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X-Cell Medical Commences Randomized Clinical Trial of Estradiol Eluting Stent

Posted on: Wednesday, 17 August 2005, 09:00 CDT

X-Cell Medical, Inc. announced today that it has commenced a multinational clinical trial to study the safety and effectiveness of 17(beta)-estradiol stents coated with slow-release and moderate-release formulations, the ETHOS I Coronary Stent System. Estradiol, an approved and safe drug used in hormone replacement therapy and other indications, represents a novel and potentially safer approach to reducing restenosis in human coronary arteries.

"We are optimistic that the enhanced endothelial growth and the anti-restenotic properties of estradiol, will provide patients with coronary artery disease a safer alternative to current treatments, particularly in light of thrombosis concerns reported in recent trials," said X-Cell Medical President and CEO, Dr. Oded Ben-Joseph. "X-Cell's strategy is to rapidly advance a pipeline of next generation, proprietary cardioprotective drugs for the $7 billion drug eluting stent industry".

"The integration of an excellent stent delivery platform, a safe biostable polymer release system, and a pro-healing FDA-approved drug should provide the potential for rapid entry into the DES marketplace," says X-Cell Medical Director Martin B. Leon, MD from Columbia University Medical Center and the Cardiovascular Research Foundation.

About the ETHOS I study

ETHOS I is a three-center, randomized, double-blind, prospective study that will be followed by an open label phase during which patients will receive the optimal elution profile. The study will eventually include 150 patients once the optimal release formulation has been chosen. The study will compare the ETHOS I drug-eluting stent (DES) with 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. The study is being conducted at the Heart Center Siegburg, Siegburg, Germany under the direction of Prof. Eberhard Grube; at Krankenhaus de Barmh. Brueder, 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, NY.

X-Cell Medical Executive Director of Clinical and Regulatory Affairs, Mr. Steve Peltier said, "The investigators are very motivated to begin enrolling study patients. We've found they are as keen as we are to understand the potential of ETHOS I in the treatment of restenotic coronary artery lesions."

About Estradiol

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 clinical study. 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 a leader in the discovery and development of next generation drugs for use in combination with coronary and peripheral stents to address cardiovascular needs. The company has developed unique expertise in the industry and its programs are focused on the development of novel drugs with superior safety profiles. The company was founded in 2003 by Accelerated Technologies, a group consisting of leading cardiologists and several investment funds. X-Cell has established a management/scientific team with multi-disciplinary expertise in drug discovery, formulation and polymer coatings, and drug development, backed by an advisory board of the most influential cardiology device users in the industry.

For more information visit www.x-cellmedical.com.

Source: Business Wire

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