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

ed moment," said R. Rodney Howell, M.D., Chairman of the MDA Board of Directors. "More than 30 people with familial ALS caused by mutations in the SOD1 gene soon will receive infusions of a SOD1 inhibitor directly into their central nervous systems."  Dr. Howell added that "MDA has invested more than $270 million fighting ALS, and it's exciting to see an excellent dose-escalation study get underway to assess the safety of ISIS-SOD1Rx."

ABOUT ISIS-SOD1Rx

ISIS-SOD1Rx is designed to inhibit the production of SOD1.  In preclinical studies, Isis, in collaboration with Timothy Miller, Don Cleveland (University of California, San Diego), and Richard Smith (Center for Neurological Study) were able to lower production of SOD1 with ISIS-SOD1Rx in neurons and surrounding cells and prolong life in rats that showed many symptoms of ALS.  In December 2007, the FDA granted ISIS-SOD1Rx Orphan Drug designation for the treatment of ALS. Because antisense drugs do not cross the blood-brain barrier, a small pump administers the drug directly into the central nervous system infusing the drug into the cerebral spinal fluid. Clinicians call this type of administration intrathecal infusion.  As part of Isis' alliance with Genzyme, Genzyme has a right of first negotiation to license ISIS-SOD1Rx from Isis.


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SOURCE Isis Pharmaceuticals, Inc.
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