Reproductive and developmental toxicology studies with gantenerumab in PS2APP transgenic mice

被引：8

作者：

Barrow, Paul ^{[1
]}

Villabruna, Loris ^{[1
]}

Hoberman, Alan ^{[2
]}

Bohrmann, Bernd ^{[1
]}

Richter, Wolfgang F. ^{[1
]}

Schubert, Christine ^{[1
]}

机构：

[1] F Hoffmann La Roche Ltd, Roche Pharmaceut Res & Early Dev, Basel, Switzerland

[2] Charles River Labs, Horsham, PA USA

来源：

REPRODUCTIVE TOXICOLOGY | 2017年 / 73卷

关键词：

Safety testing; Dart; Monoclonal antibody; Disease model; PS2APP mouse; AMYLOID DEPOSITION; ALZHEIMER-DISEASE; SAFETY ASSESSMENT; BIOPHARMACEUTICALS; BETA; AGE;

D O I：

10.1016/j.reprotox.2017.07.014

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Gantenerumab is intended for the treatment of Alzheimer's disease. It is a fully human recombinant monoclonal IgG1 which binds aggregated forms of amyloid beta such as A beta oligomers, fibrils and neuritic amyloid plaques. A full package of developmental and reproductive toxicity (DART) studies was performed in the PS2APP double-transgenic mouse model of Alzheimer's disease. A combined fertility and embryo fetal development study and a pre-and post-natal development study were performed. The PS2APP mouse model allowed a more complete DART evaluation than would have been possible in conventional species or strains which do not express the target antigen of gantenerumab. No developmental or reproductive hazards were identified. (C) 2017 Elsevier Inc. All rights reserved.

引用

页码：362 / 371

页数：10

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