Since polyp formation rates in patients with FAP are variable, the original one-year Phase III study was prospectively designed to detect a statistical difference in polyp formation rates only in patients who historically formed between 10 and 40 new polyps per year. In 34 patients that fit the criteria, those treated with Aptosyn™ experienced a 53% reduction in the mean and median number of polyps formed versus placebo-treated patients. The patients tolerated the treatment with Aptosyn well.
Following the initial one-year study, patients in both the treatment and placebo arms that completed the Phase III trial have been offered Aptosyn™ therapy as part of a 12 month, open-label extension study. These patients receive 600 mg of Aptosyn™, total daily dose, and investigators count and remove all rectal polyps at six-month intervals. After six months of therapy in the extension trial, the crossover group (formerly placebo) showed a median polyp reduction of 50%. Patients who had been in the treatment arm showed an additional 50% reduction in polyp formation, or an overall 75% reduction after 18 months of therapy. The patients continue to tolerate treatment with Aptosyn™ well.
"Over 50% of my patients who participated in the original Phase II trial of Aptosyn™ have continued to take the drug for up to 57 months, and they no longer form clinically significant colon polyps," Dr. Burke commented.
"We are very encouraged by all of our results to date with Aptosyn™ as a potential new treatment for individuals with FAP, an indication for which it is currently under review by the Food and Drug Administration," commented Rifat Pamukcu, M.D., senior vice president of research and development and chief scientific officer of Cell Pathways. "In addition to these studies in adult FAP patients, we are currently conducting a study in children with FAP."
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Contact: Joan Kureczka, J. Kureczka Assoc.
JKureczka@aol.com
415-821-2413
Kureczka/Martin Associates
22-May-2000