Isis Pharmaceuticals, Inc. (ISIS) announced the initiation of a Phase 2 study evaluating ISIS-APOCIIIRx in patients with hypertriglyceridemia. 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. The company said, "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 most severe patients with triglyceride levels greater than 1,000 mg/dL who have been unable to control their triglyceride levels with currently available treatments."
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