Implications for the authorisation of clinical trials following the experience of TGN1412 in London

In a commentary in the May edition of ‘Nature Biotechnology’, scientists of the Paul-Ehrlich-Institut (PEI) in Langen near Frankfurt am Main, discuss the possible implications of the unexpected serious adverse effects during the TGN1412 trial in the UK. This is intended to launch a wide-ranging debate within the scientific community. The scientists in Langen also describe the fundamental problems of assessing monoclonal antibodies on the basis of products which have already obtained a marketing authorisation. Finally, the scientists discuss the question under what conditions medicinal products should be tested in healthy individuals or in patients who may benefit from the treatment. The PEI has been the competent authority for clinical trials with monoclonal antibodies (mab) in Germany since August 2004.

"Under no circumstances should we make the mistake of rating all monoclonal antibodies as 'high-risk' products”, says Prof. Löwer, the President of the institute. “Rather, we recommend taking due account of three definition criteria for classifying monoclonal antibodies as 'lower' or 'higher risk' products before entering the clinical phase". Classifying a product as “high-risk” mab would call for extended preclinical development before the start of a clinical trial. Moreover, in such cases a trial phase would have to be introduced, in which individual clinical trial subjects are treated one after another with adequate time intervals.

The Paul-Ehrlich-Institut's commentary is designed to encourage a debate between representatives of industry, researchers, and the authorities responsible for the authorisation of the trials. This will help to find ways to develop and refine the enormous therapeutic potential of monoclonal antibodies while minimising the risk to individuals participating in a clinical trial.

Interested journalists may request an advance copy of the publication from the Press Unit of the Paul-Ehrlich-Institut. The embargo set by the publishers must be observed under all circumstances.

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