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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

tions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD).  In Anthera's FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including CRP, IL-6, LDL-C and varespladib's target enzyme, sPLA2.  Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk.  In February 2010, Anthera received an SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients.  The next substantial review of clinical safety and efficacy data will be conducted after 50 percent of the anticipated primary endpoints have occurred.  At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint of the VISTA-16 Study.  This review is expected to take place in the second half of 2011.    

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera's Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythema
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SOURCE Anthera Pharmaceuticals, Inc.
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