Drug-Eluting Coronary Stents Utilizing Isotechnika's Lead Drug Receive Approval to Enter Clinical Trials
Edmonton, Canada (ots/PRNewswire)
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
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.
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 CAD$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 http://www.isotechnika.com.
About Atrium
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 http://www.atriummed.com.
Forward-Looking Statements
This press release may contain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Forward-looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, securing and maintaining corporate alliances, the need for additional capital and the effect of capital market conditions and other factors on capital availability, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, competition, the ability of the Company to defend its patents from infringement by third parties, and the risk that the Company's patents may be subsequently shown to be invalid or infringe the patents of others. Additional risks and uncertainties relating to the Company and its business can be found in the "Risk Factors" section of the Company's Annual Information Form. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements.
For further information:
Dr. Robert Foster
Chairman & CEO
Isotechnika Inc.,
Phone: +1-780-487-1600 Ext.272
Fax: +1-780-484-4105
Email: rfoster@isotechnika.com
Stephanie Gillis-Paulgaard
Director
Corporate Communications
Isotechnika Inc.
Phone: +1-780-487-1600 Ext. 243
Fax: +1-780-484-4105
E-mail:sgillis-paulgaard@isotechnika.comContact:
For further information: Dr. Robert Foster, Chairman & CEO,
Isotechnika Inc., Phone: +1-780-487-1600 Ext.272, Fax:
+1-780-484-4105, Email: rfoster@isotechnika.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-780-487-1600 Ext. 243, Fax: +1-780-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com