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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

problems.  More effective triglyceride-lowering approaches are needed to treat FCS patients," said Daniel Gaudet, M.D., Ph.D., from the department of medicine, University of Montreal and scientific director, Genome Quebec Biobank Technology Center.  "ISIS-APOCIIIRx has been shown to be a robust triglyceride-lowering agent in patients with moderately high to severely high triglycerides in multiple Phase 2 settings.  These data presented today, although collected in a small number of patients, are also compelling and demonstrate the potential of ISIS-APOCIIIRx to produce dramatic  triglyceride lowering in patients with FCS.  Based on the comprehensive Phase 2 data for ISIS-APOCIIIRx, I am extremely encouraged about the therapeutic potential for ISIS-APOCIIIRx in patients with severely high triglycerides, especially for use in FCS patients who have very limited therapeutic options."

The Phase 2 open-label cohort was designed to assess the safety and activity of ISIS-APOCIIIRx in patients with severely high triglyceride levels (greater than 440 mg/dL) and a genetic confirmation of FCS.  The data reported today is an analysis of the three FCS patients in the study all of whom had baseline triglyceride levels greater than 1,400 mg/dL and had completed 13 weeks of treatment with 300 mg of ISIS-APOCIIIRx.  In this study, all three patients treated with ISIS-APOCIIIRx achieved substantial reductions in triglyceride levels with an average reduction of 69 percent.  In addition, these patients experienced positive effects on other lipid parameters, including HDL-C, apoC-III and apoC-III-associated VLDL-C.  Because FCS is an extremely rare genetic disorder affecting one to two people per million, clinical trials in this disease are generally quite small.

Table 1:  ISIS-APOCIIIRx Produced Substantial
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SOURCE Isis Pharmaceuticals, Inc.
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