Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular...

Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II
Cardiovascular Trial

SAN MATEO, Calif., Jan. 15 /PRNewswire/ -- Anthera Pharmaceuticals, Inc.,
a privately-held biopharmaceutical company, reported preliminary results of a
second Phase IIb clinical trial of A-002, for the treatment of cardiovascular
disease. In this second study, administration of once-daily A-002 lowered both
sPLA2 and LDL-C levels confirming the positive effects of A-002 treatment seen
in the twice-daily PLASMA study (Phospholipase Levels And Serological Markers
of Atherosclerosis) announced in October 2007.
The second trial was a multi-center, randomized, double-blind, placebo-
controlled trial that enrolled approximately 140 patients with stable coronary
heart disease in the U.S. Subjects were randomized to receive one of two
different daily doses of A-002 or placebo for up to eight weeks. Patients also
received doctor-determined standard of care therapies. The primary endpoint
was reduction in secretory phospholipase A2 (sPLA2) levels. Secondary
endpoints included a number of lipid and inflammatory biomarkers. The Company
plans to present data from the Phase IIb trial at scientific meetings in 2008.
"We are extremely pleased to validate the findings of our first PLASMA
study, with once-a-day dosing of A-002 which further enhances our development
and commercial flexibility," said Paul F. Truex, President and Chief Executive
Officer of Anthera Pharmaceuticals, Inc. "We look forward to meeting with the
FDA to discuss our plans for Phase III. We expect the registration 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)."
Data from the first PLASMA trial demonstrated that in addition to lowering
sPLA2, 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,
oxidized LDL, and apolipoprotein-B100 (Apo-B) coupled with equally meaningful
reductions of C-Reactive Protein (CRP), a recognized marker of inflammation
and possible cardiovascular risk. Decreases in these levels with A-002
treatment were most significant among patients already on a background of
statin therapy.
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.

Anne Bowdidge of Anthera Pharmaceuticals, Inc., +1-650-218-6900,
pr@anthera.com