MENLO PARK, Calif., Oct. 21 /PRNewswire-FirstCall/ -- Conor Medsystems, Inc. , a developer of innovative, controlled vascular drug delivery technologies, today announced positive six-month clinical data from the second arm of its pivotal EuroSTAR study and twelve-month follow-up clinical data from its pilot COSTAR I study, each Positive results from both studies were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) conference, a leading scientific symposium in interventional cardiology, in Washington, DC.
“We are pleased with the positive results achieved in the evaluation of our CoStar stent’s safety and efficacy,” said Frank Litvack, MD, Chairman and CEO of Conor. “We have now completed our extensive series of dose and kinetic ranging clinical studies for our CoStar stent, and believe the 10mcg, long release formulation of paclitaxel, coupled with our bioresorbable polymer, provides clear benefits to both patients and physicians.”
EuroSTAR Data
EuroSTAR (EUROpean cobalt chromium STent with Antiproliferative for Restenosis) is a prospective, multi-center, sequentially enrolled, non-randomized, two-arm dose-ranging pivotal trial evaluating the safety and performance of Conor’s CoStar stent for the treatment of restenosis. Arm II of Conor’s EuroSTAR study treated a total of 145 lesions in 137 patients using the CoStar stent formulated to release a therapeutic dose of 30mcg of paclitaxel per 17mm stent over approximately 30 days (based on in vitro measurements). At six-month follow-up, the in-stent binary restenosis rate was 6.9 percent, the in-stent late loss was 0.39 millimeters, the target lesion revascularization (TLR) rate was 3.6 percent, and the rate of cumulative major adverse cardiac events (MACE) was 9.2 percent.
In March 2005 Conor reported positive six-month follow-up data on Arm I of the EuroSTAR trial with 145 patients using the CoStar stent formulated to release a therapeutic dose of 10mcg of paclitaxel over approximately 30 days (in vitro). At six-month follow-up in Arm I, the in-stent binary restenosis rate was 3.4 percent, the in-stent late loss was 0.26 millimeters, the TLR rate was 1.7 percent, and the MACE rate was 4.8 percent. The more favorable results received in Arm I, as compared to Arm II announced today, reinforce Conor’s decision to commercialize the CoStar stent with a 10mcg dose of paclitaxel.
COSTAR I Data
COSTAR I (CObalt chromium STent with Antiproliferative for Restenosis), Conor’s multi-center, three-arm, dose-ranging registry is a pilot study evaluating the safety and performance of the CoStar stent with formulations of 3mcg, 10mcg and 30mcg of paclitaxel. A total of 122 lesions were treated in 87 individuals from a highly complex patient population. On average, among the three patient groups participating in COSTAR I, nearly 50 percent had a prior myocardial infarction (heart attack) and approximately 25 percent were diabetic. Other complex characteristics of the patient group included small diameter coronary vessels and long lesions.
The formulation with 10mcg of paclitaxel was the most efficacious of the doses studied in the COSTAR I trial, and it was clinically unchanged from four to twelve months. At both four-month and twelve-month follow-up, the TLR rate was 1.8 percent and the rate of cumulative MACE was 7.5 percent for the 40 patients who received this formulation. There were no cases of stent thrombosis among the 87 patients between the cessation of anti-platelet therapy at six months and twelve-month follow-up.
About the CoStar stent
Data from Conor’s EuroSTAR trial was used to support the company’s CE Mark application filed earlier this year. Pending regulatory approval, the CoStar stent will be marketed in Europe, Latin America and parts of Asia by one of the company’s distribution partners, Biotronik AG. In March, a limited market release of the CoStar stent began in India through Conor’s South Asia distribution partner, Interventional Technologies, Pvt, Ltd. Conor is currently conducting a U.S. pivotal trial, the COSTAR II study, to support its application for U.S. regulatory approval of the CoStar stent.
In contrast to conventional surface-coated stents, Conor’s stents have been specifically designed for vascular drug delivery. The company’s CoStar cobalt chromium paclitaxel-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 residual polymers at the target site.
The CoStar stent is not available for sale in the United States where it is an investigational device limited by law to investigational use.
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.
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 clinical development, potential regulatory approval of the CoStar stent and the company’s commercialization plans. 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 June 30, 2005, filed with the SEC on August 12, 2005, 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; (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 the company obtains with its CoStar stent, (b) the risk that issues in the company’s manufacturing processes could delay or impede the company’s clinical development plans, (c) 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 (d) 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 the CoStar stent in the European Community; (iv) the risk that the company’s CoStar stent may not achieve market acceptance, even if the company obtains necessary regulatory approvals; (v) the risk that the loss of the company’s single source suppliers could prevent or delay commercialization of the CoStar stent; (vi) the risk that the company or its suppliers may not achieve or maintain required regulatory approvals for manufacturing operations, which could delay or impede the company’s commercialization efforts; and (vi) the risk that the company may not be able to maintain arrangements with third parties to market and sell the CoStar stent. 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 company’s periodic reports filed with the SEC, including the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2005.
Conor Medsystems, Inc.
CONTACT: investors, Michael Boennighausen, Chief Financial Officer ofConor Medsystems, Inc., +1-650-614-4100; or media, Karen L. Bergman of BCCPartners, +1-650-575-1509, or Nan Foster, +1-415-307-6955, both for ConorMedsystems, Inc.
Web site: http://www.conormed.com//
