January 4‚ 2007
Anthera Receives FDA Approval to begin phase 2 “PLASMA” trial with A-002 For patients with coronary atherosclerosis
San Mateo‚ CA – January 4‚ 2007 – Anthera Pharmaceuticals‚ Inc.‚ a privately held
biopharmaceutical company developing anti-inflammatory drugs for chronic and acute diseases‚ announced today that the
US Food and Drug Administration has approved its Investigational New Drug (IND) application for its lead cardiovascular
compound A-002. As a result of this approval, Anthera will initiate a multi-center phase 2 clinical trial
(PLASMA – Phospholipase Levels And Serological Markers of Atherosclerosis) that will examine the effect of A-002
on secretory phospholipase 
(
) levels and other well established markers of inflammation and cardiovascular
risk in patients with stable coronary artery disease due to underlying atherosclerosis. PLASMA is expected to
complete enrollment by the fourth quarter of 2007.
is a family of enzymes that hydrolyze phospholipids leading to a chronic inflammatory response and harmful changes
to serum lipid profiles. A-002 represents the first product in a class of compounds aimed at suppressing the activity of .
Recent animal data regarding A-002’s impact on atherosclerosis‚ lipids‚ and inflammation will be presented at the 8th Congress on
Inflammation in Copenhagen‚ Denmark‚ June 16th‚ 2007.
“The clinical burden of cardiovascular disease is large and will continue to grow over the coming decades. PLASMA is our first step on a path to provide a new option for patients who remain in need of more advanced therapies to treat their underlying vascular disease‚” stated Colin Hislop MD‚ Senior Vice President Clinical Development. “With increasing focus on chronic inflammation in patients with atherosclerosis‚ A-002 provides a potential new therapeutic approach to suppress inflammation‚ improve lipid profiles‚ and hopefully improve patient outcomes.”
According to the American Heart Association‚ coronary heart disease affects nearly 14 million people in the United States and
more than 30 million worldwide. Atherosclerosis is a disease of the arteries that results from inflammation and the build-up of
plaque under the lining of the blood vessel. This build-up can cause vascular swelling and eventual rupture. levels have
been shown to be elevated in patients with both stable and unstable coronary artery disease. Higher levels of the enzyme have
been shown to predict an increased risk for future cardiovascular events such as heart attacks and stroke.
“PLASMA is intended to determine whether inhibition of sPLA2‚ an important trigger of the inflammatory response‚ can reduce
systemic levels of inflammatory markers known to be predictors of coronary heart disease events. This study will serve as a
basis for future trials that investigate the effects of inhibition on atherosclerosis progression and cardiovascular
events‚” stated Robert S. Rosenson‚ M.D.‚ Professor of Medicine and Director‚ Lipoprotein Disorders and Clinical
Atherosclerosis Research‚ Division of Cardiovascular Medicine at the University of Michigan and the Principal
Investigator for the PLASMA trial.
Further information about this clinical trial and atherosclerosis can be found at the PLASMA Trial Site or www.anthera.com.
Anthera will develop the program’s lead compound A–001 as an early intervention therapy for acute pulmonary diseases such as
acute chest syndrome in patients with underlying sickle cell disease. Worldwide‚ nearly 200‚000 suffer from some form of this genetic
blood disorder which results in an estimated 60‚000 hospitalizations per year and significantly reduces life expectancy. Acute chest
syndrome is a severe respiratory complication of sickle cell disease and is the leading cause of death in patients with this life
threatening genetic disorder. Recent academic clinical studies in sickle cell patients have demonstrated that serum levels
rise in advance of the acute chest syndrome‚ creating a unique opportunity for early intervention.
A–001 is a novel potent inhibitor of secretory phospholipase – a group of enzymes responsible for triggering the release of
arachidonic acid and subsequently the production of leukotrienes and prostacyclins and other mediators of inflammation. In various animal
and in vitro studies it has been demonstrated that activity results in the release of several highly reactive mediators that promote
and/or amplify inflammation. In several preclinical and clinical studies levels correlated with inflammatory response. Elevated
levels of have been reported in several body fluids (e.g.‚ serum‚ synovial fluid‚ and bronchoalveolar lavage fluid) from humans
with several inflammatory conditions including rheumatoid arthritis‚ asthma‚ coronary artery disease (atherosclerosis)‚ lung injury
and dermatitis.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately-held pharmaceutical development company committed to world-class development and commercialization of promising clinical products to address the
unmet medical needs of patients with life-threatening chronic and acute inflammatory diseases. In 2006‚ Anthera acquired worldwide rights (except Japan) to a series of clinical and pre–clinical
compounds that inhibit the enzymatic activity of members of the phospholipase (
) 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 including: acute chest syndrome‚ acute lung injury‚ acute respiratory distress syndrome‚ atherosclerosis‚ acute coronary syndrome‚ chronic obstructive pulmonary disease and psoriasis. In
order to efficiently commercialize this platform‚ Anthera has brought together a proven management team with extensive experience in licensing‚ clinical research‚ development‚ and commercialization
of anti-inflammatory products.
CONTACT:
Press Relations
510-277-1208
PR@anthera.com
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