Anthera commences enrollment in pivotal VISTA-16 Phase 3 clinical study of varespladib

Jun 23 2010

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced patient enrollment has commenced in the Company's pivotal VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome for 16 Weeks) Phase 3 clinical study of varespladib (A-002).  High-risk patients are defined as those who have additional disease characteristics that increase their likelihood of experiencing another coronary event; these characteristics include a history of previous cardiovascular disease, age, diabetes, or metabolic syndrome.

"Current best practice to slow coronary artery disease (CAD) progression and reduce the risk of a subsequent cardiovascular event is directed at the treatment of individual cardiovascular risk factors such as high cholesterol or clotting. The VISTA-16 study with varespladib is designed to validate the hypothesis that reduction of inflammation, particularly following an ACS, leads to improved outcomes in patients with cardiovascular disease. The enrollment of patients in VISTA-16 is an important milestone for the development of varespladib," stated Colin Hislop, M.D., Anthera's Senior Vice President and Chief Medical Officer. "I am particularly pleased that we are enrolling patients in both the United States and Europe as part of our initial roll out of the study. We look forward to the first DSMB review after 1000 patients have been randomized and treated."

"We have made major advances in treating patients with heart disease in terms of lowering blood pressure and improving lipid profiles, but there remains a substantial risk of clinical events," said Stephen Nicholls, M.D., Ph.D., Cardiovascular Director, Cleveland Clinic Coordinating Center for Clinical Research (C5 Research), who is leading the study. "We are excited to be conducting a trial that examines inflammation, especially in terms of trying to develop a therapy that specifically reduces inflammation within the plaque."

SOURCE Anthera Pharmaceuticals, Inc.