UK drug trial illnesses not due to errors - report

LONDON, May 26 (Reuters) A final report into a clinical trial of an experimental drug at a London hospital that left six men seriously ill found the adverse reactions they suffered were not due to errors in how the drug was made or tested.

Britain's Medicines Healthcare products Regulatory Agency (MHRA) said in the report released yesterday that an unexpected biological effect in humans was the most likely cause.

''We are satisfied that the adverse incidents which occurred were not as a result of any errors in the manufacture of TGN 1412, its formulation, dilution or administration to trial participants,'' MHRA Chief Executive Professor Kent Woods said in a statement.

He added that an independent group of experts will look into clinical trials involving similar types of drugs.

The trial of TGN 1412 was run by U.S. drug research company Parexel International Corp. on behalf of the German company TeGenero AG.

The conclusion is the same as the result of an interim report by the regulatory body released in April.

But in the final report the MHRA identified what it called ''good clinical practice'' discrepancies by Parexel in medical records and employment procedures.

The report said MHRA inspectors were not satisfied that the physician screening volunteers before the trial had adequate training and experience for the role. There was also no formal system in place to provide 24-hour medical cover.

No-one at Parexel was immediately available to comment.

The trial of TGN 1412 to treat chronic inflammatory conditions and leukaemia was immediately suspended after the men became violently ill at a London hospital in March.

One man is still being treated in the hospital.

TGN 1412, which belongs to a class of drugs known as monoclonal antibodies, targets and activates an immune system protein called CD28.

Dr Chris Higgins, the director of the Medical Research Council Clinical Services Centre, said it was reassuring that the report found no serious errors by Parexel and the MHRA.

''This does raise the issue, in retrospect, that when a completely new class of drug is tested there should be additional burden of proof regarding safety before it is put into man,'' he said.

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