�Anthera Pharmaceuticals
Inc., a privately held biopharmaceutical company developing
anti-inflammatory drug drugs, announced the installation of the FRANCIS
(Fewer Recurrent Acute coronary events with Near-term Cardiovascular
Inflammation Suppression) clinical trial designed to analyse the encroachment of
varespladib when administered to patients within 96 hours of an Acute
Coronary Syndrome (ACS) event.
The FRANCIS trial is designed to assess the impact of oral varespladib
on known biological markers of cardiovascular risk. It will enroll up to
500 patients that volition be treated for a minimum of six months. The survey
will be conducted at sites in North America and Europe. FRANCIS testament
provide insight into the prevention of secondary Major Adverse
Cardiovascular Events (MACE) over the duration of the test. In this study,
MACE is defined as a composite termination consisting of cardiovascular expiry,
non-fatal cam stroke, non-fatal myocardial infarction, unstable angina, and a
subset of revascularization following the initial upshot. During the course
of the study, patients volition receive therapeutic standard of care in
addition to high dosage Lipitor(R) (atorvastatin). In previous clinical
trials, varespladib, a potent and highly selective inhibitor of secretory
phospholipase A2 (sPLA2), has demonstrated marked improvements in
sovereign markers of cardiovascular risk including, a near complete
suppression of the target enzyme sPLA2, a clinically meaningful and
statistically meaning reduction in "bad" LDL cholesterol, and a
reduction in C-reactive protein, a known mark of inflammation.
"We are pleased with the continued progress of our varespladib
cardiovascular platform targeting secretory phospholipase A2," said Paul
Truex, President and Chief Executive Officer of Anthera Pharmaceuticals,
Inc. "The FRANCIS trial was designed with input from global regulative
agencies and industry experts and represents the following key constituent of our
international cardiovascular development programme. The multiple therapeutic
impact of varespladib's mechanism of action provides us with a unique
opportunity to develop a first-in-class merchandise targeting a
life-threatening coronary thrombosis event for which thither are limited therapeutic
options."
"Based upon the success of varespladib in two previous Phase II
clinical trials in patients with cardiovascular disease in which it
demonstrated lipid-lowering and anti-inflammatory benefits, we look forward
to further evaluating the impact of varespladib on the hyper-inflammatory
state presented by ACS patients," said Dr. James Pennington, Executive Vice
President and Chief Medical Officer of Anthera Pharmaceuticals, Inc.
About Acute Coronary Syndrome
Acute coronary thrombosis syndrome is a spunk condition characterized by pectus
pain occurring at lie or upon minimal effort. This condition is likewise
referred to as mentally ill angina. If the chest pain is associated with heart
muscleman damage and heart trace abnormalities, it is typically classified
as a heart attack or myocardial infarction.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately-held party committed to
developing and commercializing clinical pharmaceutical products that
address unmet medical needs of patients with life-threatening, inveterate and
acute inflammatory diseases and autoimmune disorders.
Anthera Pharmaceuticals Inc.
http://www.anthera.com
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