Clinical development plan: Sulindac sulfone

• Publisher: John Wiley and Sons
• Year: 1996
• Tongue: English
• Weight: 772 KB
• Volume: 63
• Category: Article
• ISSN: 0730-2312
• DOI: 10.1002/jcb.240630717

✦ Synopsis

The NCI, Chemoprevention Branch is developing sulindac sulfone as a chemopreventive agent under a Clinical Trial Agreement with Cell Pathways, Inc. (CPI; Denver, CO). Sulindac sulfone is a metabolite of the FDA-approved nonsteroidal antiinflammatory drug (NSAID) sulindac, also currently under development by the Chemoprevention Branch [ 11. Sulin- dac, the parent compound, has been shown to be effective in preventing carcinogen-induced rat colon and mouse bladder cancer [2,3] and in causing the regressionof colorectal adenomas in cases of familial adenomatous polyposis (FAP) [4-61 or Gardner's syndrome [7], a phenotypic variant of FAP. FAP is a hereditary disease characterized by the Occurrence of hundreds to thousands of adenomatous polyps in the colon. Adenomatous polyps are considered to be intermediates in the pathologic progression from normal colorectal epithelia to carcinomas in both sporadic and familial settings. Colorectal adenomas, or subsets of them defined on the basis of their size or histopathology, are considered validated and predic-