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Published on 4/20/2006 in the Prospect News Biotech Daily.

Enrollment of 1,700 patients completed in Conor Medsystems' drug-eluting stent trial

By Lisa Kerner

Erie, Pa., April 20 - Conor Medsystems, Inc. said it has completed enrollment of 1,700 patients in its U.S. pivotal clinical trial, CoStar II (CObalt chromium STent with Antiproliferative for Restenosis).

The CoStar II trial is a randomized, single-blind, non-inferiority trial being conducted in 61 U.S. and 11 international sites.

Conor said the trial will compare the safety and efficacy of its 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.

Patients will undergo clinical follow-up at 30 days and eight months. A 350-patient subset will undergo follow-up angiography at nine months.

The primary endpoint for the CoStar II study is major adverse cardiac events at eight months.

"I am delighted that we have completed enrollment in the CoStar II trial, moving us another step closer to the U.S. market," chief operating officer Azin Parhizgar said in a company news release.

"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."

Favorable results of this clinical trial would lead to submission of a marketing approval application with the Food and Drug Administration for its CoStar stent in early 2007, the company said.

Conor, based in Menlo Park, Calif., develops vascular drug delivery technologies.


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