Anthera Completes Enrollment And Dosing Of Varespladib Cardiovascular Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 13 Jan 2009 - 0:00 PDT

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Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced that it has completed enrollment in its 500 patient FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) clinical trial designed to examine the impact of varespladib (A-002) when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event.

"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."

"With the varespladib trial fully enrolled, we look forward to reporting the biomarker results and event trends later this year," said Colin Hislop, M.D., Senior Vice President of Clinical Development at Anthera Pharmaceuticals, Inc. "Based upon the positive results from varespladib's two previous Phase II clinical trials that 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."

Anthera's FRANCIS trial is based upon direct feedback from FDA via the Special Protocol Assessment procedure. The trial is designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk. Anthera plans to enroll between 500-700 patients that will be treated for up to six months. The study is being conducted at sites across North America and Europe. The FRANCIS trial is expected to provide further 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(R) (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. The company has also acquired exclusive and worldwide rights to a peptide fusion protein, A-623, for the treatment of autoimmune diseases from Amgen. For more information, please visit http://www.anthera.com.

Anthera Pharmaceuticals, Inc.
http://www.anthera.com