Anthera Received USFDA Approval to Initiate A-002 Phase 2 'PLASMA' Trial in Patients with Coronary Atherosclerosis
The USFDA has approved Anthera Pharmaceuticals, Inc.’s Investigational New Drug (IND) application for its lead cardiovascular compound A-002.
The said approval enables the company to proceed with its multi-center phase 2 clinical trial (PLASMA -- Phospholipase Levels And Serological Markers of Atherosclerosis) designed to examine the effect of A-002 on secretory phospholipase A2 (sPLA2) levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease due to underlying atherosclerosis.
sPLA2 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 sPLA2.
PLASMA is expected to complete enrollment by the fourth quarter of 2007.
Find more details from the Anthera press release.
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