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Isis Pharmaceuticals Updates Its Positive Phase 2 Data for ISIS,301012 in Familial Hypercholesterolemia Patients

45 246 -45% VLDL-C 18 10 -44% 33 24 -26% 30 20 -33% Non-HDL 669 328 -51% 230 123 -46% 475 266 -44% HDL-C 27 35 32% 29 28 -2% 27 31 15% ApoA-1 86 92 7% 109 109 0% 89 90 2% TC 695 363 -48% 258 151 -41% 502 297 -41% TG 90 49 -45% 163 118 -28% 151 99 -34% Lp(a) 104 36 -65% 140 128 -9% 108 54 -50%

ISIS 301012 was well tolerated and there were no serious adverse events in the study. 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's admission.

Jeff Jonas, M.D., Executive Vice President, Isis Pharmaceuticals, commented, "We are pleased to have successfully completed this initial evaluation of ISIS 301012 in the extreme disease setting of homozygous FH and in combination with the high doses of other lipid-lowering drugs typically prescribed to these patients. We are preparing to initiate our registration studies for FH shortly, and we look forward to presenting more FH data later in the year."

More about Phase 2 Trials for ISIS 301012

Isis has presented results of two double-blind, placebo-controlled Phase 2 dosing studies in patients with routine high cholesterol (polygenic hypercholesterolemia): a monotherapy study and a five-week coadministration with statins study. Ongoing studies include an extended three-month 200 mg/week treatment cohort in the statin coadministration study in polygenic hypercholesterolemia, and a dose-escalation study in patients with heterozygous FH. Data for each of these studies will be reported later in the year. For future studies, including the registration studies for FH and the long-term coadministration study planned for patients with routine
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