title: An update on TGN1412.
abstract: In the last issue of ATLA, we assessed whether the existing methods for assessing the safety and efficacy of new candidate medicines was adequate for the testing of humanised therapeutic agents. We made specific reference to the failed TGN1412 first-in-man study that took place earlier this year. This paper was circulated to experts and those involved in the development or testing of TGN1412. More recently, the Focus on Alternatives group has made a submission to the Expert Working Group that is currently considering how such incidences can be avoided in the future. Here, we provide an update of the events relating to the TGN1412 clinical trial.
authors.affiliation: FRAME, Nottingham, NG1 4EE, UK. Nirmala@frame.org.uk
authors.forename: Nirmala
authors.initials: N
authors.lastname: Bhogal
authors.forename: Robert
authors.initials: R
authors.lastname: Combes
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000494:pharmacology; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000941:ethics / Q000379:methods*; D006801:Humans; D008252:Macaca fascicularis; D008253:Macaca mulatta; D033281:Nontherapeutic Human Experimentation / Q000941:ethics
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C509303:TGN-1412