Expert says TGN1412 tests were ‘more dangerous than usual’

The drug trials that left six men in hospitalised in March may have been more dangerous that typical experiments, according to one expert.

Professor Sir Gregory Winter, from the laboratory of molecular biology at Cambridge University, said that there were questions over whether or not the results of the trials for TeGenero’s TGN1412 drug, which caused a massive immune system overreaction in the trial participants, could have been predicted.

He told BBC Radio Four’s PM programme: “I am not saying these experiments should not have been done, but I am starting from the principle that this was probably a lot more dangerous than the typical experiments that are done with antibodies in clinical [trials].”

“I do not think this is hindsight, in fact I personally would have expected to have seen the kind of response that those patients had,” he concluded.

Dr David Glover, a member of the investigation team, added: “In simple terms the effect may have been able to be anticipated and predicted. The unfortunate thing is the tests that were done appear not to have predicted things.”

TGN1412 is an immunomodularity drug designed to treat lymphocytic leukaemia and rheumatoid arthritis. The drug caused massive swelling similar to angioedema, according to reports. TeGenero said the hospitalisations were completely unexpected and that the drug had been accepted well by animals in testing.

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