Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412
- PMID: 18190459
- PMCID: PMC2276942
- DOI: 10.1111/j.1365-2249.2007.03559.x
Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412
Abstract
Current immunology research is generating many new approaches to immunotherapy. However, the recent disaster surrounding the testing of TGN1412, has unsettled regulators and the pharmaceutical industry regarding new immunotherapies and highlighted the complexities of conducting clinical trials with agents that target the immune system. Here we discuss the critical role for immunologists in ensuring that the development of new immunotherapies continues.
References
- 
    - Keymeulen B, Vandemeulebroucke E, Ziegler AG, et al. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005;352:2598–608. - PubMed
 
- 
    - Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med. 2006;355:1018–28. - PubMed
 
- 
    - Kenter MJH, Cohen AF. Establishing the risk of human experimentation with drugs: lessons from TGN 1412. Lancet. 2006;368:1387–91. - PubMed
 
- 
    - Royal Statistical Society. Report of the working party on statistical issues in first-in-man studies. London: Royal Statistical Society; 2007. - PubMed
 
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
- Full Text Sources
 
        