TGN1412 AE during ph.I study: MHRA final report

Press release
Date: 25 May 2006
Time: 12:47
Subject: Clinical trial final report
Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189


Following on from an interim report published by the Medicines and Healthcare products Regulatory Agency (MHRA) on 5/4/06 into the adverse incidents which occurred on 13/3/06 during the clinical trial of TGN1412 a final report has today been issued on the matter (see below).

In addition to the various inspections carried out by MHRA inspectors and the German Regulatory Authorities, further tests have been conducted on the drug product. The product testing focused on the batch used in the original toxicology studies as well as the batch used in the trial. Although there were some ‘good clinical practice’ discrepancies identified (see below), the conclusions remain the same as reported in April 2006, that an unexpected biological effect is the most likely cause of the severe reactions in the six trial volunteers.

“This is a very complex scientific issue, which will be reviewed by the independent expert scientific group appointed by the Secretary of State for Health. We are satisfied that the adverse incidents which occurred were not as a result of any errors made in the manufacture of TGN1412, its formulation, dilution or administration to trial participants” said Professor Kent Woods, MHRA Chief Executive.


Notes to Editor

Full details of the Expert working group are available from the Department of Health (020 7210 5375)
Full report below
Download documents:
Investigations into adverse incidents during clinical trials of TGN1412 Press release: Final report on TGN1412 clinical trial