Sinai Hospital Releases Results Evaluating Antiplatelet Effects of CSL112, A Novel Apolipoprotein A-I Infusion Therapy
Findings of Phase 2a Trial Sponsored by CSL Limited Presented at American Heart Association 2013 Scientific Sessions
Embargo expired: 20-Nov-2013 7:00 AM EST
Source Newsroom: LifeBridge Health
Newswise — Dallas, TX – Researchers from the Sinai Center for Thrombosis Research presented findings from a Phase 2a trial substudy that examined the antiplatelet effects of CSL112, a novel apolipoprotein A-I (apo A-I) infusion therapy, at the American Heart Association 2013 Scientific Sessions.
The Phase 2a study evaluated the safety and pharmacokinetic and pharmacodynamic properties of a single dose of CSL112 in patients with stable atherothrombotic disease on chronic dual antiplatelet therapy. Results presented by Pierluigi Tricoci, MD, PhD, MHS, Duke Clinical Research Institute showed that CSL112 increased apo A-I levels, the active component of HDL and there were no serious adverse events reported.
Further, results presented by Andreas Gille, MD, PhD, CSL Limited showed that 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.
Paul A. Gurbel, MD, Director, Sinai Center for Thrombosis Research at the Sinai Hospital of Baltimore led an important evaluation of platelet function to assess the potential antiplatelet properties of CSL112. In a separate presentation, Gurbel reported that CSL112 did not significantly influence platelet aggregation in response to arachidonic acid, adenosine diphosphate and collagen.
“CSL112 is a promising new treatment for patients with high risk cardiovascular disease,” said Gurbel. “Since CSL112 had no significant influence on platelet aggregation, it is anticipated that patients should not face an increased bleeding risk while receiving this infusion therapy along with concomitant antiplatelet agents.”
CSL112 is a novel formulation of apolipoprotein A-I (apoA-I), the active component of high-density lipoprotein (HDL). It is purified from human plasma and reconstituted to form HDL particles suitable for intravenous infusion. Studies have shown the infusion of
CSL112 rapidly elevates markers of reverse cholesterol efflux, a process by which cholesterol is removed from arteries and transported to the liver for clearance. CSL112 may offer a novel option for rapidly stabilizing atherosclerotic lesions and is being studied for reduction in the risk of early atherothrombotic events in acute coronary syndrome (ACS) patients.
About the Sinai Center for Thrombosis Research
The Sinai Center for Thrombosis Research (SCTR), under the direction of Paul A. Gurbel, MD, is recognized in the international cardiology and thrombosis community as a leader in the field of antithrombotic therapy. The expertise of the lab is centered on anti-platelet drug development, antithrombotic therapy and personalized anti-platelet therapy.
The breakthrough findings of Gurbel and his team at Sinai have been published in hundreds of peer-reviewed medical journal articles and have influenced treatment guidelines related to anti-platelet therapy as recognized by the American Heart Association (AHA), the American College of Cardiology and the European Society of Cardiology. Their research has also created a platform for the discovery of new antithrombotic drugs.
For more information on the Sinai Center for Thrombosis Research, visit www.lifebridgehealth.org/thrombosisresearch
Sinai Hospital is part of LifeBridge Health, one of the largest, most comprehensive providers of health services in northwest Baltimore. In addition to Sinai, it includes Northwest Hospital, Levindale Hebrew Geriatric Center and Hospital, Courtland Gardens Nursing & Rehabilitation Center and related subsidiaries and affiliates. For more information, visit www.lifebridgehealth.org.