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Isis Reports Phase 2 Data on ISIS-APOCIII Rx Showing Substantial Reductions of Triglycerides and Apoc-III in Patients with Familial Chylomicronemia
Date:9/21/2013

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"Our focus is to bring ISIS-APOCIIIRx to the market for patients with severely elevated triglycerides.  These patients cannot reduce their triglycerides to safe levels with currently available medicines. We are extremely pleased with the performance of ISIS-APOCIIIRx to date. These data presented today are particularly encouraging as we plan to pursue FCS as the initial indication for ISIS-APOCIIIRx in advance of our next indication in patients with severely elevated triglycerides. We believe that the significant unmet medical need for an effective triglyceride-lowering drug for patients with FCS and the robust, consistent effects we observe with ISIS-APOCIIIRx should enable us to rapidly move forward," said Richard Geary, Ph.D., senior vice president of development at Isis.  "We look forward to discussing our Phase 3 plans with regulators and moving into a Phase 3 program next year in both patients with FCS and patients with severely high triglycerides."

FCS is a rare genetic disorder that affects approximately one to two out of a million people.  The most common genetic cause of FCS is a defect in the lipoprotein lipase (LPL) gene, which results in extremely low levels of LPL activity and a significant reduction in the breakdown of triglycerides from the blood.  In the study reported today, all three patients had the same genetic defect (P207L mutation) resulting in undetectable LPL activity.

ISIS-APOCIIIRx is an antisense drug being developed for the treatment of treat patients with severely high triglycerides either as a single agent or in combination with other triglyceride-lowering agents.  ISIS-APOCIIIRx targets apoC-III, a protein produced by the liver that plays a central role in the regulation of serum triglycerides.  This approach is validated by the fact that humans who produce low levels of apoC-III have
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SOURCE Isis Pharmaceuticals, Inc.
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