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Isis Initiates Phase 2 Study of ISIS-APOCIIIRx in Patients with Hypertriglyceridemia
Date:5/4/2012

nt cardiovascular risk factor.  Reducing both apoC-III and triglyceride levels could provide significant therapeutic benefits.  For example, a drug that lowers triglycerides in patients with severe hypertriglyceridemia would undoubtedly reduce their immediate risk of pancreatitis and in the long-term, might also reduce their risk of cardiovascular disease.  Furthermore, in patients with type 2 diabetes, reducing apoC-III and triglycerides may lead to improved insulin sensitivity and improvement of metabolic syndrome, both of which would be highly desirable."

The Phase 2 study is a randomized, placebo-controlled, dose-response study evaluating the safety and efficacy of ISIS-APOCIIIRx in patients with very high triglycerides.  The three-month study will enroll approximately 100 patients who have triglyceride levels of 500 mg/dL or higher.  The study will evaluate ISIS-APOCIIIRx as a monotherapy and in combination with fibrates in patients.  The endpoints for the study include measurements of triglycerides both before and after eating and apoC-III levels in blood. 

"In our Phase 1 study, treatment with ISIS-APOCIIIRx produced rapid, dose-dependent median reductions of up to 44 percent in plasma triglycerides and up to 78 percent in apoC-III protein, with two out of the three subjects in the highest dose group achieving undetectable levels of apoC-III.  These data underscore the potential therapeutic benefit a selective apoC-III inhibitor could offer patients with elevated levels of triglycerides and apoC-III," said Richard Geary, Ph.D., Senior Vice President of Development at Isis. "Following the encouraging results we observed in our Phase 1 study in healthy volunteers, we hope to achieve similar triglyceride reductions in patients with very high triglycerides in the Phase 2 study we have just initiated.  Assuming these data are replicated, we plan to move rapidly into a Phase 3 study in the m
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SOURCE Isis Pharmaceuticals, Inc.
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