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Isis Pharmaceuticals Reports Fifth Positive Phase 2 Data Set for ISIS-APOCIII Rx Showing Significant Reductions in Triglyceride and ApoC-III Levels
Date:11/18/2013

II is an important regulator of triglycerides in the blood.  As such, a drug targeted to reduce ApoC-III should have a profound and positive effect on triglyceride levels," said John Kastelein, M.D., Ph.D., professor of medicine, chairman of the department of vascular medicine, Academic Medical Center, University of Amsterdam.  "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.  Based on the comprehensive Phase 2 data for ISIS-APOCIIIRx, I am very encouraged about the therapeutic potential for ISIS-APOCIIIRx in patients with severely high triglycerides, especially for use in FCS patients who have extremely high triglyceride levels and very limited therapeutic options."

The monotherapy portion of the Phase 2 study of ISIS-APOCIIIRx is a double-blind, randomized, placebo-controlled 13-week study designed to assess the safety and activity of ISIS-APOCIIIRx in patients with very high to severely high triglyceride levels (between 440 and 2,000 mg/dL).  In this study, patients received 100 mg, 200 mg or 300 mg dose of ISIS-APOCIIIRx, or placebo via weekly subcutaneous injections for 13 weeks.  Patients treated with 300 mg ISIS-APOCIIIRx experienced dose-dependent, robust, prolonged and statistically significant mean reductions in apoC-III, triglycerides and apoC-III-associated VLDL particles of 80, 71 and 88 percent from baseline, respectively.  Furthermore, these patients demonstrated a statistically significant mean increase of 46 percent from baseline in HDL-C.  In this study ISIS-APOCIIIRx was found to be generally safe and well tolerated.  The most common adverse event (AE) was injection site reactions, which were infrequent, predominantly mild and typically resolved rapidly.  There wer
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SOURCE Isis Pharmaceuticals, Inc.
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