Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8552693 | Reproductive Toxicology | 2017 | 29 Pages |
Abstract
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 Aβ 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.
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Authors
Paul Barrow, Loris Villabruna, Alan Hoberman, Bernd Bohrmann, Wolfgang F Richter, Christine Schubert,