Healthcare Industry News: estradiol
News Release - May 16, 2006
X-Cell Medical Completes Enrollment for Clinical Trial of ETHOS II Estradiol Eluting StentPRINCETON, N.J.--(HSMN NewsFeed)--May 16, 2006--X-Cell Medical, Inc. announced today that the Company has completed enrollment in its ETHOS II multinational clinical trial to study the safety and effectiveness of the ETHOS Coronary Stent System.
ETHOS II drug eluting stents (DES) are coated with a second generation formulation of 17(beta)-estradiol, an approved drug used in hormone replacement therapy and other indications, and are specifically designed to enhance safety through substantially reduced polymer load and estradiol dose. estradiol-specific elution kinetics was also designed based on the Company's porcine tissue uptake studies. The ETHOS II trial is complimentary to the Company's ongoing ETHOS I trial, with full 6-month follow-up data to be reported in the second half of 2006.
"The medical community is increasingly concerned with the incidence of thrombosis and other safety issues, which may stem from over-dosing of drugs as well as sub-optimal polymer formulations," said X-Cell Medical President and CEO, Dr. Oded Ben-Joseph. "In this regard, we believe that the ETHOS system constitutes a highly differentiated product not only with respect to the offering of a new drug class but also with respect to its potentially superior safety characteristics," added Ben-Joseph.
"We are pleased with the aggressive timelines that X-Cell has been able to achieve in the ETHOS I and ETHOS II trials," said Steve Peltier, X-Cell's Executive Director of Regulatory Affairs. "Our clinical investigators continue to report positive outcomes at the time of implantation across a broad range of patients with coronary artery disease. To date, there have been no reports of major adverse cardiac events for ETHOS II. This early data continues to support the growing evidence of the safety of 17(beta)-estradiol as reflected by no incidence of thrombosis in either ETHOS I (6-months) or ETHOS II trials thus far."
About the ETHOS II study
ETHOS II is a three-center, open label study during which patients will receive a novel formulation of estradiol with reduced polymer load. The study will include 35 patients with diagnosed stable and unstable angina or documented silent ischemia, with angiographic and intravascular ultrasound (IVUS) follow-up at 6 months to measure the percent in-stent volume obstruction. The data from ETHOS II will be compared with ETHOS I, which also includes a leading bare-metal stent, for the elimination of restenosis in patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to discrete de novo and/or restenotic coronary artery lesions. Ultimately, the results of this comparison will enable X-Cell to proceed toward a US pivotal trial with a fully optimized product.
The study is being conducted at the Heart Center Siegburg, Siegburg, Germany under the direction of Professor Eberhard Grube; at Krankenhaus de Barmh Bruder, Trier, Germany under the direction of Dr. Karl-Eugen Hauptmann; and at the Institute Dante Pazzanese of Cardiology, Brazil under the direction of Dr. Alexandre Abizaid. Data analysis and management will be conducted by the Cardiovascular Research Foundation, based in New York City.
Suppression of neointimal hyperplasia, the underlying cause of in-stent restenosis, by 17(beta)-estradiol released from the stent surface, represents a novel approach for drug eluting stents and is the basis for the ETHOS I and ETHOS II clinical studies. Estrogens are known to inhibit smooth muscle cell proliferation and to accelerate endothelial regeneration, suggesting that estrogen coated stents may reduce restenosis in human coronary arteries. This was previously demonstrated in the 30 patient EASTER registry trial, using a non-optimized drug delivery system.
About X-Cell Medical
X-Cell Medical is discovering and developing next generation drugs for the medical device industry. X-Cell is applying its multi-disciplinary expertise in drug discovery, formulation, delivery and clinical development to bring advances in biotechnology to the interventional cardiology marketplace. The Company is currently focusing on the local and targeted delivery of drugs with superior safety and efficacy profiles for cardiovascular indications including restenosis, myocardial infarction and vulnerable plaque.
Located in Princeton, New Jersey, X-Cell Medical is backed by leading venture capitalists and the most influential cardiology device users in the industry. X-Cell's lead compound, 17(beta)-estradiol, is presently being tested in the ETHOS I clinical trial. More information is available on the Net: http://www.x-cellmedical.com.
Source: X-Cell Medical
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