Xceleron has announced that following signature of a Master Services Agreement with Sanofi-Aventis Deutschland GmbH, a number of studies are underway to assess the human metabolism of compounds in early clinical development.
According to Professor Colin Garner, Xceleron CEO, “Xceleron is delighted to be working with Sanofi-Aventis to optimise their radiolabelled clinical studies. Increasingly leading pharmaceutical companies are adopting Xceleron’s new drug development strategies to maximise data on compounds in the exploratory clinical development phase. This powerful new knowledge enables our partners to make much more informed decisions about the future clinical development of each new drug.”
Dr. G. Ulrich Kuerzel, Deputy Head, GMPK Frankfurt and Head of Metabolism/In Vitro Systems for Sanofi-Aventis Deutschland GmbH at Frankfurt observed that “initial data we are receiving from these studies confirm our interest in using Xceleron’s ultra-sensitive analytical technology – we are gaining important information that has not been available to us previously”.
Xceleron’s approach enables human drug-metabolite profiling to be performed in the early stages of clinical development; ideally as part of an enhanced Phase I study. This type of analysis allows drug developers to detect and measure ultra-low levels of both known and previously unknown metabolites producing data that isn’t available using other analytical techniques.
The discovery of human-specific metabolites at the later stages of clinical development is therefore avoided with potentially significant financial savings. Early human profiling also helps identify the most suitable species for use in long term toxicology and pharmacology studies.