Healthcare Industry News: Novartis Pharma AG
News Release - May 18, 2006
Conor Medsystems Announces First Patient Treated with Dual-Drug Coronary StentGENESIS Study to Compare New Corio(TM) and SymBio(TM) Stents to CoStar(TM) Stent
MENLO PARK, Calif., May 18 (HSMN NewsFeed) -- Conor Medsystems, Inc. (Nasdaq: CONR ) today announced that the first patient has been treated with the company's novel dual-drug coronary stent, SymBio(TM), 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-center study comparing the safety and efficacy of Conor's two new drug-eluting coronary stents to its CoStar(TM) 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(TM) pimecrolimus-eluting coronary stent system and the SymBio(TM) pimecrolimus/paclitaxel-eluting coronary stent system. Enrollment in the clinical trial is anticipated to commence this summer and be completed in late 2006 or early 2007.
"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," said Keith D. Dawkins, M.D., FRCP, FACC, Director of Cardiac Interventions at Southampton University Hospital, Southampton, United Kingdom, and one of the principal investigators for the GENESIS study. "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, Ph.D., 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."
The GENESIS trial will be a prospective, randomized, multi-center, open label, three-arm, non-inferiority trial designed to enroll up to 375 patients to compare the safety and efficacy of the Corio and SymBio stents to the CoStar stent in the treatment of de novo coronary lesions. Patients will be asymmetrically randomized among the three stents and will undergo clinical follow-up at 30 days and coronary angiography at six months, with clinical follow-up at 12 months and annually thereafter to five years. In addition, a 30-patient subset in each treatment arm will undergo intravascular ultrasound (IVUS) evaluation at six months.
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. The study will be conducted at up to 25 centers in Europe and Israel. In addition to Dr. Dawkins, Stefan Verheye, M.D., Ph.D. of the Middleheim Hospital, Antwerp, Belgium, is also a principal investigator for the trial.
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.
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 of the Corio and SymBio stents. 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 "Item 1A. Risk Factors" in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2006, filed with the SEC on May 10, 2006, including (i) risks related to the uncertain, lengthy and expensive clinical development process, including, among other things, (a) the risk that the company's Corio and SymBio stents, which are in early stage clinical development, may not demonstrate safety or efficacy in humans, (b) the risk that the GENESIS trial may not begin on time, or at all, including as a result of patients not enrolling in the trial at the rate the company expects, (c) the risk that the GENESIS trial may not be completed on schedule, or at all, including as a result of patients experiencing adverse side effects or events related to the Corio or SymBio stents which could result in termination of the trial, substantial delays or a redesign of the trial, (d) the risk that the third parties on whom the company relies to conduct its clinical trials may not perform as contractually required or as expected, (e) the risk that issues in the company's manufacturing processes could delay or impede the company's clinical development plans, and (f) the risk that clinical trial sites may decide not to participate or to cease participation in the GENESIS trial; and (ii) risks related to patent infringement, including, among other things, (a) the risk that if any patent infringement claims or other intellectual property claims against the company are successful, the company may, among other things (1) be enjoined from, or required to cease, the development, manufacture, use and sale of products that infringe the patent rights of others, (2) 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 (3) be required to obtain licenses to the infringed intellectual property, which may not be available to the company on acceptable terms, or at all, and (b) 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. 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 year ended March 31, 2006, filed with the SEC on May 10, 2006.
Source: Conor Medsystems
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