UK media claims TGN1412 trial was "reckless"

An investigative report for the UK's Dispatches television program has contradicted the claim by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which both sanctioned and investigated the ill-fated Northwick Park Hospital drug trial for German drugmaker TeGenero's TGN1412 monoclodal antibody (Marketletters passim).

Among the issues raised by the investigation, which was carried out by accessing data under the UK's Freedom of Information Act, it emerged that the drug candidate was administered to human trial volunteers 15 times more quickly than it had for animal tests.

Terry Hamblin, a monoclodal antibody expert at Southampton University, who has worked with the drug, told the UK's Sunday Times newspaper that: "when you give an antibody, the quicker you put it in, the more likely you are to get an infusion reaction." Prof Hamblin added: "to quickly infuse it over three to six minutes in six individuals I think is [...] reckless."