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

(p=0.24) (p=0.15) (p=0.23) (p=0.41) (p=0.60) (p=0.33)

ApoA-1 0% 0% -6% 1% 2% -6% -5%

(p=0.59) (p=0.66) (p=0.93) (p=0.67) (p=0.43) (p=0.04)

TC 2% 5% -15% -13% -42% -34% -23%

(p=0.72)(p=0.005) (p=0.009) (p<0.0001)(p=0.0001)(p=0.0001)

TG 0% 4% 4% -25% -41% -35% -15%

(p=0.60) (p=0.52) (p=0.38) (p=0.04) (p=0.02) (p=0.92)

P value = vs. placebo

* Primary endpoint analysis was 30 day post last dose, Day 59, in

cohorts treated for 5 weeks and 14 days post last dose, Day 99, in the

cohort treated for 13 weeks

** Per protocol, analysis excludes one patient enrolled in the

400 mg/week cohort who dropped out after receiving only one dose of

study drug

*** Statistical analysis of the 200 mg/week dose group treated for 13

weeks is versus a pooled placebo from all cohorts (n=14)

Table 2: Mipomersen Phase 1 and Phase 2 Summary of On-Treatment ALT

Elevations*

Percentage of subjects with ALT elevations

Max ALT** Placebo 30/50 100 200 >=300

mg/week mg/week mg/week mg/week

(N=40) (N=35) (N=35) (N=87) (N=106)

150-250 3% 3% 0% 3% 7%

IU/L

(3xULN-

5xULN***)

>250 IU/L 0% 0% 0% 0% 0%

(>5xULN***)

* On-treatment period encompasses the treatment period from first dose

to last dose

** Each subject is counted only once at maximum ALT reading

*** ULN is defined to be 50 IU/L

Table 3: Mipomersen Phase 1 and Phase 2 Summary of Entire Study ALT

Elevations*

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

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