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Isis Pharmaceuticals Inc Announces Phase 2 Data on ISIS-APOCIII Rx Showing Substantial Reductions of Triglycerides and Apoc-III in Patients with Familial Chylomicronemia


Saturday, 21 Sep 2013 11:10am EDT 

Isis Pharmaceuticals Inc announced data from a Phase 2 study of ISIS-APOCIIIRx as a monotherapy in patients with familial chylomicronemia syndrome, or FCS. FCS is a rare orphan disease characterized by severely high triglyceride levels that affects an estimated 3,000 to 5,000 patients worldwide. In this study, three patients with FCS treated with ISIS-APOCIIIRx achieved substantial reductions in triglycerides with all three patients achieving a triglyceride level below 500 mg/dL, which substantially reduces the risk of an acute pancreatic event. Patients also achieved substantial reductions in apoC-III and apoCIII-associated very low-density lipoprotein-cholesterol (VLDL-C) particles. 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 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%. In addition, these patients experienced positive effects on other lipid parameters, including HDL-C, apoC-III and apoC-III-associated VLDL-C. 

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41.83
0.63 +1.53%
11:43am EDT