Anthera Halts VISTA-16 Clinical Study Due to Lack of Efficacy Following Recommendation by the Independent Data Safety Monitoring Board
HAYWARD, Calif., March 9, 2012 /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 recommended stopping the VISTA-16 clinical study due to a lack efficacy that could not be reasonably overcome in the remainder of the trial. The DSMB's recommendation was based on a review of the totality of the safety and efficacy data available for the VISTA-16 clinical study.
"Based on all the evidence we have seen regarding varespladib and secretory phospholipase and in light of previous study results, we were surprised by the recommendation from the DSMB," said Stephen Nicholls, MD, Cardiovascular Director of the Cleveland Clinic Coordinating Center for Clinical Research and chairman of the executive committee overseeing the VISTA-16 trial. "We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing given the potential benefits of this drug."
Anthera has closed enrollment in the phase 3 VISTA-16 clinical study and informed all investigators to remove patients from therapy immediately. "While the Data Safety Monitoring Board information we received today was both surprising and disappointing, our focus is on the best interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible," said Paul F. Truex, Anthera's President and Chief Executive Officer.
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.
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SOURCE Anthera Pharmaceuticals, Inc.
Posted: March 2012