Isis Begins Phase II Program for Cholesterol Drug

Isis Pharmaceuticals has initiated the development program of ISIS 301012 in patients with familial hypercholesterolemia (FH), a genetic disorder that causes extremely high cholesterol levels and results in the early onset of heart disease. ISIS 301012, a second-generation antisense drug, reduces levels of apoB-100, a protein critical to the synthesis and transport of the “bad” cholesterol involved in heart disease—low density lipoprotein cholesterol (LDL-C) and very low density lipoprotein (VLDL). Lowering cholesterol levels is a key component in the prevention and management of cardiovascular disease.

The Phase II studies will evaluate the safety and efficacy of ISIS 301012 in patients with FH who are not achieving their cholesterol target levels on lipid-lowering therapy. In the studies, patients will be dosed with 50 mg, 100 mg or 200 mg of ISIS 301012 for six weeks treatment period and then followed for five months.