Genzyme (GENZ) and Isis (ISIS) Begin New Clinical Trials of Mipomersen

January 12, 2009 9:39 AM EST

Genzyme Corp. (Nasdaq: GENZ) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced that they have begun two new studies of mipomersen, a novel lipid-lowering drug in late-stage development, and a third is currently screening patients. These three trials will provide additional data on mipomersen in high-risk patient populations. The new studies, together with ongoing trials, will also substantially increase the size of the database of patients treated with mipomersen over the next 18 months.

The trial currently screening patients will evaluate the safety and efficacy of mipomersen in patients with severe hypercholesterolemia who are on a maximally tolerated lipid-lowering regimen (previously referred to as apheresis-eligible patients). This phase 3 study includes patients who are not on LDL cholesterol apheresis but who have such severely elevated LDL-C levels that they are eligible for the procedure, and will enroll up to 75 patients.

In addition, the companies recently initiated a phase 3 trial in hypercholesterolemic patients on maximally tolerated dosages of statins who are at high risk for coronary heart disease. This study will enroll up to 180 patients. The companies have also begun a new phase 2 study in high-risk, high-cholesterol patients who are intolerant to statins, which will enroll up to 30 patients.

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