On March 13 six volunteers received TeGenero's TGN1412 drug and two a placebo in a phase 1, first-in-man trial, run by Parexel--a contract research organisation. Within hours of receiving the test drug, all six men were admitted to intensive care with a severe inflammatory reaction and multi-organ failure. Two remain critically ill.
The Medicines and Healthcare products Regulatory Agency (MHRA), who authorised the trial, told The Lancet that the trial protocol specifies that TGN1412 should be given at 2-hour intervals. However, whether this was followed is unclear. Thomas Hanke, TeGenero's Chief Scientific Officer, told The Lancet that the protocol states that the order and timing of drug administration was at the discretion of the principal investigator from Parexel. The MHRA and TeGenero denied The Lancet's request to see the protocol stating that it is "commercially sensitive."
The Lancet comments: "Although most first-in-man trials are not associated with such dreadful events, the fact that they have occurred should lead to maximum transparency to reaffirm trust in clinical trials and their regulation. Commercial confidentiality should not obstruct independent scrutiny of the TGN1412 protocol and trial conduct."
In an accompanying Comment published online today (Friday March 24, 2006) Colin Self and Stephen Thompson from the University of Newcastle upon Tyne, UK, highlight a potential problem with the use of monoclonal antibodies, such as TGN1412.
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