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- TGN1412 abstract "TGN1412 (also known as CD28-SuperMAB) is the working name of an immunomodulatory drug which was withdrawn from development after inducing severe inflammatory reactions in the first-in-man study in London in March 2006. The developing company, TeGenero Immuno Therapeutics, entered into insolvency proceedings later that year.Originally intended for the treatment of B cell chronic lymphocytic leukemia (B-CLL) and rheumatoid arthritis, TGN1412 is a humanised monoclonal antibody that not only binds to, but is a strong agonist for, the CD28 receptor of the immune system's T cells. CD28 is the co-receptor for the T cell receptor; It binds to receptors on the interacting partner in the reaction through one of its ligands (B7 family).In its first human clinical trials, it caused catastrophic systemic organ failure in the subjects, despite being administered at a supposed sub-clinical dose of 0.1 mg per kg; some 500 times lower than the dose found safe in animals. Six volunteers were hospitalized on 13 March 2006, at least four of these suffering from multiple organ dysfunction. Tentative opinions from an as-yet uncompleted inquiry suggest that the problems resulted from "unforeseen biological action in humans", rather than breach of trial protocols, and the case therefore has had important ramifications for future trials of potentially powerful clinical agents.Scientists in early 2007 put forth the theory that the drug acted in a different fashion in humans as compared with the laboratory animals in which the drug was first tried. The severe reactions in humans could have only occurred, they believe, in animals with memory T lymphocytes. Animals raised in a sterile lab would presumably have no 'memory' of previous illnesses, thus would not exhibit the severe reactions that occurred in the human subjects. However this is a misunderstanding of the research: the research says that non-human animals studied have fewer memory T cells than humans, and that stimulation through the CD28 receptor alone in memory T cells causes them to infiltrate organs and also activates them.The drug, which was designated as an orphan medical product by the European Medicines Agency in March 2005, was developed by TeGenero Immuno Therapeutics, tested by Parexel and manufactured by Boehringer-Ingelheim. TeGenero announced the first elucidation of the molecular structure of CD28 almost exactly one year prior to commencement of the TGN1412 phase I clinical trial.".
- TGN1412 atcPrefix "none".
- TGN1412 thumbnail T_cell_activation.svg?width=300.
- TGN1412 wikiPageExternalLink 270.
- TGN1412 wikiPageExternalLink dispatches.htm.
- TGN1412 wikiPageExternalLink 440855a.
- TGN1412 wikiPageExternalLink 4914546.stm.
- TGN1412 wikiPageExternalLink 5015224.stm.
- TGN1412 wikiPageExternalLink perspectives.php.
- TGN1412 wikiPageExternalLink textdoc?DB=EPODOC&IDX=DE10345008&F=8&QPN=DE10345008.
- TGN1412 wikiPageExternalLink textdoc?DB=EPODOC&IDX=US2006009382&F=0&QPN=EP1600164&RPN=EP1600164&DOC=cca34af198500dc47b33f0ab732cd3a34a.
- TGN1412 wikiPageExternalLink textdoc?DB=EPODOC&IDX=US2006009382&F=0&QPN=US2006009382&RPN=US2006009382&DOC=dcb66f26dd9a5108c88241fac27a21f198.
- TGN1412 wikiPageExternalLink 070122-10.html.
- TGN1412 wikiPageID "4402358".
- TGN1412 wikiPageRevisionID "588562475".
- TGN1412 atcPrefix "none".
- TGN1412 hasPhotoCollection TGN1412.
- TGN1412 legalStatus "never marketed".
- TGN1412 mabType "mab".
- TGN1412 molecularWeight "~148 kDa".
- TGN1412 pregnancyCategory "N/A".
- TGN1412 routesOfAdministration Intravenous_therapy.
- TGN1412 source "zu/o".
- TGN1412 target CD28.
- TGN1412 type "mab".
- TGN1412 verifiedrevid "448717516".
- TGN1412 subject Category:2006_in_London.
- TGN1412 subject Category:All_articles_with_unsourced_statements.
- TGN1412 subject Category:Health_disasters.
- TGN1412 subject Category:Monoclonal_antibodies.
- TGN1412 subject Category:Unnamed_monoclonal_antibodies.
- TGN1412 type Drug.
- TGN1412 type FunctionalSubstance.
- TGN1412 comment "TGN1412 (also known as CD28-SuperMAB) is the working name of an immunomodulatory drug which was withdrawn from development after inducing severe inflammatory reactions in the first-in-man study in London in March 2006.".
- TGN1412 label "TGN1412".
- TGN1412 label "TGN1412".
- TGN1412 label "TGN1412".
- TGN1412 label "TGN1412".
- TGN1412 sameAs TGN1412.
- TGN1412 sameAs TGN1412.
- TGN1412 sameAs TGN1412.
- TGN1412 sameAs m.0c09yn.
- TGN1412 sameAs Q424452.
- TGN1412 sameAs Q424452.
- TGN1412 wasDerivedFrom TGN1412?oldid=588562475.
- TGN1412 depiction T_cell_activation.svg.
- TGN1412 isPrimaryTopicOf TGN1412.