New tests sought for designer drugs

April 6th 2006

Trials of new "magic bullet" drugs are to face additional scrutiny following the near-catastrophic reactions which left six volunteers in London close to death, it was announced yesterday.

Regulators said no evidence could be found of mistakes being made in the process which led to the disastrous trial at Northwick Park Hospital, London.

Instead they pointed to the novelty of the new drug, TGN1412, that was being tested.

The drug is a monoclonal antibody, a genetically engineered class of drugs which has been hailed for years as a "magic bullet" because of its ability to achieve precise targeting.

The latest theory is that TGN1412 was designed to tweak the immune system - but researchers failed to anticipate the chain reaction it would set off in human patients.

Under a new procedure all human trials of monoclonal antibodies in Britain will now have to gain a further level of evidence. This will be sought by the Medicines and Healthcare Products Regulatory Agency to check for the possibility of unexpected reactions.

The British government is also gathering a group of international experts to discuss improved ways of screening monoclonal antibodies.

The MHRA said its investigations had been exhaustive and included the seizure of documents and samples from the hospital.

MHRA Chief Executive Professor Kent Woods said: "There are still further tests planned and until these are complete we cannot be firm about our conclusions. However, if these findings were to be confirmed, it would indicate that this product showed a pharmacological effect in man which was not seen in pre-clinical tests in animals at much higher doses.

"The Secretary of State for Health has therefore agreed to establish a group of leading international experts in the field to examine the issue further. The Group will need to review the evidence from the TGN1412 case and consider what necessary changes to clinical trials may be required."

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