Drug effect blamed in UK trial

Pharmaceutical watchdog reaffirms that an unexpected biological effect of TGN1412 probably caused reactions in six men

Stephen Pincock
May 24, 2006
An unexpected biological effect of the monoclonal antibody TGN1412 was the most likely cause of the severe reactions in six men participating in a clinical trial in March, Britain's drug watchdog reiterated Thursday (May 25).The final report from the Medicines and Healthcare products Regulatory Agency (MHRA) confirms the main findings from an interim report published in April. "We are satisfied that the adverse incidents which occurred were not as a result of any errors made in the manufacture of TGN1412, its formulation, dilution or administration to trial participants," the MHRA's chief executive, Kent Woods, said in a statement.The report does, however, note that the contract research company running the trial, Parexel, failed to meet good clinical practice guidelines in several areas -- for example, not putting in place a formal arrangement for 24-hour medical cover for patients. However, none of these lapses likely caused the serious adverse events seen...

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