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Isis Reports Positive Phase 1 Data Demonstrating ISIS-APOCIIIRx Produces Significant Reductions in apoC-III Protein Levels and Triglycerides
Date:12/6/2011

gle and multiple doses ranging from 50 mg per week up to 400 mg per week in 32 subjects.  

After only four weeks of dosing, subjects in the 200 mg and 400 mg multiple-dose cohorts displayed a median reduction of 71 percent and 78 percent in apoC-III levels, respectively, with two of the three treated subjects at the 400 mg dose reaching undetectable levels of apoC-III.  Additionally, in the 200 mg and 400 mg dose cohorts, subjects that received ISIS-APOCIIIRx had a median reduction in blood triglyceride levels of 43 percent and 44 percent, respectively, from baseline.  These statistically significant reductions were sustained for up to four weeks after the last dose.  ISIS-APOCIIIRx demonstrated a good safety profile and was well tolerated in all subjects with no clinically meaningful elevations of transaminase enzymes and no significant adverse events.  Isis will report the full data from this study at an upcoming scientific conference in 2012.

"In this Phase 1 study we observed substantial dose-dependent reductions of apoC-III protein and triglycerides, two independent risk factors for cardiovascular disease.   This is very encouraging data and underscores the therapeutic potential that a selective apoC-III inhibitor could offer patients with elevated levels of triglycerides and other atherogenic lipids, such as apoC-III.  In addition, since ISIS-APOCIIIRx specifically reduces apoC-III, it should substantially reduce triglycerides without the undesirable side effects that are associated with current therapies," said Walter Singleton, M.D., Vice President, Development and Chief Medical Officer at Isis.  "ISIS-APOCIIIRx is a key component of our cardiovascular franchise strategy to treat all aspects of cardiovascular disease by targeting pro-inflammatory and other atherogenic particles.  We plan to initiate a proof-of-concept Phase 2 study evaluating the efficacy of ISIS-APOCIIIRx in treatment-naive pat
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SOURCE Isis Pharmaceuticals, Inc.
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