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Isis Reports Phase 2 Data on ISIS-APOCIII Rx Showing Significant Reductions in Triglycerides and APOC-III in Patients with High Triglycerides and Type 2 Diabetes
Date:6/23/2013

ith high triglycerides and type 2 diabetes. ISIS-APOCIIIRx demonstrated a good safety profile in the study and was well tolerated in all subjects with no discontinuations, no clinically meaningful elevations in liver enzymes, no flu-like symptoms, no significant adverse events, and a low incidence of mild injection site reactions which were infrequent and typically resolved within a day or two.  

"Our focus is to bring ISIS-APOCIIIRx to the market for patients with severe hypertriglyceridemia.  These are patients who cannot reduce their triglycerides to safe levels with currently available medicines. We plan to report data from our ongoing Phase 2 program in very high triglyceride patients later this summer evaluating ISIS-APOCIIIRx in combination with fibrates and as a monotherapy," said Richard Geary, Ph.D., senior vice president of clinical development at Isis. "In the study we are reporting today, we observed rapid and prolonged reductions of apoC-III, triglycerides and other lipid parameters, as well as improvements in glucose control and insulin sensitivity. These data suggest that ISIS-APOCIIIRx could provide therapeutic benefit to patients with high triglycerides who are insulin insensitive, including patients who are obese or have type 2 diabetes. In addition, the positive effect of ISIS-APOCIIIRx on all atherogenic lipid parameters measured and the observed increase in HDL, significantly enhances the potential profile of the drug."

In this study, 11 patients were randomized 2:1 to receive a 300 mg dose of ISIS-APOCIIIRx or placebo via weekly subcutaneous injections for 13 weeks.  Patients entering the study had a mean apoC-III level of 14.3 mg/dL, a mean triglyceride level of 259 mg/dL and a mean HDL level of 43.4 mg/dL. 

ISIS-APOCIIIRx is an antisense drug that targets apoC-III, a gene produced in the l
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SOURCE Isis Pharmaceuticals, Inc.
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