The purpose of this project is to procure the toxicologic evaluation, in animals, of oral iron chelating compounds, for use in the safe and effective removal of iron deposits in patients with iron overload conditions (e.g., Cooley's anemia, an orphan disease). A clinical evaluation is not desired at this time. The contractor shall conduct toxicologic and related studies of selected iron chelating compounds, in rats, dogs, and other animals as directed by the Project Officer, and shall provide resulting toxicologic information to the NIDDK for use in preparing submissions to the Food and Drug Administration for approval of eventual clinical studies. The drugs under development are considered to be orphan drugs.
