Anthera Initiates Acute Coronary Syndrome Study
Anthera Pharmaceuticals has started the Francis clinical trial designed to examine the impact of varespladib when administered to patients within 96 hours of an acute coronary syndrome event.
The Francis trial is designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk. It will enroll up to 500 patients that will be treated for a minimum of six months. The study will be conducted at sites in North America and Europe.
Francis will provide insight into the prevention of secondary major adverse cardiovascular events (MACE) over the duration of the trial. In this study, MACE is defined as a composite endpoint consisting of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a subset of revascularization following the initial event. During the course of the study, patients will receive therapeutic standard of care in addition to high dose Lipitor (atorvastatin).
James Pennington, executive vice president and chief medical officer of Anthera Pharmaceuticals, said: “Based upon the success of varespladib in two previous Phase II clinical trials in patients with cardiovascular disease in which it demonstrated lipid-lowering and anti-inflammatory benefits, we look forward to further evaluating the impact of varespladib on the hyper-inflammatory state presented by acute coronary syndrome patients.”