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Cell Pathways Reports Extension Study Results Showing Ability Of FGN-1 To Prevent Formation Of Precancerous Colon Polyps

Investigational Drug Halts New Polyp Formation; Appears Well-Tolerated For Extended Use

HORSHAM, PA (May 20, 1998) -- Cell Pathways, Inc. today announced results from an open-label extension study of the company's lead investigational compound, FGN-1--(exisulind), in patients with Familial Adenomatous Polyposis (FAP; also known as Adenomatous Polyposis Coli, APC). Eighteen patients continuing on FGN-1 for as long as 18 months following the completion of a six month Phase I/II dose-ranging, safety and efficacy trial tolerated drug treatment well. The progressive increase in precancerous polyps that normally occurs in this patient population appeared to be arrested by the treatment. In addition, existing polyps in the FGN-1 treated patients appeared to decrease in size or remain stable over time.

The extension study results will be presented today at the American Gastroenterological Association meeting in New Orleans, Louisiana by clinical investigator, Rosalind van Stolk, M.D. of the Cleveland Clinic Foundation.

"FAP patients have historically experienced, on average, a significant increase in the number of precancerous polyps that develop in their rectum over a 12 month period," said Dr. van Stolk. "In contrast, we observed that new polyp formation halted in all patients receiving effective doses of FGN-1 for periods of 12 to 24 months, and in 16/18 patients, small polyps (6 mm or less) tended to regress in size while larger polyps remained stable."

"We are very encouraged by these results, which show a strong trend that supports FGN-1's ability to prevent the normal progression of disease in patients with FAP," said Rifat Pamukcu, M.D., chief scientific officer and senior vice president of research and development at Cell Pathways. "Left untreated, FAP patients invariably develop colon cancer." He noted that a randomized, placebo-controlled Phase III trial of FGN-1 i
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Contact: Joan Kureczka
JKureczka@aol.com
415-821-2413
Kureczka/Martin Associates
20-May-1998


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