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Study Presented at ACC Shows Treatment With ISIS 301012 Added to,Statins for Only 5 Weeks Results in 75% of Patients Achieving LDL-C,Levels Less Than 100 mg/dL and 50% of Patients Achieving LDL-C,Levels of Less Than 70 mg/dL

pectations, and we are looking forward to taking the next steps toward bringing it to market for patients who need to improve their cholesterol levels. Our next step for the routine high cholesterol population is to conduct a longer-term Phase 2 study in patients in combination with statins, in which we expect to use induction doses of 200 to 300 mg/week and define maintenance doses in the range of 100 to 200 mg/week."

ISIS 301012 Coadministered with Statins

This randomized, double-blinded, placebo-controlled, dose-escalation study initially included five weeks of treatment at doses of 30, 100, 200, and 300 mg/week. Because ISIS 301012 was well tolerated in these cohorts, the study was expanded to include a 400 mg/week five-week treatment group and two longer-term treatment cohorts; results of dose cohorts through 300 mg/week were presented previously, results from the 400 mg/week cohort were presented today, and results from the longer-term cohorts will be presented later in the year. Patients in the five-week study had median baseline LDL-C levels between 107 and 168 mg/dL and had been on stable doses of < / = 40 mg of simvastatin or atorvastatin for at least three months, with a median statin treatment duration of 4 years. At a dose of 400 mg/week, patients receiving ISIS 301012 achieved median reductions of 51% in apoB, 47% in LDL-C, and 35% in TG beyond the levels they had already achieved on stable statin doses. ISIS 301012 treatment had no effect on HDL-cholesterol levels (HDL-C).

Interestingly, in this short-term study, increasing the dose from 300 mg/week to 400 mg/week did not result in further lipid lowering activity represented as median % changes from baselines. This apparent plateau in % reductions may be due to the higher baseline values in the 300 mg/week cohort relative to the 400 mg/week cohort. Indeed, the 400 mg/week cohort did achieve lower median absolute levels of both apoB (55 mg/dL at 400 mg/week versus 61 mg/dL at 300 m
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