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Conor Medsystems Initiates COSTAR II Pivotal Drug-Eluting Stent Clinical Trial in U.S.
First Patient Enrolled in Study of Conor's CoStar® Drug-Eluting Stent Among Real-World Population
MENLO PARK, Calif., May 24 /PRNewswire-FirstCall/ - Conor Medsystems, Inc. (Nasdaq: CONR), a developer of innovative controlled vascular drug delivery technologies, today announced that the first patient has been enrolled in the company's COSTAR II U.S. pivotal clinical trial. The COSTAR II trial (CObalt chromium STent with Antiproliferative for Restenosis) is designed to randomize approximately 1,700 patients at up to 75 U.S. sites and 15 international sites. Conor expects the data from this trial to support its application for U.S. regulatory approval of Conor's CoStar® cobalt chromium paclitaxel-eluting stent. The first patient procedure was performed by Dean J. Kereiakes, MD, FACC, Medical Director of The Heart Center of Greater Cincinnati and The Lindner Clinical Trials Center in Cincinnati, Ohio, and one of the principal investigators for the trial.
"I am excited to be part of the initiation of this innovative clinical trial evaluating Conor's unique cobalt chromium drug delivery stent compared to a first-generation drug eluting stent," said Dr. Kereiakes. "This study will be of particular interest to the interventional cardiologist community because the trial will include patients with multi-vessel disease which more closely represent the real-world population. There is limited data available on the use of drug-eluting stents in multi-vessel disease, so data from this trial will be especially meaningful to clinicians who are looking for the best technologies to treat patients with complex coronary artery disease. In addition, the design of Conor's CoStar stent appears to have several potential advantages as compared to conventional drug eluting stents, including a low profile for ease of navigation and placement in smaller vessels, the ability to control the release kinetics of the drug, and the use of a bioresorbable polymer that leaves no residual polymer or drug on the stent."
The COSTAR II trial is a randomized, single-blind, non-inferiority study comparing Conor's CoStar stent with Boston Scientific's TAXUS® Express2™ drug-eluting stent in the treatment of de novo lesions in patients with single or multi-vessel coronary artery disease. The CoStar stent is loaded with a dose of 10 mcg of paclitaxel per 17 mm stent using a bioresorbable polymer, a formulation determined to be efficacious during the company's European clinical studies. Patients will be asymmetrically randomized between CoStar 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. Enrollment is anticipated to be completed in approximately six to nine months.
The primary endpoint for the study will be major adverse cardiac events (MACE) at eight months, defined as a composite of target vessel revascularization (TVR), myocardial infarction and cardiac-related death. Other endpoints include target lesion revascularization (TLR), binary restenosis and in-segment and in-stent late loss as measured by angiography. The trial will include a continued access registry for direct stenting. The principal investigators for the study in the U.S. are Dr. Kereiakes and Mitchell Krucoff, MD, FACC of Duke University Medical Center, Durham, North Carolina.
"We are very pleased to have begun this important pivotal trial with leading clinical investigators from around the world," said Azin Parhizgar, PhD, Chief Operating Officer of Conor. "Conor's stents are uniquely designed for optimized drug delivery, and we believe they represent the next-generation of drug-eluting stent technologies, allowing for greater control over the direction, rate and duration of drug release. To date, we have obtained positive safety and efficacy data on our CoStar stent, including the twelve-month follow-up data from our pivotal EuroSTAR study being presented at the EuroPCR meeting in Paris."
In contrast to conventional surface-coated stents, Conor's stents have been specifically designed for vascular drug delivery. The company's stents incorporate 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 cobalt chromium paclitaxel-eluting stent uses bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent polymer residues at the target site.
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 and potential regulatory approval of the CoStar stent. 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 the heading "Risk Factors" in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, filed with the SEC on May 16, 2005, including (i) the risk that if any patent infringement claims or other intellectual property claims against the company are successful, the company may, among other things (a) 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, (b) 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 (c) be required to obtain licenses to the infringed intellectual property, which may not be available to the company on acceptable terms, or at all; (ii) 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; and (iii) 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 the recall or removal from the market of the control stent to be used in the COSTAR II trial, or as a result of patients experiencing adverse side effects or events related to the CoStar stent, which could result in substantial delays and 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 company may not satisfy the requirements of the FDA's conditional approval of the company's investigational device exemption application to begin enrollment in the COSTAR II trial on a timely basis, or at all, which could result in substantial delays or the company being required cease enrollment in the trial, and (f) 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. 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2005.
SOURCE Conor Medsystems, Inc.
05/24/2005
CONTACT: investors, Michael Boennighausen, Chief Financial Officer of Conor Medsystems, Inc., +1-650-614-4100, or press, Karen L. Bergman of BCC Partners, +1-650-575-1509, or Nan Foster, +1-415-307-6955, both for Conor Medsystems, Inc.
Web site: http://www.conormed.com
