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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

-70% (p<0.0001)Triglycerides

[# patients achieving

triglyceride level <150

mg/dL]

-7.7%

 

[0/8]

-49.7% (p=0.03)

 

[5/8]

-63.9% (p=0.003)

 

[7/10]ApoC-III VLDL

+8.4%

-65.9% (p=0.0006)

-77.4% (p=0.0003)HDL-C

+5.9%

+47.4% (p=0.02)

+51.8% (p=0.008)P value = vs. placebo + fibrate.

After 13 weeks of dosing, robust and prolonged, statistically significant mean percent reductions from baseline in apoC-III, triglycerides and VLDL-associated apoC-III particles were observed in both dose cohorts.  Furthermore, patients treated with ISIS-APOCIIIRx demonstrated a rapid, prolonged and statistically significant mean percent increase from baseline in HDL-C in both dose cohorts with no statistically significant increase in low-density lipoprotein cholesterol (LDL-C) or non-HDL-C. The effects of ISIS-APOCIIIRx observed on these lipid parameters were in addition to those achieved with each patient's existing therapeutic regimen of fibrates.

"Patients with very high levels of triglycerides are at significant risk for cardiovascular disease, diabetes, pancreatitis and other complications.
For these patients, there are very limited treatment options.  Fibrates have been shown to reduce triglycerides; however fibrate therapy is not always effective nor widely used by these patients," said Daniel Gaudet, M.D., Ph.D., from the department of medicine, University of Montreal and scientific director, Genome Quebec Biobank Technology Center.  "The data presented today on ISIS-APOCIIIRx are very encouraging because they show that ISIS-APOCIIIRx is additive to fibrates and are consistent with Isis' previous Phase 2 data in patients with moderately elevated triglycerides and type 2 diabetes. In both studi
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SOURCE Isis Pharmaceuticals, Inc.
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