CHRONIC ORAL TOXICITY STUDIES OF BOWMAN/BIRK INHIBITOR

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The Chemoprevention Branch of the Division of Cancer Prevention and Control at the National Cancer Institute directs a program to identify and develop drugs for human use that will prevent, delay, or reverse th progression of cellular dysplasia (e.g. intraepithelial neoplasia) to invasive cancer. Part of the drug research and development process involves preclinical toxicology studies. These studies are performed under Good Laboratory Practices according to guidance documents published by the Food and Drug Administration and are used to support Investigational New Drug applications and eventually New Drug Applications to the FDA for the marketing approval of cancer chemopreventive agents. The contractor shall conduct a 6-month oral toxicity study in mice and a 12-month oral toxicity study in dogs of the soy-derived compound Bowman- Birke Inhibitor. Endpoints shall include clinical and anatomic pathology with particular attention to the pancreas.