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Six clinical trial patients admitted to critical care
Six patients involved in a Phase 1 clinical trial of a drug being developed for leukaemia, rheumatoid arthritis and mutliple sclerosis were admitted to critical care this week.
The Medicines and Healthcare products Regulatory Agency has suspended the trial, and says it has been assured that no one else has been given the product.
Eight healthy male volunteers aged 18–40 years were involved in the trial of TGN 1412, being developed by TeGenero AG, six of whom took the drug. The two patients who were given a placebo were unaffected. The patients were admitted to critical care at Northwick Park Hospital, London, from an independent medical research unit operated at the hospital by Parexel, a US company which provides clinical trial services. As The Journal went to press, the patients were in a serious condition and being monitored closely.
The MHRA will be sending inspectors to the unit to start investigations and will be working with North West London Strategic Health Authority, the Department of Health and the Metropolitan Police.
MHRA chief executive officer Kent Woods said: “Our immediate priority has been to ensure than no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken.”
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©The Pharmaceutical Journal
Citation: The Pharmaceutical Journal