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News

London drug trial volunteer faces aggressive cancer

Monday, 7 August 2006
Cosmos Online

SYDNEY, 7 August 2006 - One of the eight men who took part in the notorious drug trial in London shows early signs of an aggressive form of cancer, doctors have reported.

David Oakley, 35, of London, shows "definite early signs" of lymph cancer, doctors told the Mail on Sunday newspaper. They said he will undergo further tests to determine appropriate treatments. If he does develop the aggressive cancer and survives it, he also faces risk of multiple sclerosis, lupus, rheumatoid arthritis and other illnesses.

On 13 March this year, six healthy volunteers participated in a phase I trial of a new experimental drug known as TGN1412, for which they would earn £2,000. The drug was an anti-inflammatory compound to treat conditions such as rheumatoid arthritis and leukaemia.

Immediately after the drug was administered, all six participants experienced a type of 'cytokine release syndrome', a condition in which their own immune system attacks organs of the body.

Nav Modi, 24, the first of the men to be administered the drug, began to feel unbearable pain in his head and back. Soon, the other five men who had also received an active dose began to moan and cry out for painkillers. Two of the men received a harmless placebo.

"I felt like my head swelling up like an elephant's – I thought my eyeballs were going to pop out," Modi later told BBC News.

Another volunteer, Ryan Wilson, 20, faced the possibility of losing all of his toes and three of his fingers, BBC News reported. Describing the experience as "hellish", he suffered heart, liver and kidney failure, pneumonia, and septicaemia.

Oakley said he was first told he might develop lymph cancer about two months ago when blood tests revealed "cells that shouldn't be there" – an indication of the early stages of cancer, according to BBC News. "It's very frightening," he said. "I'm trying not to be too down about the thought of having chemotherapy, or that I might die."

He had taken part in the study so he could earn enough to help cover the costs of his wedding to his then finacee, reported to the newspaper. "Katrina and I had planned to start trying for children six months after getting married, but we can't do that now. Everything is on hold."

All men were healthy when they agreed to test a new monoclonal antibody drug for German company TeGenero AG at a Northwick Park Hospital in northwest London, operated by Parexel International, a U.S. drug research company.

TGN1412 was a new class of monoclonal antibody. Although it has been known to affect certain types of cells in the immune system, its adverse effect on humans had not been predicted by pre-clinical testing.

According to an interim report published by Britain's Medicines and Healthcare Products Regulatory Agency (MHRA), concluded that an unexpected biological effect is the most likely cause of the severe reactions.

"This is a very complex scientific issue, which will be reviewed by the independent expert scientific group appointed by [Britain's] Secretary of State for Health," said Kent Woods, chief executive of the MHRA. "We are satisfied that the adverse incidents which occurred were not as a result of any errors made in the manufacture of TGN1412, its formulation, dilution or administration to trial participants."

with Agençe France-Presse