BRITAIN: Differences between a cell signalling protein in humans and animals may explain the unexpectedly severe reaction in six young men given a new drug in a clinical trial in Britain, an expert said yesterday.
The previously healthy men were the first humans to receive the drug, designed to treat leukaemia and chronic inflammation disorders. Shortly after they were given the treatment last week, they suffered massive inflammation and excruciating pain.
Two are still critically ill, one is on organ support, and the other three are recovering.
Doctors are baffled about what went wrong in the trial of the antibody drug TGN1412, made by the privately-owned German company TeGenero AG, which had previously been tested in laboratories and on rabbits and monkeys.
TGN1412 belongs to a class of drugs known as monoclonal antibodies, which specifically bind to target molecules. TGN1412 targets an immune system protein called CD28.
Dr David Glover, a drug industry consultant with extensive experience of antibody treatments, said the protein the drug targets may not be the same in all species.