Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Isis Pharmaceuticals has initiated a phase II study of its experimental drug ISIS 301012 in combination with a statin in patients with high cholesterol.
Subscribe to our email newsletter
The study is part of a broad phase II development program of ISIS 301012, a second-generation antisense drug. ISIS 301012 selectively reduces apoB-100, a target critical to the synthesis and transport of the “bad” cholesterol involved in heart disease. Lowering cholesterol levels is a key component in the prevention and management of cardiovascular disease.
The phase II study is designed to evaluate the safety and efficacy of ISIS 301012 in patients on stable simvastatin therapy, who are not achieving their cholesterol targets. In the study, patients will be dosed with 30 mg, 100 mg or 200 mg of ISIS 301012 over a 5-week treatment period followed by an 8-week post-treatment evaluation period.
“Our comprehensive phase II development program will allow us to examine the broad profile of ISIS 301012 as an add-on therapy to reduce cholesterol in patients who can not reach their therapeutic target, or as an alternative for patients who can not tolerate currently available therapies,” said Dr Mark Wedel, vice president of clinical research and chief medical officer of Isis Pharmaceuticals.