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Conor Medsystems Receives Conditional IDE Approval From the FDA to Begin COSTAR II Pivotal Clinical Trial
CE Mark Application Filed in Europe MENLO PARK, Calif., March 23 -- Conor Medsystems, Inc. (Nasdaq: CONR) today announced that the company has received conditional approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin its COSTAR II pivotal clinical trial. The company expects the data from this trial to support U.S. regulatory approval of Conor's CoStar™ cobalt chromium paclitaxel eluting stent for the treatment of restenosis. The COSTAR II pivotal trial (CObalt chromium STent with Antiproliferative for Restentosis) is designed to enroll approximately 1,700 patients at up to seventy U.S. sites and fifteen international sites. The FDA's conditional approval of the IDE requires Conor to provide additional information to the FDA. The study is expected to begin by mid-year, and enrollment is estimated to take six to nine months to complete. "We are very pleased to achieve this significant milestone, and we look forward to commencing our pivotal U.S. study," said Azin Parhizgar, PhD, Chief Operating Officer of Conor. "To date, we have obtained positive safety and efficacy data on our CoStar stent -- most recently from the six-month follow-up data from our EuroSTAR trial. We believe these results are due to our stent's unique drug reservoir design, which allows for greater control over the direction, rate and duration of drug release. In the U.S. trial we will use the low dose of 10 mcg of paclitaxel per 17 mm stent with a bioresorbable polymer. This system is designed to completely release the drug without any permanent residual polymers remaining at the target site." The COSTAR II trial will be 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. Patients will be asymmetrically randomized between CoStar and the control stent with clinical follow-up at thirty days and eight months. In addition, a 350 patient subset will undergo follow-up angiography at 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 registry for direct stenting. Principal investigators involved in the study include Dean Kereiakes, MD, FACC of the Ohio Heart Health Center in Cincinnati, Ohio, Mitchell Krucoff, MD, FACC of Duke University Medical Center, Durham, North Carolina and Patrick Serruys, MD, PhD of the Thoraxcenter-Erasmus University in Rotterdam, The Netherlands. Earlier this month Conor reported positive six-month follow-up data from the first arm of the company's EuroSTAR study evaluating the CoStar stent. A total of 176 lesions were treated in 145 patients using the CoStar stent formulated to deliver a dose of 10 mcg of paclitaxel (per 17 millimeter stent) over approximately 30 days (based on in vitro measurements). The in-stent binary restenosis rate was 3.4 percent and the in-stent late loss was 0.26 millimeters. The in-segment binary restenosis rate was 4.7 percent and the in-segment late loss was 0.07 millimeters. The TLR rate was 1.7 percent and the MACE rate was 4.8 percent. CE Mark Application Data from the EuroSTAR trial was used to support the company's CE Mark application filed earlier this quarter for regulatory approval of its CoStar stent in the European Community. The company anticipates receiving regulatory approval for its CoStar stent in Europe in the second half of 2005. A limited market release of the CoStar stent began this month in India with the company's South Asian distribution partner, Interventional Technologies, Pvt, Ltd. 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. CoStar is not available for sale in the United States. CoStar is an investigational device limited by federal law to investigational use. 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 the planned 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 prospectus filed with the SEC on December 14, 2004 pursuant to Rule 424(b), 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 commence or 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, which could result in substantial delays and a redesign of the trial, or as a result of patients experiencing adverse side effects or events related to our CoStar stent, (c) the risk that the company may not satisfy the requirements of the FDA's conditional IDE approval on a timely basis or at all, (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 foreign regulatory authorities and the company's limited experience in regulatory affairs, including the risk that that the company may never obtain FDA and equivalent foreign market approvals, including approval to market our CoStar stent in the European Community. 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 prospectus and the company's future periodic reports to be filed with the SEC. CONTACT: investors, Michael Boennighausen, Chief Financial Officer of Conor Medsystems, +1-650-614-4100; or Karen L. Bergman, +1-650-575-1509, or Nan Foster, +1-415-307-6955, both of BCC Partners, for Conor Medsystems Web site: http://www.conormed.com SOURCE: Conor Medsystems, Inc. |
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