- Europäische Union Innovative Medicines Initiative (IMI)
The main impact of the MARCAR project will be to establish, for the first time, proof of concept that early biomarkers can reliably and robustly predict later cancer development. Validation of the biomarkers identified in the initial experiments will be a key stage in the project as early biomarkers of carcinogenicity would be immensely valuable in preclinical development of new drug compounds.
Current methods used in drug development result in a large number of compounds not reaching the market due to the late discovery of potential cancerous effects in laboratory studies. These compounds are not cancerous because they alter the genetic material/genes of the cell directly, i.e. genotoxic, as drugs that exhibit such characteristics are eliminated from consideration early in their development. They are the result of perturbation in other metabolic processes stimulated by the presence of the drugs such as increased cell division. Drugs that induce such cancers are called non-genotoxic carcinogens (NGC). The aim of the MARCAR project is to identify early biological indicators ("biomarkers") that can be used to predict the effects of NGC. At present, due to a lack of validated short-term assays, such cancer causing drugs are only identified following long-term experiments. The liver is the major target organ for such drug-induced tumours and the MARCAR project aims to advance our understanding of the availability of early markers of this carcinogenic risk and the design of more predictive short-term assessment tools. This will, in effect, reduce or eliminate the requirement for costly long-term biological testing and allow drugs to be developed with more confidence of success.