Drugs firm facing criminal charges as trial leaves two fighting for life

Staff at the pharmaceutical firm TeGenero, makers of the drug known as TGN1412, could face charges of violating drug research laws and causing bodily harm.

A spokesman in Wuerzburg, where the company is based, said: "We can confirm that a preliminary criminal investigation is underway."

It also emerged that Germany's drugs testing watchdog, the Paul Erhlich Institute, only granted permission for TeGenero to test TGN1412 in the country on 17 February after "preliminary concerns" were addressed.

But the institute refused to give details of these concerns.

Permission to test the drug in the UK was granted on 27 January.

It is unclear why human guinea pigs were picked in Britain, where they are paid around 2,000, when in Germany such healthy volunteers would have received 500.

Yesterday, doctors said four of the men being treated in Northwick Park Hospital in London had regained consciousness.

The other two remain in a critical condition under sedation but have shown early signs of responding to treatment, Dr Ganesh Suntharalingam said.

"Some of them have made noticeable progress in response to our treatment and we have been able to reduce the amount of organ support required," he said. "There are also some very early signs of response to treatment in the most critically ill patients, but I must stress their condition remains very serious and complex and it would not be sensible to comment on prognosis."

The men were healthy volunteers taking part in the first human trials of the drug in a private unit on the hospital site. TGN1412 had previously been tested on mice, rabbits and moneys before human trials began.

The monkeys were given doses 160 times stronger than the human volunteers without becoming sick.

It is understood that they did exhibit some reaction to the drug, although it is unclear what form that took.

A spokeswoman for TeGenero said: "The patients are most important at the moment. I cannot say why the testing was done in London and not Germany."

Thomas Hanke, TeGenero's chef scientific officer, insisted the drug "had been developed in accordance with all legal and clinical regulations".

Parexel, the US firm which was running the trials for TeGenero, described the men's illness as an "unfortunate and extraordinary" event.

TeGenero has abandoned plans for further testing of its immune system "super-drug", which was developed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.

The medical team in London has been consulting with experts from around the world about how to best treat the men.

The family of one victim, a bar manager from London, has appointed Alexander Harris Solicitors to deal with their case.

The man's girlfriend, Myfanwy Marshall, said he had been left looking "like the Elephant Man" after taking the drug.

William Wilson, the father of Ryan Wilson, 21 - the other man who remains in a critical condition - has travelled from Scotland to London to be with his son.

Yesterday, one of two men who took a placebo pill as part of the trial spoke of his lucky escape.

Nick Whybrew, 29, from Finsbury Park, north London, said: "I am just very, very lucky."