising treatment approach. It is only through the support of our generous donors that this type of advancement is made possible," commented Lucie Bruijn, Ph.D., Chief Scientist, The ALS Association.

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SOURCE Isis Pharmaceuticals, Inc.
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