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Improving the Assessment of Risk Factors Relevant to Potential Carcinogenicity of Gene Therapies: A Consensus Article.
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; Levine, Bruce L; Micklethwaite, Kenneth P; Onodera, Masafumi; Pizzurro, Daniella M; Reed, Simon; Rothe, Michael; Sabatino, Denise E; Salk, Jesse J; Schambach, Axel; Themis, Michael; Yuan, Jing.
Affiliation
  • Klapwijk JC; Cornelis Consulting Ltd, London, United Kingdom.
  • Del Rio Espinola A; GentiBio Inc., Cambridge, Massachusetts, USA.
  • Libertini S; Novartis Biomedical Research, Basel, Switzerland.
  • Collin P; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
  • Fellows MD; Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
  • Jobling S; TestaVec Ltd, Maidenhead, United Kingdom.
  • Lynch AM; Division of Biosciences, Department of Life Sciences, College of Health and Life Sciences, Brunel University London, Uxbridge, United Kingdom.
  • Martus H; GlaxoSmithKline, Genetic Toxicology, Ware, United Kingdom.
  • Vickers C; Novartis Biomedical Research, Basel, Switzerland.
  • Zeller A; National Centre for the Replacement Refinement and Reduction of Animals in Research, London, United Kingdom.
  • Biasco L; F. Hoffmann-La Roche Ltd., pRED, Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
  • Brugman MH; UCL Zayed Centre for Research (ZCR), London, United Kingdom.
  • Bushmann FD; Cell and Gene Therapy, GSK Medicine Research Centre, Stevenage, United Kingdom.
  • Cathomen T; Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Pennsylvania, Pennsylvania, USA.
  • Ertl HCJ; Institute for Transfusion Medicine and Gene Therapy, Medical Center- University of Freiburg, Freiburg, Germany.
  • Gabriel R; Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • Gao G; Ertl Laboratory, Vaccine & Immunotherapy Center, The Wistar Institute, Philadelphia, Pennsylvania, USA.
  • Jadlowsky JK; ProtaGene CGT, Heidelberg, Germany.
  • Kimber I; Horae Gene Therapy Center, UMass Chan Medical School, University of Massachusetts, Worcester, Massachusetts, USA.
  • Lanz TA; Center for Cellular Immunotherapies and Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • Levine BL; Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom.
  • Micklethwaite KP; Drug Safety Research & Development, Pfizer, Inc., Groton, Connecticut, USA.
  • Onodera M; Center for Cellular Immunotherapies and Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • Pizzurro DM; Department of Haematology, Blood Transplant and Cell Therapies Program, Westmead Hospital, Sydney, Australia.
  • Reed S; NSW Health Pathology Blood Transplant and Cell Therapies Laboratory - ICPMR Westmead, Sydney, Australia.
  • Rothe M; Westmead Institute for Medical Research, Sydney, Australia.
  • Sabatino DE; Sydney Medical School, The University of Sydney, Sydney, Australia.
  • Salk JJ; Gene & Cell Therapy Promotion Center, National Center for Child Health and Development, Tokyo, Japan.
  • Schambach A; Merck & Co., Inc., Boston, Massachusetts, USA.
  • Themis M; Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, United Kingdom.
  • Yuan J; Institute of Experimental Hematology, Hannover Medical School, Hannover, Germany.
Hum Gene Ther ; 35(15-16): 527-542, 2024 Aug.
Article de En | MEDLINE | ID: mdl-39049734
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.
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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Thérapie génétique Limites: Animals / Humans Langue: En Journal: Hum Gene Ther Sujet du journal: GENETICA MEDICA / TERAPEUTICA Année: 2024 Type de document: Article Pays d'affiliation: Royaume-Uni Pays de publication: États-Unis d'Amérique
Texte intégral
Ajouter à My VHL
Imprimer
XML
PubMed Links
Recherche sur Google

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Thérapie génétique Limites: Animals / Humans Langue: En Journal: Hum Gene Ther Sujet du journal: GENETICA MEDICA / TERAPEUTICA Année: 2024 Type de document: Article Pays d'affiliation: Royaume-Uni Pays de publication: États-Unis d'Amérique