EDMONTON, May 29 /CNW/ - Isotechnika Inc. announced today that voclosporin is positioned to enter a Phase 1 clinical trial as the drug utilized in the CINATRA(TM) Drug Coated Coronary Stent system developed by the Company's partner, Atrium Medical Corporation. Atrium has received approval from the Belgian Competent Authority to commence the trial.
This First-in-Man trial is a prospective, multi-centre, single blind, randomized, controlled clinical trial of the CINATRA(TM) Voclosporin Coated Coronary Stent System as compared to the bare metal CINATRA(TM) Coronary Stent System. The trial is expected to involve up to 100 patients and will be conducted at seven clinical trial sites in Belgium with Glenn Van Langenhove, MD, PhD of Middelheim Hospital Antwerp as Principal Investigator. The primary endpoint of the trial is to evaluate the safety and performance of the CINATRA(TM) Voclosporin Coated Coronary Stent System and the CINATRA(TM) Coronary Stent System in patients with de novo coronary artery disease. The performance will be assessed by measuring the Late Lumen Loss, in-stent and in-segment at six months post procedure.
Trevor Carlton, Atrium's President, commented, "We are extremely excited to be able to test our new CINATRA(TM) stent platform, voclosporin and our proprietary O3FA coating technology that merges the desirable safety benefits of a bare metal stent with the clinical advantages of a drug eluting stent creating a new class of patient treatment options. Interventional cardiologists and patients alike have been waiting for a technology that delivers the effectiveness of a new drug and coating platform that leaves a safe bare metal stent in place after a short period of time in the body."
"Having voclosporin set to commence clinical trials in another application is an exciting opportunity for the company," stated Dr. Robert Foster, Isotechnika's Chairman & CEO.
About CINATRA(TM) Voclosporin Coated Coronary Stent System
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The CINATRA(TM) Voclosporin Coated Coronary Stent System is comprised of a cobalt chromium bare metal stent mounted on a delivery balloon catheter. The stent and the balloon are coated with Atrium's proprietary Omega-3 fatty acid coating technology utilizing voclosporin for its anti-inflammatory properties.
