Mouse models for pretesting of immunotherapeutic strategies for cancer patients.

There are two major reasons for using mouse models for preclinical testing of immunotherapetic strategies before proceeding to clinical trial. First, the requirements of regulatory authorities for toxicity testing and, second, the need of the investigator to convince himself/herself and the grant-giving bodies that proceeding with a clinical trial is scientifically justified. In both cases, the mouse model presents problems specific to a therapy depending on immune effector cells and their products. These are particularly evident in evaluating therapies for cancer patients, where analysis of cellular responses can often be better evaluated in in vitro studies with human peripheral blood leukocytes. However, where mouse models can show an effect on tumour growth, they can be extremely useful for evaluating the mechanisms underlying the effect, as we have found in evaluating tumour rejection of MUC1 expressing tumours. Moreover, strains carrying transgenes of human target antigens allow testing for auto-immunity.