Navigation Links
Anthera Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
Date:10/24/2007

SAN MATEO, Calif., Oct. 24 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately-held biopharmaceutical company, reported results of a Phase II clinical trial of its first compound, A-002, for the treatment of cardiovascular disease. The trial results suggest that treatment with A-002 resulted in significant reductions in blood levels of total cholesterol, Non- High Density Lipoprotein Cholesterol (non HDL-C), and Low Density Lipoprotein Cholesterol (LDL-C), known as "bad" cholesterol, coupled with equally meaningful reductions of C-Reactive Protein (CRP), a recognized marker of inflammation and cardiovascular risk. Decreases in these levels with A-002 treatment were most significant among patients already on a background of statin therapy.

The Phase II PLASMA trial (Phospholipase Levels And Serological Markers of Atherosclerosis) was a multi-center, randomized, double-blind, placebo- controlled trial that enrolled approximately 400 patients with stable coronary heart disease in the U.S. and Ukraine. Subjects were randomized to receive one of four different doses of A-002 or placebo for up to eight weeks. Patients also received doctor-determined standard of care therapies. The primary endpoint, a reduction in secretory phospholipase A2 (sPLA2) levels was achieved with a high degree of statistical significance. In addition, the results also demonstrated clinically meaningful as well as statistically significant decreases in cholesterol levels (LDL-C, non-HDL and total cholesterol) in patients with stable coronary heart disease. Clinically meaningful decreases in inflammation, as measured by levels of CRP, were also observed in the relevant patient population. Full data will be presented in a scientific journal during 2008.

"The results of the PLASMA trial support our belief that A-002's unique mechanism of action has a dual effect on lipids and inflammation, which could provide significant therapeutic benefit to patients currently on background statin therapy," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. "Importantly, based upon these results, we will propose utilizing metabolic endpoints for our Phase III program, which may warrant smaller trials based on improvements in cholesterol and markers of inflammation."

"This trial revealed that A-002 treatment resulted in significant positive changes on lipoproteins and inflammation, major etiological factors that lead to atherosclerosis among cardiovascular patients treated with statins," said Dr. Robert Rosenson, Director of Lipoprotein Disorders and Clinical Atherosclerosis Research at the University of Michigan and lead investigator for the PLASMA trial. "Of particular interest was the marked reduction in small LDL particles that are associated with the development of atherosclerosis."

The company expects to meet with the FDA in December to discuss the results of the trial and plans for Phase III. At present, Anthera anticipates the A-002 Phase III program will target patients with coronary heart disease with associated hyperlipidemia and inflammation who are currently not achieving adequate cholesterol control with diet, exercise, and existing statin therapies such as Lipitor(R). PLASMA-2, the once-daily Phase II trial of A-002, has completed enrollment and data is expected in the first quarter of 2008.

Further information about Anthera's clinical trials can be found at http://www.PLASMAtrial.com or http://www.anthera.com.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases. The Company has acquired from Eli Lilly and Company and Shionogi & Co. Ltd. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase A2 (PLA2) family - a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel upstream steps in the inflammation cascade and have the potential to address a variety of diseases. For more information, please visit http://www.anthera.com.

Contact:

Anne Bowdidge (650) 218-6900

pr@anthera.com


'/>"/>
SOURCE Anthera Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
2. Sygnis Pharma AG announces date for presentation of clinical results
3. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
6. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):