The Lethal Drug Trial That Turned Men Into Elephants

Summary by Krater

A documentary dramatization following the 2006 TGN1412 clinical drug trial in London where six healthy male volunteers suffered multiple organ failure due to an unprecedented cytokine storm.

From the video

Answers: What happened during the 2006 TGN1412 drug trial disaster at Northwick Park Hospital?

• clinical drug trials
• monoclonal antibodies
• Phase 1 human trials
• TGN1412 drug trial
• cytokine release syndrome
• Northwick Park Hospital

What it concludes

• The TGN1412 drug trial disaster occurred because the drug was administered ten times quicker into the human bloodstream than it had been in monkey studies.
• The independent report concluded that the adverse effects were the result of an unpredictable biological action of the drug in humans.
• The MHRA report and subsequent investigations recommended that high-risk trials should take place within a hospital with access to intensive care.
• In 2013, TGN1412 successfully passed Phase One human trials in Russia under the name TAB08 using 0.1% of the antibody dose and infusing it 40 times more slowly.