The Medicines and Healthcare products Regulatory Agency (MHRA) says that in the experimental drug TGN1412, has not been found anything other than correct ingredients and the product seems to not have been contaminated. But still, the health of the six volunteers of the drug trial is still in danger.
The MHRA has found nothing wrong in the protocol of the trial, also the correct doses were given to the volunteers.
MHRA Chief Executive Officer, 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.”
The MHRA has found nothing wrong in the protocol of the trial, also the correct doses were given to the volunteers.
MHRA Chief Executive Officer, 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.”