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:6/26/2016)... 26, 2016 One of Australia,s ... formation of a new biotechnology company, Noxopharm Limited [ABN 50 608 ... IPO and to list on the ASX. Noxopharm is ... to enter a Phase 1 clinical study later this year. ... one of the biggest problems facing cancer patients - the ability ...
(Date:6/26/2016)... 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ... Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) expired ... Time). As previously announced on May 31, ... merger agreement under which Jazz Pharmaceuticals has commenced a ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
Breaking Medicine Technology:
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can now ... and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings ... The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Scientific Sessions in Dallas that it will receive two significant new grants to ... came as PHA marked its 25th anniversary by recognizing patients, medical professionals and ...
Breaking Medicine News(10 mins):