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05/04/2006
Drugs trial 'followed correct protocols'
An investigation into the drugs trial which left six men seriously ill in hospital has ruled that the trial followed the agreed protocol.
The Medicines and Healthcare Products Regulatory Agency report said that there was nothing in the way the trial was run which contributed to the adverse reactions suffered by the volunteers.
The report also found that there was no problem with the manufacturing of the drug TGN 1412, that it did not appear to have been contaminated and that the men all received the correct dose.
The conclusions were published in the MHRA's interim report. MHRA Chief Executive Professor Kent Woods said: "There are still further tests planned and until these are complete we cannot be firm about our conclusions. However, 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."
Professor Woods said that Health Secretary Patricia Hewitt had agreed to establish a group of international experts to examine the issue further.
The six men all fell ill after taking TGN 1412 - an anti-inflammatory designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis - during a trial at Northwick Park Hospital, London.
The men suffered multiple organ failure and two were left in a critical condition. However, five of the men have now been released from hospital, while the remaining patient is said to be making "steady progress".
The trial, which was being conducted by US firm Parexel on behalf of German drug manufacturers TeGenero, was immediately suspended when the men fell ill.
(KMcA/GB)
The Medicines and Healthcare Products Regulatory Agency report said that there was nothing in the way the trial was run which contributed to the adverse reactions suffered by the volunteers.
The report also found that there was no problem with the manufacturing of the drug TGN 1412, that it did not appear to have been contaminated and that the men all received the correct dose.
The conclusions were published in the MHRA's interim report. MHRA Chief Executive Professor Kent Woods said: "There are still further tests planned and until these are complete we cannot be firm about our conclusions. However, 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."
Professor Woods said that Health Secretary Patricia Hewitt had agreed to establish a group of international experts to examine the issue further.
The six men all fell ill after taking TGN 1412 - an anti-inflammatory designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis - during a trial at Northwick Park Hospital, London.
The men suffered multiple organ failure and two were left in a critical condition. However, five of the men have now been released from hospital, while the remaining patient is said to be making "steady progress".
The trial, which was being conducted by US firm Parexel on behalf of German drug manufacturers TeGenero, was immediately suspended when the men fell ill.
(KMcA/GB)
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