Conor Medsystems Completes Enrollment of COSTAR II Pivotal Randomized Drug-Eluting Stent Trial
Multi-Center Study Evaluating Safety and Efficacy of
Conor's CoStar™ Cobalt
Chromium Paclitaxel-Eluting Stent
MENLO PARK, Calif., April 20 -- Conor Medsystems, Inc. (Nasdaq: CONR -
News), a developer of innovative controlled vascular drug delivery technologies,
today announced that the company has completed enrollment of 1,700 patients in
its U.S. pivotal randomized clinical trial, COSTAR II (CObalt chromium STent
with Antiproliferative for Restenosis). If the results of this clinical trial
are favorable, the company anticipates submitting an application for marketing
approval with the U.S. Food and Drug Administration for its CoStar™
stent in early 2007 and potentially receiving regulatory approval in late 2007
or early 2008.
The COSTAR II trial is a randomized, single-blind, non-inferiority trial that
compares the safety and efficacy of Conor's CoStar cobalt chromium paclitaxel-eluting
stent with Boston Scientific's TAXUS® Express(2)™ paclitaxel-eluting
coronary stent system in the treatment of de novo lesions in patients with single
or multi-vessel coronary artery disease. This trial is being conducted in 61
U.S. sites and 11 international sites. Patients were asymmetrically randomized
between the CoStar stent and the control stent with clinical follow-up at 30
days and eight months. In addition, a 350-patient subset will undergo follow-up
angiography at nine months. Conor's CoStar stent is loaded with 10 mcg of paclitaxel
per 17 mm stent and incorporates a bioresorbable polymer.
"I am very pleased that such a large study of cardiovascular disease in a 'real-world' population completed enrollment so quickly, which I believe reflects the quality of the clinical sites as well as the widespread interest in Conor's CoStar stent," said Mitchell Krucoff, M.D., FACC of Duke University Medical Center, Durham, North Carolina and a principal investigator for the COSTAR II study. "I believe the design of Conor's CoStar stent may offer several potential advantages as compared to conventional drug-eluting stents, including no surface coating, a low profile for ease of delivery and the use of a polymer that is absorbed by the body, leaving a bare metal stent. I look forward to analyzing the comparative data."
"I am delighted that we have completed enrollment in the COSTAR II trial, moving us another step closer to the U.S. market," said Azin Parhizgar, Ph.D., Chief Operating Officer of Conor. "We believe that the proprietary design of our CoStar stent provides for optimized drug delivery and may provide advantages in treating coronary artery disease. We expect that results from this trial will be available in the first half of 2007."
The primary endpoint for the COSTAR II study is major adverse cardiac events at eight months, defined as a composite of target vessel revascularization, myocardial infarction and cardiac-related death. Other endpoints include target lesion revascularization, binary restenosis and in-segment and in-stent late loss as measured by angiography. In addition to Dr. Krucoff, Dean J. Kereiakes, M.D., FACC, Medical Director of The Heart Center of Greater Cincinnati and The Lindner Clinical Trials Center in Cincinnati, Ohio and William Wijns, M.D., Ph.D., of the Cardiovascular Center, Onze Lieve Vrouw Hospital, Aalst, Belgium are principal investigators for the COSTAR II study.
In contrast to conventional surface-coated drug-eluting stents, Conor's CoStar cobalt chromium paclitaxel-eluting stent has been specifically designed for vascular drug delivery. The CoStar stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. Through this reservoir design, Conor believes that it can greatly enhance control over the rate and direction of drug release and enable a wider range of drug therapies. In addition, the CoStar stent uses a bioresorbable polymer that is absorbed by the body after the drug is released, leaving no permanent polymer residues at the target site. In February 2006, Conor's CoStar stent received CE Mark approval for the treatment of coronary artery disease, and it is currently being marketed in certain countries in the European Union, Latin America and Asia through the company's distributors.
The CoStar stent is not available for sale in the United States where it is an investigational device limited by law to investigational use.
About Conor Medsystems
Conor Medsystems, Inc. develops innovative controlled vascular drug delivery technologies, and has initially focused on the development of drug-eluting stents to treat coronary artery disease. For further information on Conor Medsystems and controlled vascular delivery, visit www.conormed.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to clinical development, submission of an application for and potential receipt of regulatory approval of the CoStar stent and the expected timing of the results from the COSTAR II trial. All forward-looking statements and other information included in this press release are based on information available to Conor Medsystems as of the date hereof, and the company assumes no obligation to update any such forward-looking statements or information. The company's actual results could differ materially from those described in the company's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under "Item 1A. Risk Factors" in the company's Annual Report on Form 10-K for the year ended December 31, 2005, filed with the SEC on March 16, 2006, including (i) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including, among other things, (a) the risk that clinical results reported to date may not be indicative of future clinical results and that longer-term results the company obtains with its CoStar stent may not show similar effectiveness, (b) the risk that the COSTAR II trial may not be completed on schedule, or at all, including as a result of patients experiencing adverse side effects or events related to the CoStar stent, which could result in termination of the trial, substantial delays or a redesign of the trial, (c) the risk that issues in the company's manufacturing processes could delay or impede the company's clinical development plans, (d) the risk that the third parties on whom the company relies to conduct its clinical trials may not perform as contractually required or expected, and (e) risks related to regulation by the FDA and the company's limited experience in regulatory affairs, including the risk that that the company may never obtain FDA approval; and (ii) risks related to patent infringement, including, among other things, (a) the risk that if any patent infringement claims or other intellectual property claims against the company are successful, the company may, among other things (1) be enjoined from, or required to cease, the development, manufacture, use and sale of products that infringe the patent rights of others, including the company's CoStar stent, (2) be required to expend significant resources to redesign its technology so that it does not infringe others' patent rights, which may not be possible, and/or (3) be required to obtain licenses to the infringed intellectual property, which may not be available to the company on acceptable terms, or at all, and (b) the risk that intellectual property litigation against the company could significantly disrupt the company's development and commercialization efforts, divert management's attention and quickly consume the company's financial resources. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the company's periodic reports filed with the SEC, including the company's Annual Report on Form 10-K for the year ended December 31, 2005.
Source: Conor Medsystems, Inc. |
