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Phase 2a Findings Demonstrate that CSL112, A Novel Apolipoprotein A-I Infusion Therapy, Has a Favorable Safety Profile, is Well Tolerated and Increases Cholesterol Efflux Capacity in Stable Atherothrombotic Patients
Date:11/20/2013

DALLAS, Nov. 20, 2013 /PRNewswire/ -- Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease.  The trial data for CSL112 also showed a dramatic and rapid increase in key biomarkers of reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance.

"We are encouraged by the positive safety profile observed in the trial which supports progression of the CSL112 clinical development program," said Pierluigi Tricoci, MD, PhD, MHS, Duke Clinical Research Institute, and lead study author. "We know there is a need for novel approaches to reduce the high risk of early recurrent ischemic events after acute coronary syndrome. CSL112 is a promising treatment targeting coronary atherosclerotic plaques causing these events and deserves further investigation."

Three separate analyses of data from the CSL112 Phase 2a study were presented at the American Heart Association 2013 Scientific Sessions. The presentations examined the safety and tolerability, pharmacokinetics and lipid biomarker profile, and potential antiplatelet effects of CSL112 on top of dual antiplatelet therapy.

Study Design and Key Findings
The CSL112 Phase 2a study was a randomized, multicenter, double-blind, placebo-controlled trial (n=44) that evaluated the safety and pharmacokinetics/pharmacodynamics (PK/PD) of a single-dose administration of CSL112 in patients with stable atherothrombotic disease. Patients were randomized to a single infusion of either CSL112 at 1.7, 3.4 or 6.8g doses or masked placebo. PK and PD were assessed up to 7 days after the infusion during the active treatment period. Safety was assessed for up to 90 days after the infusion.            
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