SAN MATEO, Calif., Aug. 25 Anthera Pharmaceuticals Inc., aprivately held biopharmaceutical company developing anti-inflammatory drugs,today announced the initiation of the FRANCIS (Fewer Recurrent Acute coronaryevents with Near-term Cardiovascular Inflammation Suppression) clinical trialdesigned to examine the impact of varespladib when administered to patientswithin 96 hours of an Acute Coronary Syndrome (ACS) event.
The FRANCIS trial is designed to assess the impact of oral varespladib onknown biological markers of cardiovascular risk. It will enroll up to 500patients that will be treated for a minimum of six months. The study will beconducted at sites in North America and Europe. FRANCIS will provide insightinto the prevention of secondary Major Adverse Cardiovascular Events (MACE)over the duration of the trial. In this study, MACE is defined as a compositeendpoint consisting of cardiovascular death, non-fatal stroke, non-fatalmyocardial infarction, unstable angina, and a subset of revascularizationfollowing the initial event. During the course of the study, patients willreceive therapeutic standard of care in addition to high dose Lipitor(R)(atorvastatin). In previous clinical trials, varespladib, a potent and highlyselective inhibitor of secretory phospholipase A2 (sPLA2), has demonstratedmarked improvements in independent markers of cardiovascular risk including, anear complete suppression of the target enzyme sPLA2, a clinically meaningfuland statistically significant reduction in "bad" LDL cholesterol, and areduction in C-reactive protein, a known marker of inflammation.
"We are pleased with the continued progress of our varespladibcardiovascular program targeting secretory phospholipase A2," said Paul Truex,President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "TheFRANCIS trial was designed with input from global regulatory agencies andindustry experts and represents the next key component of our internationalcardiovascular development program. The multiple therapeutic impact ofvarespladib's mechanism of action provides us with a unique opportunity todevelop a first-in-class product targeting a life-threatening coronary eventfor which there are limited therapeutic options."
"Based upon the success of varespladib in two previous Phase II clinicaltrials in patients with cardiovascular disease in which it demonstratedlipid-lowering and anti-inflammatory benefits, we look forward to furtherevaluating the impact of varespladib on the hyper-inflammatory state presentedby ACS patients," said Dr. James Pennington, Executive Vice President andChief Medical Officer of Anthera Pharmaceuticals, Inc.
About Acute Coronary Syndrome
Acute coronary syndrome is a heart condition characterized by chest painoccurring at rest or upon minimal exertion. This condition is also referred toas unstable angina. If the chest pain is associated with heart muscle damageand heart tracing abnormalities, it is typically classified as a heart attackor myocardial infarction.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately-held company committed todeveloping and commercializing clinical pharmaceutical products that addressunmet medical needs of patients with life-threatening, chronic and acuteinflammatory diseases and autoimmune disorders. The Company has acquired fromEli Lilly and Company and Shionogi & Co.‚ Ltd. worldwide rights (excludingJapan) to a series of clinical and pre-clinical compounds that inhibit theenzymatic activity of members of the phospholipase (PLA2) family -- a group ofenzymes responsible for the release of arachidonic acid and subsequentproduction of leukotrienes‚ prostacyclins and other mediators of inflammation.These highly potent compounds inhibit novel‚ upstream steps in theinflammation cascade and have the potential to address a variety of diseases.The company has a