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
PLASMAtrial or anthera.
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 anthera.
Anthera Pharmaceuticals, Inc.
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