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Tests developed to make stage I trials safer

Scientists have developed new preclinical tests that show how the clinical trial disaster at Northwick Park hospital (PJ, 25 March 2006, p342) could have been prevented.

Standard preclinical tests did not predict the catastrophic reaction that ensued when the immunotherapy drug TGN1412 was administered to healthy volunteers.

“With hindsight testing this drug in man was a mistake, but at the time the standard required pre-clinical tests failed to predict the effects it would have on the six volunteers,” said Stephen Poole at the British Pharmacological Society’s meeting in Brighton on 15 December 2008.

Dr Poole and his colleagues from the National Institute for Biological Standards and Control reproduced in vitro the reaction suffered by the volunteers.

The preclinical work highlighted that it is important to ensure such drugs are not tested solely on immune cells in isolation and that having a mixed human cell culture of white blood cells and endothelial cells is a much better indicator of how this type of drug will react in vivo.

The scientists have also developed a technique that dries the drug onto a plastic surface, rather than testing it on cells as a solution in water, which they say has proven to be a more reliable indicator of how the drug will react in the human body.

However the research is still early, Dr Poole pointed out, and the reasons why the drug had such an adverse event in the clinic but not in preclinical studies are yet to be fully determined.

Citation: The Pharmaceutical Journal URI: 10043679

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