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

SAN DIEGO, California December 3, 2001 Collateral Therapeutics, Inc. (Nasdaq: CLTX) announced that preclinical in vitro and in vivo results reported in the December 2001 issue of Molecular Therapy showed that male reproductive cells (germ cells) were unaffected following intracoronary delivery of Collaterals adenovector (adenovirus serotype 5 Ad5). These findings confirm other research studies in which potential risks associated with inadvertent germ line transmission following adenoviral administration have been shown to be highly unlikely.

In the study, led by Robert E. Braun, Ph.D. Associate Professor of Genetics at the University of Washington, gene expression after adenovirus delivery was analyzed from a series of both in vitro and in vivo studies. The in vitro studies demonstrated that germ cells grown in cell culture were refractory to infection by Collaterals adenovector. To assess the risk of germ line transmission in vivo, researchers used a mouse model to deliver human recombinant Ad5 carrying a germ cell-specific promoter fused to a reporter gene directly into the left ventricular cavity of the heart. They observed that the reporter gene protein was not expressed in developing spermatids or mature sperm, with analyses performed at multiple time points after administration to evaluate all major stages of germ cell development. Importantly, the in vivo studies did not detect infection of the reproductive stem cells. The positive results from these studies are consistent with other recent studies using different models and routes of delivery. However, this is the first study that directly assessed the ability of an adenovirus to result in gene expression in extremely large numbers (i.e., millions) of germ line cells, and the first to assay infection of the reproductive stem cell population.

This study provides significant new information further supporting the safety of the use of the adenovirus as a vehicle to deliver therapeut
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Contact: Lora Pike
lpike@collateralthx.com
858-794-3410
Collateral Therapeutics
1-Dec-2001


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