Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study
Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, announced today that it reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the Phase 3 clinical study named VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks) for its lead product candidate, A-002, an oral sPLA2 inhibitor, in combination with HMG-CoA reductase inhibitor, or statin, therapy for short-term (16-week) treatment of patients experiencing an acute coronary syndrome. This pivotal study, which is expected to begin in the first half of this year and to be completed 18 months thereafter, is expected to enroll up to 6,500 patients. Patients will be randomized within 96 hours of an acute coronary syndrome and will receive 16 weeks of either once-daily of A-002 or placebo in addition to a dose of atorvastatin.
In addition, Anthera today announced that it has appointed Daniel K. Spiegelman to its Board of Directors and as Chairman of the Audit Committee of the Board of Directors. Mr. Spiegelman provides management and financial consulting services to biotechnology companies. From 1998 to 2009, Mr. Spiegelman served as Senior Vice President and Chief Financial Officer of CV Therapeutics, Inc., a biopharmaceutical company that was acquired by Gilead Sciences, Inc. in 2009. From 1991 to 1998, Mr. Spiegelman served at Genentech, Inc., most recently as Treasurer. Mr. Spiegelman also serves on the board of directors of Affymax, Inc., Cyclacel Pharmaceuticals, Inc., Omeros Corporation and Oncothyreon, Inc., all publicly traded biopharmaceutical companies. Mr. Spiegelman holds a B.A. in economics from Stanford University and an M.B.A. from the Stanford Graduate School of Business.