Genzyme/Isis begin three mipomersen trials

Biotechnology major Genzyme and fellow USA-based Isis Pharmaceuticals have begun two new late-stage studies of mipomersen in  hypercholesterolemia patients, with a third currently screening  patients.

All three new trials are double-blind, placebo-controlled studies in  which patients will be randomized 2:1 to receive a 200mg dose of  mipomersen or placebo weekly for 26 weeks, with percent change in  low-density lipoprotein cholesterol as the primary endpoint.

The trial currently screening patients will evaluate the safety and  efficacy of mipomersen in subjects with severe hypercholesterolemia who  are on a maximum tolerated, lipid-lowering regimen. The Phase III 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.