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BONUS: The Case of a Clinical Trial Catastrophe - The TGN1412 ‘Elephant Men’ Clinical Trial
This episode is a little different. Today's episode is a story looking at the case of the TGN1412 CIinical Trial. A trial that went terribly wrong.
I thoroughly enjoyed making this episode and have a number of ideas for similar ones. If you liked this bonus episode, please leave a 5 star rating so that I know you're interested to hear more in future.
In March of 2006, a clinical trial for the drug TGN1412 gathered eight young and healthy men as volunteers. Within a mere 16 hours, all six were urgently transferred to Northwick Park Hospital's intensive care unit due to severe and life-threatening reactions.
This catastrophic event, now infamously known as the 'Elephant Man Drug Trial,' sent shockwaves rippling through the medical and pharmaceutical communities. TGN1412, a groundbreaking monoclonal antibody drug developed by TeGenero, a German biotech company, had held the promise of treating autoimmune diseases and leukemia. Paraxel, a prominent contract research organization, was responsible for conducting the Phase I trial, the critical first-in-human testing, within an independent clinical trials unit at Northwick Park.
Prior to the trial, comprehensive clinical and animal testing, including studies involving non-human primates, had been diligently carried out. These preliminary tests had seemingly indicated no signs of safety issues.
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Contact me: christiana@globalhealthwriter.com
Expert group on Clinical Trials report: Duff GW, et al. (Expert Group on Phase One Clinical Trials) (7 December 2006). Expert Group on Phase One Clinical Trials: Final report (Report).
Excellent, open-access paper looking at the biochemical phenomenon behind this case. Revisiting CD28 Superagonist TGN1412 as Potential Therapeutic for Pediatric B Cell Leukemia: A Review
*Correction: The compensation that the 6 affected participants received was £2mil to be split between the 6 participants.