Drug Effective Against Polyps
HORSHAM, Pa. (Reuters) - Biotechnology firm Cell Pathways Inc. on Monday said patients treated with an experimental drug showed a substantial improvement in reducing precancerous colon polyps, but the company cautioned it may be years before the medicine is available for that use.
Cell Pathways' chief scientific officer, Dr. Rifat Pamukcu, told Reuters the polyp study adds supporting data to the validity of exisulind, a drug now in trial for lung cancer treatment.
Exisulind is being tested in Phase III trials -- typcally the last stage before a company applies for regulatory approval -- to treat lung cancer in combination with standard therapy, he said.
Using three different measures of efficacy, a 200-milligram dose of exisulind showed statistically significant reductions in polyps, compared with those taking a placebo, the company said.
Polyps are growths or tumors protruding from the mucous lining of an organ, and can eventually lead to cancer. Adenomatous polyps, which the company addressed in the trial, originate in glands.
The average polyp size in patients taking the drug was reduced by 35 percent, while patients on a placebo demonstrated a 5 percent increase in polyp size. The trial included 114 patients.
However, patients taking a 100-milligram dose of the drug showed virtually no difference from those taking the placebo, the company said.
Horsham, Pennsylvania-based Cell Pathways said it would need years and testing in more patients to advance the drug through its pipeline for the polyp indication.
``While these results are scientifically promising, registration-directed trials in the sporadic adenomatous polyp indication would require the enrollment of a thousand or more patients and take many years to conduct,'' Pamukcu said in a statement.
The company said experts estimate that 50 percent to 60 percent of colon polyps are precancerous adenomatous polyps. The rest are hyperplastic, or considered to be benign.
Pamukcu said a large-scale trial using the drug just to fight precancerous polyps would be too expensive, but the company would consider a partnership with another firm to conduct large tests of the drug against polyps or for other indications.