Six men hospitalised after drug trial

Six men are in intensive care after falling ill during trials of a new anti-inflammatory drug.

Eight healthy male volunteers participated in the trial of TGN 1412 - a drug manufactured by German company TeGenero AG to treat conditions such as leukaemia and chronic inflammatory conditions - at a facility in the grounds of Northwick Park Hospital, London.

However, on Monday, six men had to be admitted to intensive care after suffering a serious reaction to the drug. The two other volunteers, who had been given a placebo, were not affected. No one else, other than the six men, were given the drug.

Two of the men are in a critical condition, while the other four are described as being in a serious condition, but are showing signs of improvement. All the men, who have suffered multiple organ failures, remain in intensive care.

A police investigation into the drug trial has now been launched.

Myfawny Marshall, whose boyfriend is one of the men in a critical condition, told BBC News that the 28-year-old's face was so puffed after taking the drug that he resembled the Elephant Man. Ms Marshall told the BBC: "This is a drug that they have never tested on humans before so they don't know what they are dealing with."

The Medicines and Healthcare Products Regulatory Agency immediately suspended the trial of the drug after the men were taken ill. Chief Executive Professor Kent Woods said: "Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."

Paraxel, the company which was running the trial, said that it had followed guidelines and stressed that such reactions to drugs were extremely rare. Professor Herman Scholtz from Paraxel said: "When the adverse drug reaction occurred, the Paraxel clinical pharmacology medical team responded swiftly to stop the study procedures immediately."

TeGenero Chief Executive Dr Benedikte Hatz said: "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers."

The eight men are understood to have been paid £2,000 each to participate in the trial of the drug, which had already been tested on animals and in a laboratory.

(KMcA/GB)