VOCLOSPORIN COATED CORONARY STENT IMPLANTED IN FIRST PATIENT
EDMONTON, Jun 11, 2008 (Canada NewsWire via COMTEX News Network) --
Isotechnika Inc. announced today that its partner, Atrium Medical Corporation has begun enrollment for their CONFIRM 1, First-in-Man (FIM) drug eluting coronary stent clinical trial evaluating Atrium's CINATRA(TM) voclosporin coated coronary stent system.
This First-in-Man trial is a prospective, multi-center, single blind, randomized, controlled study using the CINATRA(TM) voclosporin coated coronary stent system, which will be compared to Atrium's CINATRA(TM) bare metal coronary stent (BMS) platform. This first use study of voclosporin on an implantable medical device will enroll 100 patients, and will be conducted at seven hospitals in Belgium with Glenn Van Langenhove, MD, PhD of Middelheim Hospital, Antwerp, as the study's Principal Investigator. The primary endpoint of the trial is to evaluate the safety and performance of the CINATRA(TM) voclosporin coated coronary stent system in patients with de novo coronary artery disease. Patient outcomes, in addition to drug coated stent performance, will be assessed by measuring Late Lumen Loss, in-stent and in-segment lumen loss measurements at six months following implantation.
"After many years of pre-clinical testing, Atrium is very excited to be able to study the new CINATRA(TM) coronary stent platform with voclosporin, a promising new drug, and the company's all natural O3FA coating technology that merges the desirable safety benefits of a bare metal stent with the clinical advantages of a bio-absorbable Omega 3 fatty acid coating," stated Trevor Carlton, Atrium's Medical Corporation President. "Use of Atrium's patented Omega 3 coating platform, together with its novel drug compound has created a new class of patient treatment options that require a drug eluting coronary stent. Interventional cardiologists and patients alike have been waiting for a new technology that delivers the effectiveness of a drug eluting stent with a safer, more natural, non-polymer coating platform resulting in a well healed implant shortly after insertion."
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.
About Isotechnika Inc.
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Edmonton-based Isotechnika Inc. is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential will exceed $4 billion annually in sales for calcineurin inhibitors such as voclosporin by 2010.
Voclosporin is a next generation calcineurin inhibitor, which recently completed a Phase 2b North American trial for the prevention of kidney rejection following transplantation. An extension to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis are ongoing. Our partner, Lux Biosciences, is currently conducting three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LX211 by Lux) for the treatment of uveitis.
Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika can be found at www.isotechnika.com.
About Atrium
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Atrium's vast expertise in medical device technologies for the treatment of cardiovascular disease, hernia and adhesion prevention has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and soft tissue repair. Maintaining a commitment to the latest ISO13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in those healthcare segments that require more advanced surgical intervention for improvements in patient outcome. For more information, call 800-370-7899 or visit www.atriummed.com.
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