Dr. Jürgen Funk is awarded for his publication entitled "Histopathological findings after treatment with different oxidosqualene (OSC) inhibitors in hamsters and dogs" (1). In his work, Dr. Funk has brought together the results of repeat dose toxicity studies with oxidosqualene cyclase inhibitors, known as cholesterol-lowering agents, performed in hamsters and dogs. His paper is the first study describing the toxicity of OSC inhibitors after subchronic treatment in these species. Dr. Funk documents, that the spectrum of histopathologic lesions is the same in both species used and similar to what has been described for compounds of this pharmacological class. The adverse effects are precisely described and well documented. The results are appropriately discussed and lead to the conclusion that all adverse effects can be considered to be due to an exaggeration of the desired biochemical mechanism of action at high dose levels. Finally, the consequences of the adverse effects in humans are adequately considered.

This publication describes in an exemplary way the role of toxicologic pathology in pharmaceutical development. It is of particular interest, as the hamster represents a species which is only exceptionally used in this field of research and development.

Reference:

1. Funk J, Landes C (2005) Histopathological findings after treatment with different oxidosqualene cyclase (OSC) inhibitors in hamsters and dogs. Exp Toxic Pathol 57: 29-38

Copenhagen, September 30, 2005

* sponsored by Novartis Pharma AG