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:4/20/2017)... , April 20, 2017 Research and Markets ... - Innovation Driven by Rapidly Expanding Injectables Market and Increasing Usage ... offering. ... drug delivery technologies will rise from USD 20 Billion in 2015 ... Global Drug Delivery Technologies - Innovation Driven by Rapidly Expanding Injectables ...
(Date:4/20/2017)...  AbbVie (NYSE: ABBV), a global biopharmaceutical company, ... hepatitis C virus (HCV) infected patients with genotype ... cirrhosis (Child-Pugh A) achieved sustained virologic response at ... investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). These high ... weeks of G/P treatment without ribavirin. Patients with ...
(Date:4/20/2017)... LUND, Sweden , April 20, 2017 /PRNewswire/ ... OTCQX: NEVPF) ("NeuroVive") today announced positive preclinical ... company,s preclinical compound for non-alcoholic steatohepatitis (NASH), ... NV556 has previously ... STAM™ NASH model. Today, NeuroVive,s scientists present ...
Breaking Medicine Technology:
(Date:4/28/2017)... Olathe, KS (PRWEB) , ... April 28, 2017 ... ... system have typically been previously exposed to more adverse experiences than children in ... have experienced trauma such as abuse, neglect or other family challenges. While no ...
(Date:4/28/2017)... ... April 28, 2017 , ... Early ... substantially improve drug safety and minimize the cost of development. In this webinar, ... inhibition using cell lines and for cardiac toxicity using induced pluripotent stem cells ...
(Date:4/28/2017)... ... April 28, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of ... the Creator responds to and which He does not. Yisrayl says with so many ... is the true name, but he says with a little Scripture, backed with a lot ...
(Date:4/28/2017)... ... 2017 , ... Intellitec Solutions announced the publication of a ... Dynamics GP solution that integrates to their PointClickCare EHR software package. With the ... Brooke Grove now has the capability to achieve its goal for a comprehensive ...
(Date:4/28/2017)... ... April 28, 2017 , ... Rob Lowe is a popular actor that ... his presence to an educational purpose as the host of the “Informed” series. The ... In a recent episode, the series focuses on thyroid cancer. , Although thyroid cancer ...
Breaking Medicine News(10 mins):