Under the agreement, Xceleron will provide accelerator mass spectrometry (AMS) services to assist Servier in taking candidate drugs into humans much earlier than conventional Phase 1 studies. Xceleron is contracted to supply AMS analysis on a “fee for service” basis for 12 months with the option to continue the agreement on a rolling annual basis, said Jeremy Hague, European Business Development Manager of Xceleron, in an interview.
As many as one in three drugs fail in Phase I clinical testing despite extensive pre-clinical screening of potential clinical candidates with a wide variety of in silico, in vitro, ex-vivo and animal models. A high proportion of these failures can be attributed to sub-optimal pharmacokinetics (PK) leading to potential efficacy or safety issues in humans. There is general recognition by the pharma industry that more clinical information needs to be gathered earlier than currently practiced. The AMS technology permits Phase I/mass balance studies to be combined, absolute bioavailability studies to be conducted with less animal safety testing, early human metabolite profiling and human microdosing (Phase 0 studies) as an aid in candidate selection. All these approaches allow earlier entry into humans of new drug compounds and hence assist in reducing attrition rates later down the clinical development path, Xceleron said.
Xceleron said its agreement with Servier is the first of its kind whereby a pharma company is altering its traditional discovery/development processes to accommodate early human studies as part of the drug candidate selection processes.
Xceleron was a spin-out company from the Jack Birch Unit of Environmental Carcinogenesis, Department of Biology, University of York and was founded in early 1997 by Xceleron’s current CEO Professor Colin Garner.
Servier is a privately-owned company, established in 1954 by its founder and current Chairman, Jacques Servier. Its main therapeutic products used to treat diabetes, cardiovascular disease, neuropsychiatric disorders, cancer, and bone and joint diseases.
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