Healthcare Industry News: estradiol
News Release - March 8, 2006
X-Cell Medical Initiates Enrollment for ETHOS II Clinical Trial of Estradiol Eluting StentPRINCETON, N.J.--(HSMN NewsFeed)--March 8, 2006--X-Cell Medical, Inc. announced today that the Company has initiated enrollment in its multinational clinical trial to study the safety and effectiveness of the ETHOS (estradiol eluting stents in Humans for restenOSis) II 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. 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 2H 2006.
"ETHOS II was designed as part of our ongoing commitment to create a DES system with superior safety characteristics. In this regard, the X-Cell team is pleased to offer this potential enhancement of our proprietary ETHOS technology in the ETHOS II trial," said X-Cell Medical President and CEO, Dr. Oded Ben-Joseph. "We continue to believe that the overall safety of existing DES products remains a concern and are hopeful that the ETHOS system, with a new drug class in this market, will address this important issue," added Ben-Joseph.
Steve Peltier, X-Cell's Executive Director of Regulatory Affairs provided an update on the ongoing ETHOS I trial, "Our clinical investigators continue to report positive outcomes at the time of implantation across a broad range of patients with coronary artery disease. Following a preliminary review of the 30-day follow-up data, there have been no reports of major adverse cardiac events. This early data continues to support the growing evidence of the safety and effectiveness of estradiol seen in earlier clinical trials."
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 clinical studies. This was previously demonstrated in the 30 patient EASTER registry trial, using a non-optimized drug delivery system. Estrogen inhibits smooth muscle cell proliferation and accelerates endothelial regeneration, suggesting that estrogen coated stents may reduce restenosis while enhancing other safety parameters such as sub-acute and late thrombosis, in human coronary arteries.
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
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.