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On-line clinical studies – LPS challenge testing

22 December 2006

As reported in the previous news article, another example of studies that require integration of bioanalytical and clinical pharmacology research units is given below.

During the last 24 months several LPS challenge projects have been conducted in our Clinical Pharmacology Research Unit in combination with our Bioanalysis and Drug Metabolism department. The purpose of such (ex-vivo/in-vitro and in-vivo) experiments is to measure the activity of immunosuppressants. The level of measured cytokines gives an indication on the inhibitory activity of the immunosuppressive drug and can be seen as a biomarker for the anti-inflammatory efficacy of the compound.

As the success of an in vitro/ex-vivo LPS challenge depends on the viability of the blood cells, the experiments have to be performed shortly after collection of the samples. Uniquely, Xendo’s Clinical Pharmacology Research Unit and the laboratory for Biochemistry and Immunology are located in the same building. This enables the execution of Phase I studies with existing or new immunosuppressive drugs, in which the LPS challenge experiments can be started immediately after blood collection. Furthermore, Xendo offers the analysis of cytokines in the resulting samples.

Currently, Xendo is also preparing for an in-vivo LPS-challenge test, to be conducted in the intensive care unit in the University Medical Center Groningen.