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Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
Date:4/18/2011

following an acute coronary syndrome will translate into better treatment options for this high-risk patient population."

"VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS", commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee.  "We are excited to be continuing our efforts to bring forward this promising therapeutic."

VISTA-16 is a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical study which will enroll up to 6,500 high-risk ACS patients.  Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoint events have occurred.  High-risk patients are defined as patients who have risk factors that place them at a higher risk of experiencing a secondary coronary event.  These risk factors include previous cardiovascular disease, diabetes, or metabolic syndrome.  Within 96 hours of experiencing primary ACS, patients are treated with varespladib or placebo once-daily in combination with a physician-prescribed dose of atorvastatin for 16 weeks — the period when patients have the highest risk of experiencing a secondary cardiovascular event.  As per a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the primary endpoint of the VISTA-16 study will be a reduction in major adverse coronary events (MACE), which was defined by recent FDA draft guidance as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.

About Varespladib and sPLA2

Varespladib is a potent oral inhibitor of the pro-inflammatory enzyme secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory condi
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SOURCE Anthera Pharmaceuticals, Inc.
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