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Dundee Playing Central Role in €12 Million European Union Biomarker Project

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The University of Dundee is to play a key role in a €12million research project aiming to find early indicators of certain types of cancer and increase the effectiveness of the development of new drugs.

The MARCAR project may also help reduce the need for the use of animal testing in some areas of bioscience research.

MARCAR is a collaboration between 12 partners involving academia and the pharmaceutical industry and is funded by the European Union Innovative Medicines Initiative. The University of Dundee is managing the project and Dundee-based biotech firm CXR Biosciences is one of the partners.

“The development of new drugs is a very costly process, partly because of the large number of drugs which never make it to market due to the discovery of cancerous effects during drug development,” said Professor Roland Wolf, Director of the Biomedical Research Institute at the University of Dundee and Scientific Co-ordinator of the MARCAR project.

“Predictions regarding safety of drug compounds can be imprecise and sometimes incorrect. If we could make better predictions at an early stage of drug development it would save a lot of time and money and make the whole process more efficient.

“To achieve that we need to identify early biological indicators, known as `biomarkers’, that can be used to predict the effects of drugs and reliably and robustly predict later cancer development. This would be immensely valuable in preclinical development of new drug compounds.

“It would also be of benefit to pharmaceutical companies through improved internal selection of potential drugs, fewer delays and adverse effects during late-phase drug development, and improved pre-clinical carcinogenicity safety assessment prior to clinical trials. Translation of early cancer biomarkers into the clinic would also improve safety for patients participating in clinical trials.”

The project will focus on a group of drugs known as non-genotoxic carcinogens (NGCs). These are drugs which when tested are shown to promote biochemical processes which lead to cancer.

At present such potential cancer causing compounds only tend to be identified following prolonged biological trials. If successful, the MARCAR will reduce the requirement for long-term biological testing. Dr. Tom Shepherd, Chief Executive of CXR Biosciences Ltd in Dundee said, “This research project will address a critical and costly

bottleneck in the safety assessment of drugs and chemicals. Unraveling the complexities involved necessitates the combined skills and experience of both industry and academia across Europe and if successful, could bring significant benefits.”

The identification of biomarkers will be achieved using a variety of techniques including epigenetic profiling, clinical imaging and bioinformatics.

Dr Colin Henderson, Staff Scientist in the Biomedical Research Institute, added “This is a very important EU project, which will be of significant importance in determining the carcinogenic risk to humans from a range of chemicals.”

One of the drivers behind finding better strategies for conducting biological studies is the `3 R’ issue – the reduction, refinement and replacement of experimental animal use. The MARCAR project aims to tackle this issue by not only developing a method for conducting reliable short-term studies which will reduce the need for long-term biological testing but by exploring another strategy which involves non-invasive imaging techniques including PET and MRI scanning.

As both techniques are non-invasive, long term studies can be carried out on the same animal over weeks or months. They also have the potential to detect precancerous lesions and tumours at a much earlier time point without the need to sacrifice the animals for analysis. This means much smaller numbers of animals can be used as multiple analyses can be carried out using the same animals.

“This would potentially markedly reduce the numbers of animals needed for this kind of research and provide a much more reliable prediction of the rates of toxicity of drugs in development in man ,” said Professor Wolf.