Conor Medsystems Receives FDA Approval for Full Expansion of COSTAR II Drug Eluting Stent Trial
MENLO PARK, Calif., Dec. 1 -- Conor Medsystems, Inc. (Nasdaq: CONR) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to expand enrollment in its COSTAR II U.S. pivotal clinical trial to the full cohort of 1,700 patients at up to 85 sites. Conor received conditional investigational device exemption approval from the FDA to begin the trial with a limited number of sites in March 2005, and the first patient was enrolled in the study in May 2005.
Conor's COSTAR II U.S. pivotal clinical trial (CObalt chromium STent with Antiproliferative
for Restenosis) is a randomized, single-blind, non-inferiority study comparing
Conor's CoStar(TM) cobalt chromium paclitaxel-eluting 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
are
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 is 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. The principal investigators for the study are Dean J. Kereiakes, MD, FACC, Medical Director of The Heart Center of Greater Cincinnati and The Lindner Clinical Trials Center in Cincinnati, Ohio; Mitchell Krucoff, MD, FACC of Duke University Medical Center, Durham, North Carolina; and William Wijns, MD, PhD, of the Cardiovascular Center, Onze Lieve Vrouw Hospital, Aalst, Belgium. Conor expects that the data from this clinical trial will support its application for U.S. regulatory approval of Conor's CoStar stent.
In contrast to conventional surface-coated stents, Conor's stents have been specifically designed for vascular drug delivery. The company's drug-eluting stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. In addition, the CoStar stent uses bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent residual polymers at the target site.
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.
This press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation, the statements related to clinical trial enrollment and regulatory approval of our CoStar stent. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. 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 September 30, 2005 filed with the SEC on November 14, 2005, including, without limitation, 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 the long-term results the company obtains with its CoStar stent in the COSTAR II trial 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 problems associated with the control stent to be used in the COSTAR II trial, patients not enrolling in the COSTAR II trial at the rate we expect, 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 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. These 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 September 30, 2005.
SOURCE Conor Medsystems, Inc. |
