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Isis Reports Phase 2 Data on ISIS-APOCIII Rx Showing Significant Reductions of ApoC-III and Triglycerides in Patients With High Triglycerides Taking Fibrates
Date:7/22/2013

CARLSBAD, Calif., July 22, 2013 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced data from a Phase 2 study of ISIS-APOCIIIRx in patients with high to severely high triglycerides on stable doses of fibrates.  In this study, patients treated with ISIS-APOCIIIRx experienced reductions of up to 70 percent in apolipoprotein C-III (apoC-III) and up to 64 percent in triglycerides.  In addition, patients treated with ISIS-APOCIIIRx experienced an up to 52 percent increase in high-density lipoprotein cholesterol (HDL-C), the 'good' cholesterol, and an up to 77 percent reduction in apoC-III-associated very low-density lipoprotein (VLDL) particles.  Isis is also evaluating ISIS-APOCIIIRx in this Phase 2 study as a monotherapy in patients with severely high triglycerides and plans to report these data at the European Society of Cardiology on August 31 in Amsterdam.

The Phase 2 study of ISIS-APOCIII­Rx was a double-blind, randomized, placebo-controlled 13-week study designed to assess the safety and activity of ISIS-APOCIIIRx.  The portion of the study reported today was conducted in patients with high to severely elevated triglyceride levels (between 225 and 2,000 mg/dL) on stable doses of fibrates. 

Table 1:  ISIS-APOCIIIRx Produced Statistically Significant Reductions of Triglycerides, ApoC-III and ApoC-III Associated VLDL in a Phase 2 Study in Patients With High Triglyceride Levels Treated With Stable Doses of Fibrates.  Mean % Changes From Baseline at Primary Endpoint.Placebo + Fibrate

(n=8)

ISIS-APOCIIIRx 200 mg + Fibrate 

(n=8)

ISIS-APOCIIIRx 300 mg + Fibrate

(n=10)ApoC-III

-2.2%

-59.4% (p<0.0001)


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SOURCE Isis Pharmaceuticals, Inc.
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