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Safety of biologics, lessons learnt from TGN1412

Paper ID Volume ID Publish Year Pages File Format Full-Text
16554 42508 2009 5 PDF Available
Title
Safety of biologics, lessons learnt from TGN1412
Abstract

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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Publisher
Database: Elsevier - ScienceDirect
Journal: Current Opinion in Biotechnology - Volume 20, Issue 6, December 2009, Pages 673–677
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
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