Back to Search Start Over

Improving the Assessment of Risk Factors Relevant to Potential Carcinogenicity of Gene Therapies: A Consensus Article.

Authors :
Klapwijk, Jan C.
Del Rio Espinola, Alberto
Libertini, Silvana
Collin, Philippe
Fellows, Mick D.
Jobling, Susan
Lynch, Anthony M.
Martus, HansJoerg
Vickers, Catherine
Zeller, Andreas
Biasco, Luca
Brugman, Martijn H.
Bushmann, Frederic D.
Cathomen, Toni
Ertl, Hildegrund C.J.
Gabriel, Richard
Gao, Guangping
Jadlowsky, Julie K.
Kimber, Ian
Lanz, Thomas A.
Source :
Human Gene Therapy. Aug2024, Vol. 35 Issue 15/16, p527-542. 16p.
Publication Year :
2024

Abstract

Regulators and industry are actively seeking improvements and alternatives to current models and approaches to evaluate potential carcinogenicity of gene therapies (GTs). A meeting of invited experts was organized by NC3Rs/UKEMS (London, March 2023) to discuss this topic. This article describes the consensus reached among delegates on the definition of vector genotoxicity, sources of uncertainty, suitable toxicological endpoints for genotoxic assessment of GTs, and future research needs. The collected recommendations should inform the further development of regulatory guidelines for the nonclinical toxicological assessment of GT products. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
10430342
Volume :
35
Issue :
15/16
Database :
Academic Search Index
Journal :
Human Gene Therapy
Publication Type :
Academic Journal
Accession number :
179063481
Full Text :
https://doi.org/10.1089/hum.2024.033