Navigation Links
Anthera Announces Completion of Safety Review by DSMB for VISTA-16
Date:12/14/2011

HAYWARD, Calif., Dec. 14, 2011 /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 met for the fifth time to review available safety data and has recommended the study continue without change.  The Company is awaiting the assessment of a pre-defined interim efficacy analysis of the primary endpoint, which is scheduled to occur after 50% of the primary endpoint events in the VISTA-16 clinical study have been collected, adjudicated and reviewed by the DSMB.  The primary endpoint of the VISTA-16 study is a composite of the time to occurrence of a secondary major adverse cardiovascular event consisting of unstable angina requiring urgent hospitalization, myocardial infarction, stroke and cardiovascular death.

About Varespladib and sPLA2

Varespladib is a potent oral inhibitor of a number of pro-inflammatory enzymes collectively known as secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS, and are associated with an increased risk for future ischemic events, such as a heart attack or even death. In Anthera's FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including C-reactive protein, IL-6, LDL-C and varespladib's target enzyme, sPLA2. Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk. VISTA-16 is an event driven clinical study evaluating the use of varespladib methyl in combination with Lipitor (atorvastatin calcium) to reduce secondary Major Adverse Cardiovascular Events in patients who have recently experienced an Acute Coronary Syndrome. In February 2010, Anthera received a SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients.

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 three late stage clinical products: varespladib methyl (A-002), A-001 and blisibimod (A-623). Varespladib methyl (A-002) and A-001 are designed to inhibit a novel enzyme target known as secretory phospholipase A2 (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. Blisibimod targets elevated levels of B-lymphocyte stimulator (BAFF) which have been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus) and rheumatoid arthritis.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2010 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2011. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.


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

Related medicine technology :

1. Anthera Pharmaceuticals Promotes Dr. Debra Odink to Chief Technology Officer
2. Anthera Pharmaceuticals Reports 2011 Third Quarter Financial Results and Operational Update
3. Anthera Announces Last Patient Enrolled in PEARL-SC Study
4. Anthera Pharmaceuticals Announces Notice of Allowance of U.S. Patent Application Covering A-002 Plus Statin Compositions
5. Anthera Pharmaceuticals Reports 2011 Second Quarter Financial Results and Operational Update
6. Anthera Pharmaceuticals Announces Completion of Public Offering of Common Stock
7. Anthera Pharmaceuticals Announces Pricing of Public Offering of Common Stock
8. Anthera Pharmaceuticals Reports 2011 First Quarter Financial Results and Operational Update
9. Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
10. Anthera Announces Conference Call to Discuss Analytical Method and Timing of Upcoming VISTA-16 Biomarker Analysis
11. Anthera Pharmaceuticals Names Lawrence Rosania as Vice President of Global Regulatory Affairs and Compliance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... -- CSI Specialty Group (CSI) expanded its specialty pharmacy ... Pharmacy Podcast. A free, weekly show, the Specialty Pharmacy ... discussion and context amongst specialty pharmacy peers and professionals. ... The Specialty Pharmacy Podcast, hosted by industry leader ... DiMascio, CHE, CMCE, CPC, is available for streaming and/or ...
(Date:2/10/2016)... and SAN DIEGO , Feb. 10, ... global leader in viral gene therapy manufacturing, and Renova™ ... congestive heart failure and other chronic diseases, have entered ... manufacturing process and produce cGMP-grade RT-100 (Ad5.hAC6) Drug Product ... --> --> This relationship ...
(Date:2/10/2016)... -- Urologix, the market leader for in-office minimally invasive ... (BPH), announces new private ownership and is operating as ... industry veteran of more than 20 years, has been ... Plymouth, Minn. The company,s two ... RF Therapy, will continue to be broadly available and ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... As part of its ongoing series of ... Each webinar features a dynamic expert and thoughtful presentation to give attendees a ... facilities. Both events are free to attend, but registration is required. ...
(Date:2/10/2016)... ... February 10, 2016 , ... Emergency rooms provide emergency care to stabilize ... can leave patients with dental emergencies at risk of losing a tooth or their ... care. , Common dental emergencies include:, , Avulsed or ...
(Date:2/10/2016)... ... February 10, 2016 , ... Intalere’s 2016 Executive ... than 200 of the country’s top healthcare executives to share insights on transformational ... of the Forum is the provider-centric perspective, experience, expertise and strategy shared by ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... award winner and inspirational speaker Jan Fox will serve as keynote speaker at ... will provide participants with tools to more effectively communicate with their own organizational ...
(Date:2/10/2016)... ... February 10, 2016 , ... Everseat has joined ... readily available to physicians. The integration will enable Allscripts users to post open ... Everseat’s free mobile app. , The partnership gives Everseat substantial added power to ...
Breaking Medicine News(10 mins):