The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.
The Northwick Park tragedy ? protecting healthy volunteers in future first-in-man trials
Open accessAbstract
The development of potentially powerful drugs which may become effective in the treatment for disorders currently difficult to manage presents the pharmaceutical industry and the scientific community with a major challenge. Such drugs with novel modes of action and the capacity to modify the body's immune system could also be very toxic. The possibility became a tragic reality on March 13th 2006 when TGN1412 was given to six healthy volunteers at Northwick Park hospital. All six became seriously ill. Fortunately none died but some were left with serious residual defects. The British Secretary of State for Health set up an Expert Scientific Group to investigate this tragic event. The report had to make recommendations designed to prevent a recurrence whilst not unduly delaying or discouraging the development of new drugs designed to treat cancers and other serious disorders. They made 22 recommendations. The drug TGN1412 had been shown to be well tolerated by non-human primates. A recent report on non-human primates in research recommended their continued use in some forms of research, for example on brain disorders. However, they also recommended that non-human primates should be used sparingly and only when justified scientifically. Their treatment should be optimal and research on them should be restricted to selected centres of expertise. The tragedy at Northwick Park should encourage the Pharmaceutical Industry to rethink their use of non-human primates in drug toxicity testing and hopefully to reduce their use and treat them better.
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“Nine of the 22 recommendations put forward by the ESG related to study design, including initial dosing of drug.”
From The calm after the cytokine storm: lessons from the TGN1412 trial (2008) · cites this paper as [9]
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“The ESG made 22 recommendations, encompassing various aspects of the drug development process (9).”
From The calm after the cytokine storm: lessons from the TGN1412 trial (2008) · cites this paper as [9]
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Cites
Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412
Suntharalingam, G., Perry, M. R., Ward, S., Brett, S. J., Castello-Cortes, A., Brunner, M. D., & Panoskaltsis, N. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa063842 · Cited by 2,164
The CD28 family: a T-cell rheostat for therapeutic control of T-cell activation
Riley, J. L., & June, C. H. (2004) · Blood · doi:10.1182/blood-2004-04-1596 · Cited by 326
Beyersdorf, N., Gaupp, S., Balbach, K., Schmidt, J., Toyka, K. V., Lin, C.-H., Hanke, T., Hünig, T., Kerkau, T., & Gold, R. (2005) · The Journal of Experimental Medicine · doi:10.1084/jem.20051060 · Cited by 203
Lühder, F., Huang, Y., Dennehy, K. M., Guntermann, C., Müller, I., Winkler, E., Kerkau, T., Ikemizu, S., Davis, S. J., Hanke, T., et al. (2003) · The Journal of Experimental Medicine · doi:10.1084/jem.20021024 · Cited by 193
Crystal structure of a soluble CD28-Fab complex
Evans, E. J., Esnouf, R. M., Manso-Sancho, R., Gilbert, R. J. C., James, J. R., Yu, C., Fennelly, J. A., Vowles, C., Hanke, T., Walse, B., et al. (2005) · Nature Immunology · doi:10.1038/ni1170 · Cited by 180
Establishing risk of human experimentation with drugs: lessons from TGN1412
Kenter, M., & Cohen, A. (2006) · The Lancet · doi:10.1016/s0140-6736(06)69562-7 · Cited by 153
Schmidt, J., Elflein, K., Stienekemeier, M., Rodriguez-Palmero, M., Schneider, C., Toyka, K. V., Gold, R., & Hünig, T. (2003) · Journal of Neuroimmunology · doi:10.1016/s0165-5728(03)00182-6 · Cited by 59
Dennehy, K. M. (2003) · International Immunology · doi:10.1093/intimm/dxg063 · Cited by 36
The use of non-human primates in research : a working group report
Weatherall, D. (2006) · Europe PMC (PubMed Central) · Cited by 20
Experts back research using primates
Day, M. J. (2006) · BMJ · doi:10.1136/bmj.39063.532917.db · Cited by 3
Research works printed but not linked: 2
- Duff G, 2006, Expert Scientific Group Phase One Clinical Trials Final Report
- Day M, 2005, BMJ, 7581, 1235
Cited by
Cytokine release assays: Current practices and future directions
Finco, D., Grimaldi, C., Fort, M., Walker, M., Kiessling, A., Wolf, B., Salcedo, T., Faggioni, R., Schneider, A., Ibraghimov, A., et al. (2014) · Cytokine · doi:10.1016/j.cyto.2013.12.009 · Cited by 106
The calm after the cytokine storm: lessons from the TGN1412 trial
St. Clair, E. W. (2008) · Journal of Clinical Investigation · doi:10.1172/jci35382 · Cited by 79
Safety of biologics, lessons learnt from TGN1412
Stebbings, R., Poole, S., & Thorpe, R. (2009) · Current Opinion in Biotechnology · doi:10.1016/j.copbio.2009.10.002 · Cited by 70
Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412
Dayan, C. M., & Wraith, D. C. (2008) · Clinical and Experimental Immunology · doi:10.1111/j.1365-2249.2007.03559.x · Cited by 28
Metadata
- Authors
- Dowsing, T., & Kendall, M. J.
- Affiliations
- University of Warwick (GB)
- University of Birmingham (GB)
- Venue
- Journal of Clinical Pharmacy and Therapeutics
- Publisher
- Hindawi Limited
- Published
- 2007-06
- Volume
- 32
- Issue
- 3
- Pages
- 203-207
- ISSN
- 0269-4727 (ISSN-L)
- 1365-2710
- OpenAlex
- W2135143929
- Cited by
- 25
- References
- 10
- Citations by year
- 2024: 2 · 2021: 1 · 2020: 1 · 2019: 1 · 2016: 3 · 2015: 2 · 2014: 2 · 2013: 3
- FWCI
- 3.09
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Pharmacy and Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Keywords
- TGN1412, healthy volunteers, drug toxicity, non-human primates, animal experimentation, drug development, regulatory recommendations, adverse drug reactions, immunomodulators
- MeSH terms
- Adult, Animals, Antibodies, Monoclonal, Clinical Trials as Topic, Hospitals, Humans, Injections, Intravenous, London, Macaca fascicularis, Male, Societies, Guidelines as Topic, Risk Assessment, Models, Animal, Antibodies, Monoclonal, Humanized, Drug-Related Side Effects and Adverse Reactions
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- Dowsing, T., & Kendall, M. J. (2007). The Northwick Park tragedy ? protecting healthy volunteers in future first-in-man trials. Journal of Clinical Pharmacy and Therapeutics. https://doi.org/10.1111/j.1365-2710.2007.00808.x
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
