Healthcare Industry News: stent thrombosis
News Release - May 11, 2006
Conor Medsystems Initiates RAPID Clinical Study for First Pimecrolimus Drug-Eluting StentStudy to Evaluate Reduced Duration of Anti-Platelet Therapy Following Stent Implantation
MENLO PARK, Calif., May 11 (HSMN NewsFeed) -- Conor Medsystems, Inc. (Nasdaq: CONR ) today announced that the company has initiated the RAPID (Reduced Anti-platelet therapy with Pimecrolimus Drug-eluting stent) clinical trial to evaluate the safety and efficacy of the company's pimecrolimus-eluting cobalt chromium coronary stent system, known as Corio(TM). The study will also evaluate a reduced duration of post-procedure anti-platelet therapy.
The Corio stent combines Conor's novel reservoir-based stent platform with pimecrolimus for the prevention of restenosis. 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. Because pimecrolimus is not an anti-mitotic compound, it is believed not to inhibit re-endothelialization, or the growth of the endothelial cells that line the interior surface and maintain the healthy functioning of blood vessels. Following implantation of the Corio stent, the drug is released and the polymer is absorbed after a number of months.
"Conor is committed to developing innovative drug-eluting stents that improve patient outcomes," said Azin Parhizgar, Ph.D., Chief Operating Officer of Conor. "The ability to potentially eliminate months of post-procedure anti-platelet therapy would represent a significant benefit to patients in terms of safety, convenience and cost."
"Conor's novel reservoir-based stent platform allows for the complete delivery of the drug and the elimination of any polymer residues; all that ultimately remains is a bare metal stent," said Alexandre Abizaid, M.D., of the Institute Dante Pazzanese, Brazil, and principal investigator for the study. "Conor's use of a polymer that is absorbed by the body may reduce the incidence of late stent thrombosis, a very serious complication that may be associated with conventional surface-coated drug-eluting stents utilizing non-bioresorbable polymers."
The RAPID trial is a prospective, open label, multi-center registry designed to enroll up to 150 patients who, after implantation of the Corio stent, will receive two months of aspirin and clopidogrel dual anti-platelet therapy. Thereafter, the patients will be treated with aspirin only. All subjects will undergo clinical follow-up at 30 days and coronary angiography at six months, with clinical follow-up at 12 and 24 months. In addition, a subset of 50 patients will also undergo intravascular ultrasound (IVUS) evaluation at six months.
The primary endpoint for the RAPID study will be angiographic in-stent late loss at six-month follow-up. Other endpoints 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 RAPID study is being conducted at up to 15 centers in Brazil and Europe. Data from the RAPID study will be compared with historical controls from Arm 1 of Conor's EuroSTAR study which evaluated the company's CoStar(TM) cobalt chromium paclitaxel-eluting coronary stent system. Enrollment is anticipated to be completed in the second half of this year, and the company expects the initial results of the trial to be available in 2007.
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.
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 stent. 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 stent, which is in early stage clinical development, may not demonstrate safety or efficacy in humans, (b) the risk that the RAPID 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 stent which could result in termination of the trial, substantial delays or a redesign of the trial, (c) 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, (d) the risk that issues in the company's manufacturing processes could delay or impede the company's clinical development plans, and (e) the risk that clinical trial sites may decide to cease participation in the RAPID 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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