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Conor Medsystems Presents Positive 12-Month Results from PISCES First- Generation Paclitaxel Drug-Eluting Stent Trial at American College of Cardiology Scientific Session
Results Reinforce Safety, Optimal Dose and Kinetic Release Characteristics of Innovative Stainless Steel Paclitaxel Drug Delivery Stent Technology
MENLO PARK, Calif., March 8, 2005 /PRNewswire-FirstCall via COMTEX/ - Conor Medsystems, Inc. (Nasdaq: CONR) today presented twelve-month follow-up data from its PISCES (Paclitaxel In-Stent Controlled Elution Study) clinical trial at the American College of Cardiology (ACC) scientific session in Orlando, Florida. The data, presented by Patrick Serruys, M.D., Ph.D., Chief, Interventional Cardiology, Thoraxcenter-Erasmus University in Rotterdam and the study's Principal Investigator, support the long-term safety and efficacy of Conor's novel cardiovascular stent technology. PISCES was designed to study Conor's first-generation stainless steel paclitaxel-eluting stent in the treatment of native coronary artery lesions. In a related announcement earlier this week, Conor also presented positive clinical safety, efficacy and angiographic findings on the company's CoStar® cobalt chromium drug-eluting stent.
"We are very pleased with PISCES' twelve-month data, which confirms the safety of our proprietary stent technology," said Frank Litvack, M.D., Chairman and CEO of Conor. "Building off the insights we gained from this first-generation technology, we have designed our cobalt chromium CoStar paclitaxel-eluting stent, which has thinner struts and uses significantly less polymer, to provide controlled delivery of therapeutic levels of drug."
PISCES, a multi-center study involving 191 patients from ten sites across seven countries, was designed to compare the safety and performance of paclitaxel delivered at different rates, directions, and doses using Conor's stainless steel stent. Each patient participating in the PISCES trial received one of six different formulations of paclitaxel to evaluate unique doses, drug release rates (fast, medium and slow) and directionality (drug release to only the arterial wall versus release to both the wall and the lumen).
At twelve-month follow-up, all six formulations were determined to be safe and efficacious. There were no reported cases of delayed stent thrombosis between six months, when patients ceased antiplatelet therapy, and twelve- month follow-up. In comparison to the other four formulations, the two groups with slow-release formulations (approximately 30 days based on in vitro measurements) had particularly good outcomes.
The group of patients receiving a 10mcg (per 17mm stent) slow-release formulation had an in-stent binary restenosis rate of 0 percent and a target lesion revascularization (TLR) rate of 0 percent at twelve-month follow-up. The rate of major adverse cardiac events (MACE) was 5.1 percent, not statistically different from the MACE rate at four months. From four-month to twelve-month follow-up, in-stent late loss increased to 0.52mm from 0.40mm, and in-segment late loss increased to 0.30mm from 0.21mm.
In the group of patients receiving a slow-release formulation of 30mcg, the in-stent binary restenosis rate was 5.6 percent, the TLR rate was 6.9 percent, and the MACE rate was 6.9 percent, not statistically different from the MACE rate at four months. From four-month to twelve-month follow-up, in- stent late loss increased to 0.36 mm from 0.32mm, and in-segment late loss increased to 0.24mm from 0.21mm.
As reported earlier, six-month follow-up data from Conor's pivotal EuroSTAR study examining the company's CoStar stent showed an in-stent binary restenosis rate of 3.4 percent, an in-stent late loss of 0.26 millimeters, and an in-segment late loss of 0.07 millimeters. The TLR rate was 1.7 percent and the MACE rate was 4.8 percent. Conor's CoStar stent has a 30 percent reduction in strut thickness, a lower crossing profile and a reduced polymer volume as compared to the earlier generation stainless steel stent platform used in the PISCES trial. The EuroSTAR data were presented on March 5 at the DES Revolution IV, a Cardiovascular Research Foundation-sponsored symposium immediately preceding the ACC meeting. Conor plans to seek regulatory approval for its CoStar stent worldwide.
In contrast to conventional surface-coated stents, Conor's coronary stent has been specifically designed for vascular drug delivery. Conor's stent design differs from conventional surface-coated stents as it incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. This stent design enables a wider range of drug therapies -- including combinations of multiple compounds -- and provides greater control over the direction and rate of drug release, which Conor believes allows for more targeted treatment within the artery and more efficient use of the therapeutic agent.
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 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 product development and regulatory approval. 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 third parties on whom the Company relies to conduct its clinical trials may not perform as contractually required or expected, (c) the risk that the Company's clinical trials may not be completed on schedule, or at all, and (d) the risk that the Company may never obtain FDA and equivalent foreign market approvals. 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.
SOURCE Conor Medsystems, Inc.
Investors: Michael Boennighausen, Chief Financial Officer of Conor Medsystems, Inc., +1-650-614-4100; or Media: Karen Bergman of BCC Partners, +1-650-575-1509, or Nan Foster, +1-415-307-6955, both for Conor Medsystems, Inc.
