Navigation Links
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.                                                    

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 study of CSL112 support our continued enthusiasm for its development as a novel approach to address this important therapeutic void."

About CSL112
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 CSL
Headquartered in Melbourne, Australia, CSL Limited is a global biopharmaceutical company that develops, manufactures and markets biotherapies to prevent and treat rare and serious human diseases. CSL owns major facilities in Australia, Germany, Switzerland and the United States, and employs over 11,000 people in more than 25 countries. Visit www.csl.com.au for more information.

Contact

Sheila A. Burke
Director, Communications & Public Relations
Worldwide Commercial Operations
CSL Behring
C: 484-919-2618
Sheila.Burke@cslbehring.com

Eliot Harrison
MCS Healthcare Public Relations
C: 908-884-5252
eharrison@mcspr.com


'/>"/>
SOURCE CSL Limited
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Topokine Commences Phase 2 Clinical Trial of XAF5 Gel to Reduce Submental Fat
2. Amgen Presents Interim Overall Survival Data From Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic Melanoma
3. Surprise: Viruses Can Cause Disease during Latent Phase; New Evidence Supports Microcompetition Theory
4. RXi Pharmaceuticals Announces the Start of Their First Phase 2 Study with RXI-109 for Treatment of Hypertrophic Scars in Conjunction with Scar Revision Surgery
5. Omeros to Present Data from OMS302 Phase 3 Clinical Program at the American Academy of Ophthalmology Annual Meeting
6. GW Pharmaceuticals Commences Phase 1b/2a Clinical Trial for the Treatment of Glioblastoma Multiforme (GBM)
7. Pfenex Inc. Awards Paragon Bioservices a Contract for cGMP Manufacturing of its Recombinant Protective Antigen (rPA), for Phase 1 Clinical Trial of its Anthrax Vaccine
8. Cellular Biomedicine Group Announces Completion of Patient Treatment for Phase I/IIa Clinical Trial for Treatment of Knee Osteoarthritis (KOA)
9. KemPharm Completes Successful End-of-Phase 2 Meeting with FDA
10. Polaris Group Announces Positive Results for Phase 2 Study of ADI-PEG 20 in Malignant Pleural Mesothelioma
11. Xencors XmAb5871 Enters Phase 2a Study for Autoimmune Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... PHILADELPHIA , June 27, 2016  Liquid ... today announced the funding of a Sponsored Research ... study circulating tumor cells (CTCs) from cancer patients.  ... changes in CTC levels correlate with clinical outcomes ... therapies. These data will then be employed to ...
(Date:6/24/2016)... ... 24, 2016 , ... While the majority of commercial spectrophotometers and fluorometers use ... 6000i models are higher end machines that use the more unconventional z-dimension of 20mm. ... from the bottom of the cuvette holder. , FireflySci has developed several Agilent ...
(Date:6/23/2016)... CAMBRIDGE, Mass. , June 23, 2016 /PRNewswire/ ... the development of novel compounds designed to target ... compound, napabucasin, has been granted Orphan Drug Designation ... in the treatment of gastric cancer, including gastroesophageal ... cancer stemness inhibitor designed to inhibit cancer stemness ...
(Date:6/23/2016)... ... 23, 2016 , ... Charm Sciences, Inc. is pleased to ... AOAC Research Institute approval 061601. , “This is another AOAC-RI approval of the ... Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods perform comparably ...
Breaking Biology Technology:
(Date:6/2/2016)... The Department of Transport Management (DOTM) ... million US Dollar project, for the , Supply ... Enrolment, and IT Infrastructure , to ... implementation of Identity Management Solutions. Numerous renowned international vendors participated ... was selected for the most compliant and innovative ...
(Date:6/1/2016)... 1, 2016 Favorable Government Initiatives ... and Criminal Identification to Boost Global Biometrics System Market ... TechSci Research report, " Global Biometrics Market By ... and Opportunities, 2011 - 2021", the global biometrics market ... on account of growing security concerns across various end ...
(Date:5/16/2016)... 2016   EyeLock LLC , a market leader ... of an IoT Center of Excellence in ... development of embedded iris biometric applications. EyeLock,s ... and security with unmatched biometric accuracy, making it the ... DNA. EyeLock,s platform uses video technology to deliver a ...
Breaking Biology News(10 mins):