The Pharmaceutical Journal
Vol 276 No 7396 p431
15 April 2006

This article
Reprint   Photocopy

  Acrobat Reader

News summary

Possibility of cytokine storm in TGN1412 trial was considered

Consideration was given to the possibility of TGN1412 causing a cytokine storm before approval of the clinical trial that resulted in six men being admitted to intensive care last month, the Medicines and Healthcare products Regulatory Agency acknowledged this week.

“The clinical trial documents show that the theoretical possibility of cytokine storm was considered; reasons are given why it was unlikely to happen with TGN1412,” an MHRA spokesman said. The trial documents describe the high level of correlation of occurrence of cytokine storms between non-human primates and humans in trials involving a different, but similar, product. “This suggests that animal testing should provide an indication of the degree of risk for cytokine storm occurring in humans,” the spokesman explained.

“What was unprecedented in this case was the severity of the reaction in humans, at such a low dose, when the indication from animal testing was that the risk was very low,” he added. “In fact, there was no evidence of a cytokine storm at any dose given to non-human primates, up to 500 times the initial dose given to humans.”