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

een mild to moderate injection site reactions, which represent cosmetic inconveniences rather than safety concerns. We have not observed elevations in liver enzymes associated with increases in bilirubin or other signs or symptoms of liver dysfunction. During treatment and follow-up periods, subjects who received 200 mg/week mipomersen, our Phase 3 dose, experienced mild ALT elevations of 3-5xULN, similar to those in subjects who received placebo. These data are particularly impressive when one considers the fact that every subject was evaluated weekly and all ALT elevations were counted, whether confirmed or not. Based on this experience, we are very encouraged by mipomersen's overall safety and efficacy profile," concluded Dr. Jonas.

Table 1: Mipomersen in Routine High Cholesterol Patients Coadministered

with Statins

Summary of Results. Median % changes from baseline at primary endpoint.*

Per Placebo 30 100 200 300 400** 200***

Protocol mg/week mg/week mg/week mg/week mg/week mg/week

5 weeks 5 weeks 5 weeks 5 weeks 5 weeks 13 weeks

# of

patients 11 8 8 16 8 8 8

ApoB -1% 0% -20% -24% -52% -51% -42%

(p=0.80) (p=0.03) (p=0.004) (p<0.0001)(p=0.0004)(p<0.0001)

LDL-C -4% 4% -22% -30% -51% -47% -48%

(p=0.31) (p=0.01) (p=0.002) (p<0.0001) (p=0.008)(p<0.0001)

VLDL-C 7% 8% 10% -25% -63% -69% -17%

(p=0.84) (p=0.66) (p=0.38) (p=0.08) (p=0.02) (p=0.80)

Non-HDL-C -1% 8% -20% -22% -51% -49% -30%

(p=0.44) (p=0.02) (p=0.02) (p<0.0001) (p=0.008) (p=0.006)

HDL-C 9% 1% -4% 6% 5% 6% -4%


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SOURCE Isis Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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