ISIS PHARMACEUTICALS PRESENTS RESULTS OF CHOLESTEROL STUDIES

Isis Pharmaceuticals presented results from two Phase II clinical trials of ISIS 301012 p at the American Heart Association Annual Scientific Sessions in Chicago. In the first study reported, patients with high cholesterol on stable doses of statins were treated with ISIS 301012 for five weeks. Patients who received 300 mg/week of ISIS 301012 achieved a 51 percent reduction in LDL-cholesterol, a 42 percent reduction in total cholesterol and a 41 percent reduction in triglycerides beyond the levels achieved with statins alone.

Isis also presented new results from an ongoing study in which patients with high cholesterol were treated for three months with 300 mg/week of ISIS 301012 as a single agent. In this study, increasing the dose of ISIS 301012 to 300 mg/week further reduced atherogenic lipids, with improvements in LDL-cholesterol, total cholesterol and triglycerides of 62 percent, 46 percent and 43 percent, respectively. The drug was well-tolerated in both studies.

The study of ISIS 301012 coadministered with statins, a randomized, double-blinded, placebo-controlled, dose-escalation study, calls for five weeks of therapy at doses of 30, 100, 200, 300 and 400 mg/week. It was recently expanded to include longer-term treatment as well. The results are comparable to the reductions achieved with ISIS 301012 as a single agent and they are consistent with the data suggesting ISIS 301012 acts through a mechanism of lipid lowering that is independent of and complementary to the statin mechanism. The data further demonstrate that when coadministered with a stable dose of statins, ISIS 301012 displays a linear dose response relationship

In the study of ISIS 301012 as a single agent, a randomized, double-blinded, placebo-controlled, dose-escalation trial, patients with high were treated for three months. Study data demonstrate that in contrast to statins, ISIS 301012 causes linearly increasing reductions of atherogenic lipids as doses are increased.