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VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
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