A phase I clinical trial of TGN1412 was suspended in March after all six trial volunteers taking the drug candidate were hospitalized after suffering serious adverse events.
The regulator said that it has found no evidence to suggest that there was any problem with the manufacturing of the product that was given to the trial volunteers. According to the MHRA, the product appears not to have been contaminated, or to have contained anything other than the correct ingredients.
The regulator also said it has not found anything in the way the trial was run that contributed to the adverse reactions experienced by the volunteers – it was run according to the agreed protocol, and the correct dose of TGN1412 was given to the trial participants.
“There are still further tests planned and until these are complete we cannot be firm about our conclusions,” commented MHRA chief executive Professor Kent Woods. “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 preclinical 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.”
Commenting on the MHRA’s findings, TeGenero issued a statement thanking the agency for conducting the investigation. In this statement, the company said, “The preliminary findings of the investigation underline that we observed the highest standards in developing this drug and that these symptoms were both unexpected and unforeseeable. The information released today shows that there was no sign of risk from the pre-clinical tests of TGN1412.”
It continued, “The announcement of a new expert commission to supervise future trials of monoclonal antibodies challenges all of us in the biotechnology industry to think again about the safest way to develop new medicines in the future.”
In the latest update on the trial volunteers, the UK’s Northwick Park Hospital has confirmed that all six patients have been discharged from critical care and five have returned home. The other patient still receiving treatment in the hospital is said to be making “steady progress.”