Conor Medsystems, Inc. announced that the first patient has been treated with the company's novel dual-drug coronary stent, SymBio, as a special use lead-in case to the initiation of the company's Genesis clinical trial. The Genesis trial will be a randomized, multi-centre study comparing the safety and efficacy of Conor's two new drug-eluting coronary stents to its CoStar cobalt chromium paclitaxel-eluting coronary stent system for the prevention of restenosis. The two new stents that will be evaluated in the Genesis study are the company's Corio pimecrolimus-eluting coronary stent system and the SymBio pimecrolimus/paclitaxel-eluting coronary stent system.

"The SymBio stent capitalizes on the advantages of Conor's reservoir-based stent design to deliver more than one drug. In addition, the use of bioresorbable polymers ensures that no permanent polymer residue or drug remains at the target site, which may confer a long-term advantage with respect to reduced rates of late stent thrombosis," Keith D. Dawkins, director of cardiac interventions at Southampton University Hospital, Southampton, United Kingdom, and one of the principal investigators for the genesis study said adding, "I am privileged to have treated the first patient with the SymBio stent and to be part of this innovative clinical trial comparing Conor's two new drug-eluting stents with the company's CoStar stent."

"Our goal is to bring innovative products to patients in the treatment of coronary artery disease," said Azin Parhizgar, Chief Operating Officer of Conor. "We are excited to begin a clinical study that evaluates the anti-inflammatory pimecrolimus and the anti-proliferative paclitaxel in a single stent with independent drug release kinetics," he added.

The primary endpoint for the Genesis study will be angiographic in-stent late lumen loss at six-month follow-up. Other endpoints will include major adverse cardiac events (MACE), target lesion revascularization (TLR), in-segment and in-stent binary restenosis and in-segment late loss as measured by angiography.

Pimecrolimus, which was in-licensed by Conor from Novartis Pharma AG in March 2006, is a cell-selective inhibitor of the production and release of pro-inflammatory cytokines. Inflammation is believed to be one of the key mechanisms causing restenosis, or the excess proliferation of vascular smooth muscle cells, as well as other vascular diseases such as unstable plaques and diabetic lesions. Paclitaxel is an anti-proliferative drug initially developed to treat certain types of cancer.

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, Conor's cobalt chromium drug-eluting stents use bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent polymer residues at the target site.