April 18, 2006

Drug trial victim may lose fingers and toes

LONDON (Agence de Presse Medicale) - A man who fell into a
coma in London last month during a clinical trial of TeGenero's
monoclonal antibody TGN1412 has said he may lose parts of his
fingers and toes, the UK's News of the World newspaper reported
on Sunday.

"I'm told it's like frostbite and my fingers will just fall
off," Ryan Wilson told the newspaper in an interview.

Photographs in the newspaper showed Wilson in bed at
Northwick Park Hospital, in northwest London, where the trial
took place, with his blackened feet and hands.

Wilson, 20, from London, was the most seriously ill of six
men whose heads and bodies swelled up following injections of
TGN1412 in March. He said he may well need to stay in hospital
for six more months as his condition is monitored.

"The doctors say they don't want to take my fingers off
because that's messier than if the body sorts itself out, " he
told the newspaper. "So if the fingers fall off they'll
actually heal better.

"They're waiting for pink flesh to move further up the
feet, but the tips of most of my toes are basically dead. So at
the very least I'll lose them."


Wilson was among the volunteers to have been given the
TGN1412, created by the German biotech group TeGenero, by the
contract research company Parexel.

Wilson said he took part in the trial, which paid 2,000,
to fund driving lessons and a holiday.

He suffered heart, liver and kidney failure, pneumonia,
septicaemia, and was ventilated on oxygen. Doctors then tried
to save him from dry gangrene.

"When I woke up in intensive care after almost three weeks
unconscious, I only realised how serious my injuries were when
I saw my hands and feet were black," he told the News of the

The other five volunteers have all been released from
hospital after suffering less severe symptoms.

TeGenero has said the men's reactions were "completely
unexpected" and did not reflect the results obtained from
earlier laboratory studies.

In an interim report on the case earlier this month, the
UK's Medicines and HealthCare Products Regulatory Agency (MHRA)
concluded that there was no evidence of problems with the
quality of the test drug and no contamination or dosage errors.

It found there were no obvious errors in the testing
procedure but said in future first-in-man trials of similar
drugs would not be authorized without expert advice.