Patient Enrollment Complete for Pivotal Trial of the NEVO Sirolimus-eluting Coronary Stent with Unique Reservoir Technology
Patient Enrollment Complete for Pivotal Trial of the NEVO Sirolimus-eluting Coronary Stent with Unique Reservoir Technology
October 27, 2008--WARREN, N.J.--(BUSINESS WIRE)--Cordis Corporation and Conor Medsystems, LLC announced today that patient enrollment has been completed for a randomized clinical trial comparing the NEVOTM Sirolimus-eluting Coronary Stent, a new cobalt chromium reservoir-based stent design, to the Taxus® Liberte® Paclitaxel-eluting Coronary Stent.
Data from this trial-known as RES-ELUTION I-may be used to support a regulatory filing for a CE Mark in countries outside the United States. Cordis expects the primary data will be available next spring.
NEVOTM utilizes a unique RES Technology that incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This revolutionary design allows drug delivery from an implant the surface of which is 75 percent polymer-free bare metal upon insertion and becomes fully bare metal following drug delivery and polymer bioresorption in approximately three months. The technology also greatly enhances control of the rate and direction of drug delivery, enabling a wider range of drug therapies to be delivered, and potentially increases the range of clinical applications of drug-eluting stents and other drug-device combinations.
NEVOTM contains the same drug, sirolimus, as in the CYPHER® Sirolimus-eluting Coronary Stent. The data supporting the safety and efficacy of sirolimus in coronary applications is now available out to six years, and is completely unmatched by any other anti-restenotic stent coating.
"The potential of sirolimus delivery from a fully-bioresorbable reservoir is exciting and this study is an important step in evaluating its use in the interventional treatment of patients with coronary artery disease," said John Ormiston, M.D., North Shore Hospital, Auckland, New Zealand and Principal Investigator for this study. The other Principal Investigators are Christian Spaulding, M.D., Cochin Hospital, Paris, France and Alex Abizaid, MD, PhD, Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil.
Drs. Spaulding and Abizaid are members of the Cordis's Scientific Advisory Board and Dr. Spaulding has spoken on Cordis's behalf at medical symposia and Dr. Ormiston has spoken on behalf of Conor.
The RES-ELUTION I study is a 388-patient, randomized, multi-center comparison of NEVOTM to the Taxus® Liberte® Stent in de Novo native coronary artery lesions. The primary endpoint of the study is angiographic in-stent late lumen loss at six months. Secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events (MACE), stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. Up to 100 patients will also be evaluated via intravascular ultrasound (IVUS) at six months.
RES-ELUTION I will also incorporate important health-economics metrics for the first time in any large clinical trial of a drug-eluting stent. This could lead to a new model for trials that not only provide important safety and efficacy data for submission to regulatory bodies but also give physicians crucial information about the value to the health-care system associated with this product.
The study involves 40 sites worldwide including Australia, Belgium, Brazil, Denmark, France, Germany, New Zealand, The Netherlands and the United Kingdom. Patients will receive clinical follow-up at 30 days, six months and annually through five years.
RES-ELUTION I is the first of three studies that may be used to support regulatory filings globally for NEVOTM. RES-ELUTION IINR is a non-randomized, single-arm registry of approximately 1,000 patients that will provide clinical safety and efficacy data about expanded patient and lesion experiences with long-term follow up. RES IINR is being conducted outside the United States; the first patient was enrolled in this trial in July.
In the U.S., a subsequent pivotal trial supporting a regulatory filing with the Food and Drug Administration called RES-ELUTION III will be conducted as well. That protocol is currently in development.
"We believe NEVOTM is an important new step in stent technology, a continuation of the Cordis tradition of innovation that began with our introductions of the first bare metal stent and the first drug-eluting stent," said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation.
About Conor Medsystems, LLC
Conor Medsystems, LLC, a wholly owned subsidiary of Johnson & Johnson, develops innovative controlled vascular drug delivery technologies, and has primarily focused on the development of drug-eluting stents to treat coronary artery disease. More information about RES Technology is available at www.res-technology.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
--Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.
--The third party trademarks used herein are trademarks of their respective owners.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
