Healthcare Industry News: Balloon catheter
News Release - January 22, 2009
Isotechnika Announces Full Enrollment Achieved in Partner Atrium's CONFIRM 1 Trial for Voclosporin Coated Coronary Stent System
EDMONTON, Jan. 22 - (HSMN NewsFeed) - (ISA:TSX): Isotechnika Inc. announced today that its partner, Atrium Medical Corporation has completed patient enrollment for their CONFIRM 1, First-in-Man (FIM) drug coated coronary stent clinical trial evaluating Atrium's CINATRATM voclosporin coated coronary stent system.This FIM trial is a prospective, multi-center, single blind, randomized, controlled study using the CINATRATM voclosporin coated coronary stent system, which will be compared to Atrium's CINATRATM bare metal coronary stent (BMS) platform. This first use study of voclosporin on an implantable medical device enrolled 100 patients and is currently being 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 CINATRATM 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.
"We are extremely pleased to have completed enrollment within our projected timelines," said Trevor Carlton, Atrium's President. "Our last patient is expected to have their six month follow-up procedure at the end of June 2009 with results available in the third quarter of this year."
"The progress that Atrium has been able to achieve in such a short period of time is extremely exciting," stated Dr. Robert Foster, Isotechnika's Chief Executive Officer. "We look forward to sharing the results with both the scientific and investment communities later this year."
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
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 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 LUVENIQTM by Lux) for the treatment of uveitis. Voclosporin has also entered First-in-Man trials as the drug utilized in the CINATRA(TM) Drug Coated Coronary Stent system developed by our partner, Atrium Medical Corporation.
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/ or www.SEDAR.com.
Forward-Looking Statements
This press release may contain 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, the availability of funds and resources to pursue research and development projects, 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, 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. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward- looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
Source: Isotechnika
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