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Isis Reports New Data for Mipomersen in Routine High Cholesterol Patients and Provides Cumulative Safety Summary
Date:11/13/2007

mersen was well tolerated throughout the study.

Further, Isis reported results of an integrated safety analysis including data from more than 250 subjects treated with mipomersen in Phase 1 and Phase 2 studies. This analysis demonstrates that mipomersen has been well tolerated and that treatment with mipomersen did not result in evidence of liver toxicity. Among all subjects who received mipomersen, there were no instances of transaminase (ALT) elevations associated with two-fold increase in bilirubin or any other signs or symptoms of liver dysfunction. While on treatment, 3% of subjects treated with placebo and 3% of subjects treated with 200 mg/week mipomersen experienced ALT elevations of 150-250 IU/L. During the entire study periods, including dosing plus 90 day follow up, 5% and 7% of subjects treated with placebo or 200 mg/week of mipomersen, respectively, experienced ALT elevations of 150-250 IU/L. The most common adverse event was mild to moderate injection site reactions.

According to Jeffrey Jonas, M.D., Executive Vice President, Isis Pharmaceuticals, "Our clinical experience continues to demonstrate the lipid-lowering activity of mipomersen, which has been equally effective across multiple patient populations both as a single agent and in combination with lipid-lowering therapies. Furthermore, mipomersen's lipid-lowering effects have been highly predictable. As we expected, extending treatment from five to 13 weeks results in further lipid lowering, increasing LDL-C reductions from 30% to 48%.

"In addition, we have now dosed over 250 subjects with mipomersen and are able to present an extensive integrated safety summary. We have explored a full dose range for mipomersen as a single agent and in combination with moderate to maximal lipid-lowering therapies, and we have exposed subjects to aggressive loading and induction schedules. Mipomersen continues to display an attractive safety profile. The primary adverse event in our studies has b
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SOURCE Isis Pharmaceuticals, Inc.
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