Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study; Daniel K. Spiegelman Joins Board of Directors
HAYWARD, Calif., Feb. 8 /PRNewswire/ — 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 U.S. Food and Drug Administration (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.
About the VISTA-16 Study
The planned multinational, randomized, double-blind, placebo-controlled Phase 3 acute coronary syndrome VISTA-16 study will enroll up to 6,500 patients in up to 15 countries and up to 500 centers. Patients will be treated with A-002 or placebo and any dose of atorvastatin for 16 weeks and survival status will be obtained for patients six months after the completion of dosing. The primary endpoint of the VISTA-16 study will be to determine whether 16 weeks of once-daily treatment with A-002 plus a dose of atorvastatin is superior to placebo plus atorvastatin in the time to the first occurrence of the combined endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization as defined by recent FDA draft guidance.
About Acute Coronary Syndrome
The American Heart Association defines acute coronary syndrome as any group of clinical signs and symptoms related to acute myocardial ischemia, or heart muscle damage. Clinical studies have shown that patients experiencing an acute coronary syndrome suffer from significant inflammatory activity and abnormal lipid profiles.
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 ready 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 secretory phospholipase A2, or 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, or CAD. Anthera’s Phase 2 ready product candidate, A-623, targets elevated levels of B-lymphocyte stimulator, or BLyS, which has been associated with a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus, or lupus. Anthera has worldwide rights to its product candidates, with the exception of Japan, where Shionogi & Co., Ltd. retains commercial rights to its sPLA2 product candidates.
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SOURCE Anthera Pharmaceuticals