( isease trials are typically single-arm...)Isis Pharmaceuticals Reports Positive Phase 2 Data for ISIS 301012,in Familial Hypercholesterolemia Patients Presented at ACC,Health

There were no serious adverse events in the study, and ISIS 301012 was well tolerated. A single patient had a transient increase in liver transaminase (ALT) that exceeded three times the upper limit of normal (3xULN), which the investigator attributed to alcohol as documented by patient admission.

ISIS 301012 in Homozygous Familial Hypercholesterolemia

The data presented are part of a single-arm, open-label, dose-escalation study. Because the study was designed principally to assess the safety of ISIS 301012 in HoFH and in combination with high-dose concurrent lipid- lowering therapies, the protocol initially called for five weeks of dosing. Based on a strong safety profile at five weeks with doses through 200 mg/week, the study was amended to include a cohort of patients dosed at 300 mg/week for three months, and it is that cohort for which preliminary data were subject of today's presentation. Full results from the study will be presented in the future, as will data from the ongoing double-blind, placebo-controlled heterozygous FH study.

    Table 1: ISIS 301012 in HoFH, Summary of Results

    Lipid values are presented in mg/dL and % change from baseline.



                       Patient 1        Patient 2             Patient 3


                                   80 mg atorvastatin +

    Concurrent           80 mg       10 mg ezetimibe +   40 mg rosuvastatin +

    therapies        atorvastatin  625 mg colesevelam +     10 mg ezetimibe

                                       1 g niacin


    Age (years)           23                   48                   32


    Lipids:    Baseline   Day    %   Baseline  Day   %    Baseline  Day   %

                           85  change           78 change            43 change



    apoB-100       369    191 
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