Journal
CURRENT OPINION IN BIOTECHNOLOGY
Volume 20, Issue 6, Pages 673-677Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.copbio.2009.10.002
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In 2006, a first-in-man phase-I clinical trial of an immunomodulatory mAb,TGN1412, ended in disaster when six healthy recipients suffered a life-threatening systemic inflammatory response, termed a 'Cytokine Storm'. A subsequent investigation concluded that these serious adverse events, not predicted by pre-clinical safety testing, were unforeseen biological effects in man. However, the adverse events had been exacerbated by administration of a near-maximum immuno-stimulatory dose to volunteers, because the calculation of a safe starting dose in man had been based upon results from pre-clinical safety testing in a non-responsive species. In hindsight, many lessons have been learnt from this experience and these have prompted a revision of the European guidelines for first-in-man phase-I clinical trials of biologics. Perhaps the most important lesson is that greater caution needs to be exercised when evaluating new biologics.
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