Drug trial victims suffered ‘immune storm’

All six men who became seriously ill after taking part in the Tegenero TGN1412 trials conducted at Northwick Park Hospital in March this year suffered from a rapid immune system overreaction known as a Cytokine storm, the doctors who treated them have reported.

Publishing their work in the August 14th online edition of the New England Journal of Medicine, the doctors claim that the cases could offer an insight into systematic inflammatory responses.

During the phase one trials, within 90 minutes of taking the TGN1412 drug, a monoclonal antibody that directly stimulates T cells, the six men suffered from symptoms including headaches, nausea, diarrhoea, lower back pain and hypertension.

“At around 12 hours one of the patients became severely unwell and it was at that point that we made the decision that we should admit all six of them [into intensive care] in case the other five deteriorated,” said Dr Ganesh Suntharalingam, the clinical director of intensive care at the hospital and co-author of the report.

“16 hours after the drug infusion they did in fact all start to develop worsening symptoms and another lab analysis showed that they had a severe inflammatory disorder.”

After this time two patients became so ill that they required intensive organ support for eight to 16 days.

Despite the presence of the Cytokine storms all six men survived. However, they suffered multiple organ failure and one of the six victims has had early signs of cancer detected in his blood.

Dr Suntharalingam added that people running clinical trials should be aware of the potential dangers.

“There are clearly going to be more trials of new drugs in field of molecular biology,” he said.

The Expert Scientific Group, convened by the health secretary, is currently conducting a report into the trial and has advised a number of steps to improve clinical trials in its interim report. A final report is expected this autumn once it has completed its work.

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