Isotechnika Partner Invited to Present on Drug Eluting Stent Trial Using Voclosporin
EDMONTON, Alberta – October 16, 2008 (ISA:TSX): Isotechnika Inc. today announced that its medical device partner, Atrium Medical Corporation, presented new data on its drug eluting coronary stent. Atrium presented the protocol design for its CONFIRM 1 trial, a First-in-Man trial of its CINATRA™ product, a drug eluting coronary stent coated with voclosporin. Atrium reported that the trial has enrolled 69 of its targeted 100 patients at seven sites in Belgium, and the Company expects to complete enrollment by the end of 2008. Data collected thus far were presented at the 20th Annual Transcather Cardiovascular Therapeutics (TCT) Conference held in Washington, DC from October 12th to 17th. Isotechnika licensed voclosporin to Atrium Medical in 2005 for the exclusive use with implantable medical devices.
“Atrium’s CONFIRM 1 trial further validates the multiple applications of our proprietary voclosporin compound. Voclosporin was selected by Atrium to be combined with its CINATRATM coronary stent system for its desirable anti-inflammatory properties in the vascular system,” said Dr. Robert Foster, Chief Executive Officer of Isotechnika. “Atrium expects to file for CE mark approval in the EU for CINATRATM as early as the fourth quarter of 2010. The worldwide market for these stents is estimated to be $4 billion.”
“Interventional cardiologists have been waiting for a new technology that delivers the effectiveness of a drug eluting stent with a safer, more natural, non-polymeric coating platform,” said Trevor Carlton, President of Atrium Medical Corporation. “By combining the benefits of our patented Omega 3 coating platform with Isotechnika’s novel drug compound voclosporin, CINATRATM represents a novel treatment options for patients requiring a drug eluting coronary stent. This combination has the potential to result in a better healed implant shortly after implantation.”
CONFIRM 1 trial is a First-in-Man, 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. The study will enroll 100 patients and will be conducted at seven hospitals in Belgium with Glenn Van Langenhove, MD, PhD of Middelheim Hospital, Antwerp, serving 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 compared to the CINATRA BMS 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 at six months following implantation.
As part of its presentation, Atrium also released preclinical data from a porcine animal model demonstrating a reduction in inflammation in the CINATRA arm for each of the three voclosporin dose groups relative to the other control groups. A reduction in neointima was also observed, likely related to inflammation reduction. No safety issues were observed in any dose group. For additional information on the 20th Annual TCT conference please visit http://www.tctconference.com/.
For more information: Stephanie Gillis-Paulgaard Director, Corporate Communications Isotechnika Inc. Phone:780-909-4661 Fax:780-484-4105 E-mail:firstname.lastname@example.org
Posted: October 2008