The NOBORI 1 clinical trial will compare the NoboriTM biolimus A9-eluting coronary stent system with Taxus™, Boston Scientific's paclitaxel eluting stent system. The primary endpoint will be in-stent late loss (a measurement of the re-narrowing of the vessel caused by tissue re-growth inside the stent) at nine months. The NOBORI 1 study plans to enroll approximately 400 patients in up to 30 centers in Europe, Australia and Asia through a prospective randomized (2:1) clinical trial. The enrollment is expected to start at the beginning of the second quarter of 2005.
"The initiation of the NOBORI 1 clinical trial represents a significant milestone for our organization," said Yutaro Shintaku, Terumo Interventional Systems, "It demonstrates our ambition to become a respected player in interventional cardiology, one of the fastest growing areas in medical technology."
"I am very excited to lead this clinical program evaluating the new generation of drug eluting stents with biodegradable polymer and drug specifically designed for local application", said Bernard Chevalier, M.D., Centre Cardiologique Nord, Paris, France, principal investigator of NOBORI 1.
In October 2003, Terumo Corporation and Biosensors International, through its Netherlands-based affiliate, Occam International, signed a licensing agreement on drug eluting stent development and marketing. This alliance is effective worldwide, excluding the U.S.A.
The Nobori™ drug eluting stent system uses Biosensors' bare-metal S-Stent as its platform. The system offers a flexible configuration designed to fit even smaller and tortuous blood vessels. S-Stent is an approved product distributed in Asia and Europe.
The Nobori™ system is coated with biodegradable polymer and polylactic acid (PLA), and impregnated with biolimus A9. Biolimus A9 is an anti-proliferative drug specifically developed for local application and formulated to inhibit excessive tissue formation around the stent following implantation.
The drug/polymer matrix is primarily coated on the ablumenal (outside) surfaces of the stent struts. Immediately after stent implantation, the drug begins to be released from the polymer matrix and, due to the high concentration gradient, goes predominantly into the vessel wall. The PLA is resorbed into the tissue, metabolized and excreted by the body as carbon dioxide and water.
Biolimus A9 is proprietary to Biosensors and is being evaluated in STEALTH clinical trials of its BioMatrix™ stent system. The STEALTH trial (first-in-man experience of the biolimus A9 Drug Eluting Stent in Treatment of De Novo Coronary Artery Lesions) enrolled 120 patients in Germany and Brazil in a two arms study, comparing biolimus A9 eluting stents to bare metal S-Stents.
At six months, STEALTH summarized results of angiographic analysis indicated lower restenosis rate (3.9% vs. 7.7%, P=0.4) and decreased late loss inside the stent (0.26 vs. 0.74, P <0.001) in the biolimus A9 stent group as compared with the bare metal stent group. No restenosis occurred at the proximal or distal edges of the stent in either group. Intravascular ultrasound (IVUS) analysis indicated significantly lower % neointimal volume in the biolimus A9 stent group as compared with the bare metal stent control group (2.6% vs. 23.5%, P<0.001). No deaths and a low rate of major adverse cardiac events indicated a good safety profile for this new drug eluting stent.
Terumo Corporation, Tokyo, Japan, is a premier global medical company with 2003 annual sales in excess of $2 billion and Terumo Europe N.V. is an affiliate of the company in Europe. Terumo Corporation develops, manufactures, and markets a wide range of medical products including cardiovascular systems, disposable medical devices, therapeutic catheters, I.V. solutions, blood bags, diabetes care systems, and medical electronic products in more than 160 countries.