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New research on safety of intracoronary delivery of adenovector reported in cover story of Molecular Therapy

ic genes in man at least using Collaterals intracoronary route of administration, said Jeffrey Friedman, M.D. vice president of development of Collateral Therapeutics. In particular, it provides important data which reinforces our prior views about the apparent safety of Collaterals proprietary approach of intracoronary delivery of genes to enhance angiogenesis as well as improve heart function. Furthermore, our unique approach allows delivery of genes at the time of cardiac catheterization without causing injury to the heart as in other techniques that require the heart to be punctured in order to deliver a therapeutic gene.

In the U.S., the adenoviral vector has been used in approximately one third of all gene therapy clinical trials, with adenovirus serotype 5 being the most widely used. These adenoviral vectors have now been used in investigational studies designed to evaluate the safety and efficacy of gene therapy in patients with cancer, cardiovascular disease and inherited disorders. According to the Office of Biotechnology Activities, National Institutes of Health, in the past decade, approximately 144 gene therapy clinical trials using adenoviral vectors have been conducted and of all patients who have participated in gene therapy trials, nearly 1 in 5 patients has been administered an adenoviral vector, said Christopher J. Reinhard president and chief operating officer of Collateral Therapeutics. Our lead product candidate, GENERX, uses the adenovirus serotype 5 to administer human growth factor, FGF-4, for the potential treatment of stable angina due to coronary artery disease. We are excited about these new studies, which further support the growing body of knowledge regarding the safety profile of adenoviral vectors for cardiovascular gene therapy, and we are pleased with the clinical progression of GENERX.

GENERX, a non-surgical angiogenic gene therapy, is being developed by Schering AG, Germany (NYSE: SHR) under an agreement wi
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Contact: Lora Pike
lpike@collateralthx.com
858-794-3410
Collateral Therapeutics
1-Dec-2001


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