by Playfuls Staff |
6th April 2006
The Medicines and Healthcare products Regulatory Agency (MHRA) says it has not found any evidence to suggest any problem with the manufacturing of the experimental drug TGN1412, which caused six healthy volunteers to become dangerously ill. [more]
The product appears not to have been contaminated, stated the MHRA. In its interim report, it went on to say that the drug did not contain anything other than the correct ingredients.
The MHRA found nothing wrong in the way the trial was run which may have contributed to the adverse reactions experienced by the volunteers. According to the agency, the trial was run according to the agreed protocol and the correct dose of the product was 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.”
