The Pharmaceutical Journal
Vol 277 No 7423 p473
21 October 2006

This article
Reprint   Photocopy

  Acrobat Reader

News summary

Pre-trial data showed that TGN1412 was a high-risk compound

Information submitted to regulators showed that the compound used in the catastrophic Northwick Park trial in March was a high-risk compound unlikely to be suitable for administration to healthy people, a review claims (Lancet 2006;368:1387).

Researchers examined all the data available before the beginning of the trial of TGN1412 at Northwick Park Hospital, north London, a trial which led to six men being admitted to intensive care (PJ, 18 March, p307).

The risk analysis shows that essential information was absent and the antibody was a high-risk compound unlikely to be suitable for administration to healthy people without additional preclinical experiments. The researchers suggest that in vitro tests and a comparison of human, rhesus monkey, and cynomolgus monkey DNA sequences for the target of TGN1412 should have been included in the research file and, if not, should have led to questions from all involved in the clinical trial.