Dec. 14, 2011
/PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced that the VISTA-16 Data Safety Monitoring Board (DSMB) has met for the fifth time to review available safety data and has recommended the study continue without change. The Company is awaiting the assessment of a pre-defined interim efficacy analysis of the primary endpoint, which is scheduled to occur after 50% of the primary endpoint events in the VISTA-16 clinical study have been collected, adjudicated and reviewed by the DSMB. The primary endpoint of the VISTA-16 study is a composite of the time to occurrence of a secondary major adverse cardiovascular event consisting of unstable angina requiring urgent hospitalization, myocardial infarction, stroke and cardiovascular death.
About Varespladib and sPLA2
Varespladib is a potent oral inhibitor of a number of pro-inflammatory enzymes collectively known as secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS, and are associated with an increased risk for future ischemic events, such as a heart attack or even death. In Anthera's FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including C-reactive protein, 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. VISTA-16 is an event driven clinical study evaluating the use of varespladib methyl in combination with Lipitor (atorvastatin calcium) to reduce secondary Major Adverse Cardiovascular Events in patients who have recently experienced an Acute Coronary Syndrome. In
, Anthera received a SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients.
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 three late stage clinical products: varespladib methyl (A-002), A-001 and blisibimod (A-623). Varespladib methyl (A-002) and A-001 are designed to inhibit a novel enzyme target known as secretory phospholipase A2 (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. Blisibimod targets elevated levels of B-lymphocyte stimulator (BAFF) which have been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus) and rheumatoid arthritis.