Navigation Links
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
Date:2/8/2010

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.

CONTACT: Juliane Snowden of Burns McClellan, Inc., jsnowden@burnsmc.com or 212.213.0006.

SOURCE Anthera Pharmaceuticals


'/>"/>
SOURCE Anthera Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Antheras Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome
2. Following Encouraging Results Anthera to Continue IMPACTS Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
3. Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
4. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
5. DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
6. Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
7. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
8. Antheras A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
9. Anthera Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
10. Anthera Announces Completion of Enrollment and Dosing in Phase II Trial of A-002 for the Treatment of Cardiovascular Disease
11. Novavax Terminates Negotiations with ROVI Pharmaceuticals for Influenza Vaccine Collaboration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... 2016  Compass Diversified Holdings (NYSE: CODI ... of leading middle market businesses, announced today its consolidated ... 2016. First Quarter 2016 Highlights , ... or "Cash Flow") of $13.6 million for the first ... $15.0 million for the first quarter of 2016; ...
(Date:5/4/2016)... COUNTY, Calif. , May 4, 2016  It,s time for an upgrade. There ... shown on a brilliant 3.5 inch LCD, the illustrious DVMAXX HD  offers unparalleled ... brands as well as a world class manufacturer of innovative technology.  Photo ... ... ...
(Date:5/4/2016)... YORK , May 4, 2016 ... Share, Development, Growth and Demand Forecast to 2022 - Industry ... User (Hospital, Diagnostic Center and Others)" by P&S Market Research, ... $4,894.3 million in 2015, and it is expected to grow ... type, the high slice type segment is expected to witness ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... May 04, 2016 , ... Connor Sport Court ... for the 2016 NCAA Men’s National Collegiate Volleyball Championship. , Sport ... championship to be held May 5-7 at Pennsylvania State University’s Rec Hall in ...
(Date:5/4/2016)... ... May 04, 2016 , ... ... families of Camas and Vancouver, WA, has announced the latest beneficiary of ... Breast Cancer Foundation and their Mammography Program, which provides free mammograms and ...
(Date:5/4/2016)... ... May 04, 2016 , ... Level 10 Head Over Heels Athletic ... to the University of Arizona for the fall of 2019. , After a ... Brovedani’s commitment to the GymCats came from her connection with the coaching staff and ...
(Date:5/4/2016)... MA (PRWEB) , ... May 04, 2016 , ... ... help fund Dr. Todd Rider's research and development of DRACO broad-spectrum antiviral therapeutics. ... In the campaign that starts on May 3, 2016 at http://igg.me/at/EndTheVirus ...
(Date:5/4/2016)... ... May 04, 2016 , ... Olshan ... commercial real estate proudly announced that its service-based charitable program, Olshan Outreach, successfully ... portfolio-wide will continue Olshan Properties’ annual philanthropic tradition in 2016 with the ‘Fight ...
Breaking Medicine News(10 mins):