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TGN1412 trial protocol in line, says MHRA

UK regulators have indicated that a clinical trial, which left six male volunteers in hospital, was carried out ìaccording to the agreed protocolî

UK regulators have indicated that a clinical trial, which left six male volunteers in hospital, was carried out ìaccording to the agreed protocolî.

The phase I safety trial of the drug, TGN 1412, a monoclonal antibody being developed to treat conditions including rheumatoid arthritis and leukaemia, was run by contract research organisation Parexel on behalf of German pharma company TeGenero AG.

The Medicines and Healthcare products Regulatory Agency (MHRA) said it had found no evidence to suggest that the drug had been contaminated or improperly manufactured.

ìThere are still further tests planned and until these are complete we cannot be firm about our conclusions,î said MHRA chief executive, Professor Kent Woods. ìHowever, if these findings were to be confirmed, it would indicate that this product showed a pharmacological effect in man which was not seen in pre-clinical tests in animals at much higher doses.î

He added that Health Secretary, Patricia Hewitt, has agreed to establish an international expert group to examine the trial.

Meanwhile, the lawyer representing four of the volunteers who fell ill has criticised Parexel and TeGenero for their response to his request for information about the tests.

Martin Day, of Leigh Day Solicitors, told the BBC that despite his writing nine times over the last few weeks to Parexel and TeGenero, one firm had refused ìpoint blankî to meet him, while the other had simply not responded.

He said he would go through the courts to force them to divulge the information if they were not forthcoming.

30th September 2008

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