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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

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No treatment-emergent serious adverse events (AE) were reported during the active treatment period except for one case of atrial fibrillation which occurred in the placebo group.  Assessments of liver function and other key biochemical, hematologic and immunogenic measurements over time were similar across all CSL112 and placebo groups.

PK and PD analyses showed that CSL112 caused immediate and robust increases in apoA-I, the active component of high density lipoprotein (HDL). Blood levels of apoA-I rose in a dose-proportional fashion with elevations approaching three-fold baseline levels at the top dose.  The highly anti-atherosclerotic form of HDL known as PreBeta1 showed an even greater elevation, with increases up to 17-fold. CSL112 also enhanced key biomarkers of the early steps of reverse cholesterol transport with strong elevations in cholesterol efflux capacity observed across all CSL112 regimens.  Changes were maintained for up to 72 hours after infusion of CSL112 at the higher doses.

Potential antiplatelet effects of CSL112 were also evaluated in this population of patients who were receiving chronic dual antiplatelet therapy.  CSL112 did not significantly influence platelet aggregation in response to AA, ADP and collagen. Based on these data, it is anticipated that CSL112 will not affect hemostasis when administered with concomitant antiplatelet therapies.

"Patients who experience an ACS event have a great unmet need to reduce the risk of suffering another heart attack, stroke or other cardiovascular event, particularly within the first 30 days," said Chuck Shear, CSL Cardiovascular Therapeutic Area Head. "The results of this third clinical stu
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SOURCE CSL Limited
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