MHRA says no flaws found in TGN1412 clinical trial

The UK Medicines and Healthcare products Regulation Agency (MHRA) has released its interim report into the clinical trials of TGN1412. The trial led to six people being hospitalised last month after they experienced life threatening reactions to the drug.

The MHRA has found no evidence to suggest that there was a problem with the product developed by German pharmaceutical company TeGenero AG. It does not appear to have been contaminated, nor to have contained anything other than the correct ingredients. The MHRA said the trial had also been run according to the agreed protocol, and the correct dose of the product was given to the patients.

"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 that was not seen in pre-clinical tests in animals at much higher doses,' said MHRA chief executive, Professor Kent Woods.

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

The Association of the British Pharmaceutical Industry (ABPI) said it was committed to the safety of volunteers undergoing clinical trials and that it was vital that appropriate lessons are drawn from the recent event.

It welcomed the measures laid out by MHRA and, with the Bio Industry Association (BIA), is setting up an expert working group to provide industry input to the process.