News Article
Isotechnika partner invited to present on drug eluting stent trial using voclosporin
10/16/2008 11:05 AM - Canada NewsWire
EDMONTON, Oct. 16, 2008 (Canada NewsWire via COMTEX News Network) --
(ISA:TSX):Isotechnika Inc. today announced that its medical device partner,Atrium Medical Corporation, presented new data on its drug elutingcoronary stent. Atrium presented the protocol design for its CONFIRM 1trial, a First-in-Man trial of its CINATRA(TM) product, a drug elutingcoronary stent coated with voclosporin. Atrium reported that the trialhas enrolled 69 of its targeted 100 patients at seven sites in Belgium,and the Company expects to complete enrollment by the end of 2008. Datacollected thus far were presented at the 20th Annual TranscatherCardiovascular Therapeutics (TCT) Conference held in Washington, DCfrom October 12th to 17th. Isotechnika licensed voclosporin to AtriumMedical in 2005 for the exclusive use with implantable medical devices.
"Atrium's CONFIRM 1 trial further validates the multipleapplications of our proprietary voclosporin compound. Voclosporin wasselected by Atrium to be combined with its CINATRA(TM) coronary stentsystem for its desirable anti-inflammatory properties in the vascularsystem," said Dr. Robert Foster, Chief Executive Officer ofIsotechnika. "Atrium expects to file for CE mark approval in the EU forCINATRA(TM) as early as the fourth quarter of 2010. The worldwidemarket for these stents is estimated to be $4 billion."
"Interventionalcardiologists have been waiting for a new technology that delivers theeffectiveness of a drug eluting stent with a safer, more natural,non-polymeric coating platform," said Trevor Carlton, President ofAtrium Medical Corporation. "By combining the benefits of our patentedOmega 3 coating platform with Isotechnika's novel drug compoundvoclosporin, CINATRA(TM) represents a novel treatment options forpatients requiring a drug eluting coronary stent. This combination hasthe potential to result in a better healed implant shortly afterimplantation."
CONFIRM 1 trial is a First-in-Man, prospective,multi-center, single blind, randomized, controlled study using theCINATRA(TM) voclosporin coated coronary stent system, which will becompared to Atrium's CINATRA(TM) bare metal coronary stent (BMS)platform. The study will enroll 100 patients and will be conducted atseven hospitals in Belgium with Glenn Van Langenhove, MD, PhD ofMiddelheim Hospital, Antwerp, serving as the study's principalinvestigator. The primary endpoint of the trial is to evaluate thesafety and performance of the CINATRA(TM) voclosporin coated coronarystent system compared to the CINATRA BMS coronary stent system inpatients with de novo coronary artery disease. Patient outcomes, inaddition to drug coated stent performance, will be assessed bymeasuring Late Lumen Loss at six months following implantation.
Aspart of its presentation, Atrium also released preclinical data from aporcine animal model demonstrating a reduction in inflammation in theCINATRA arm for each of the three voclosporin dose groups relative tothe other control groups. A reduction in neointima was also observed,likely related to inflammation reduction. No safety issues wereobserved in any dose group. For additional information on the 20thAnnual TCT conference please visit https://www.tctconference.com/.