ANTHERA ANNOUNCES ENROLLMENT OF 500TH PATIENT IN FRANCIS TRIAL OF A-002 FOR THE TREATMENT OF CARDIOVASCULAR DISEASEHAYWARD, CA – January 12, 2009
– Anthera Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing anti-inflammatory drugs, announced today the enrollment of its 500th
patient in its FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) clinical trial designed to examine the impact of varespladib when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event. A pre-defined biomarker analysis is scheduled to be completed in the second quarter of 2009, followed by an event trends analysis later in the year.
“We are pleased with the continued progress of our varespladib cardiovascular program targeting secretory phospholipase A2,” said Paul Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. “The multiple therapeutic impact of varespladib’s mechanism of action provides us with a unique opportunity to develop a first-in-class product targeting a life-threatening coronary event for which there are limited therapeutic options.”
“We are pleased with the rapid enrollment of this study and look forward to reporting the biomarker results and event trends later this year,” said Colin Hislop, M.D., Senior Vice President Clinical Development at Anthera Pharmaceuticals. “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 examining the impact of varespladib on the hyper-inflammatory state presented by ACS patients.”
The FRANCIS trial is based upon direct feedback from FDA via the Special Protocol Assessment procedure. FRANCIS is designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk. It will enroll a minimum of 500 patients and a maximum of 700 patients that will be treated for up to six months. The study is being conducted at sites in North America and Europe. FRANCIS will provide insight into the prevention of secondary Major Adverse Cardiovascular Events (MACE) over the duration of the trial. In this study, MACE is defined as a composite endpoint consisting of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a subset of revascularization following the initial event. During the course of the study, patients will receive therapeutic standard of care in addition to high dose Lipitor® (atorvastatin). In previous clinical trials, varespladib, a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2), has demonstrated marked improvements in independent markers of cardiovascular risk including a near complete suppression of the target enzyme sPLA2, a clinically meaningful and statistically significant reduction in “bad” LDL cholesterol, and a reduction in C-reactive protein, a known marker of inflammation.
About Acute Coronary Syndrome
Acute coronary syndrome is a heart condition characterized by chest pain occurring at rest or upon minimal exertion. This condition is also referred to as unstable angina. If the chest pain is associated with heart muscle damage and heart tracing abnormalities, it is typically classified as a heart attack or myocardial infarction.
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 and autoimmune disorders. 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 (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 www.anthera.com
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