Tuesday, July 23, 2013

Isis Hypertriglyceridemia drug demonstrates robust improvement in lipid profile as add on to fibrates

In a Phase 2 double blind placebo controlled study comparing ISIS-APOCIII­Rx   as add on to fibrates to fibrates alone, ISIS-APOCIII­Rx  demonstrated a statistically significant reduction in triglycerides, ApoC-III VLDL and increase in HDL.  The study enrolled patients with high to severely elevated triglyceride levels (between 225 and 2,000 mg/dL) 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
Isis's drug raised the level of 'good' cholesterol in the blood by up to 52 percent.

ISIS-APOCIIIRx was developed using the company's antisense technology, which works by inhibiting a cell's production of disease-causing protein. Isis is using the technology to develop drugs to treat heart diseases, metabolic diseases and cancer.  The U.S. Food and Drug Administration in January approved Isis's drug Kynamro to treat a rare genetic disorder that causes high levels of bad cholesterol.

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