FRANCIS Clinical Trial to Measure Impact of Varespladib on ACS Patients
August 26, 2008 - Anthera Pharmaceuticals Inc. yesterday announced the initiation of the FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) clinical trial to examine the impact of varespladib when administered to patients within 96 hours of an acute coronary syndrome (ACS) event.
Designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk, the FRANCIS trial will enroll up to 500 patients who will be treated for a minimum of six months. The study will be conducted at sites in North America and Europe to 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, nonfatal stroke, nonfatal 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). In previous clinical trials, according to Anthera, varespladib, a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2), has demonstrated marked improvements in independent markers of cardiovascular risk including, a near complete suppression of the target enzyme sPLA2, a clinically meaningful and statistically significant reduction in "bad" LDL cholesterol, and a reduction in C-reactive protein a known marker of inflammation.
"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 ACS patients," said James Pennington, M.D., executive vice president and chief medical officer of Anthera Pharmaceuticals, Inc.
For more information: www.anthera.com/