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Isis Pharmaceuticals Inc Announces Positive Phase 1 Data Demonstrating ISIS-APO(a) Rx Produces Significant Reductions in Lp(a) Levels


Saturday, 16 Nov 2013 05:10pm EST 

Isis Pharmaceuticals Inc announced positive results from a Phase 1 study with ISIS-APO(a)Rx. In this study, healthy volunteers treated with ISIS-APO(a)Rx achieved dose-dependent reductions of up to 95% in lipoprotein(a), or Lp(a), an independent risk factor for coronary heart disease. The Phase 1 study of ISIS-APO(a)Rx was a blinded, placebo-controlled, dose-escalation study in healthy volunteers. The study was designed to assess the safety, tolerability and pharmacokinetics of ISIS-APO(a)Rx. ISIS-APO(a)Rx was evaluated in single and multiple doses ranging from 50 mg per week up to 400 mg per week for the single dose and 100 mg, 200 mg and 300 mg for the multiple dose. After only 3 weeks of dosing, subjects in the 100, 200 and 300 mg multiple-dose cohorts displayed a mean reduction of Lp(a) of 36, 62 and 82%, respectively, from baseline. The incoming range of Lp(a) in the study ranged from 10 mg/dL to 98 mg/dL. ISIS-APO(a)Rx reduction of Lp(a) was independent of the baseline Lp(a) measurement. In addition to Lp(a) activity, subjects treated with 300 mg of ISIS-APO(a)Rx also experienced an up to 59%reduction in oxidized phospholipids, lipids that play an important role in proinflammatory and proatherogenic processes believed to be associated with Lp(a). In this study, ISIS-APO(a)Rx demonstrated a good safety profile and was generally well tolerated. 

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