Exisulind Significantly Inhibits Tumor Growth With Minimal Side Effects

The results of a clinical study demonstrating thatexisulind (Aptosyn) slows tumor growth in men with advanced prostate cancer waspublished in the September 2001 issue of The Journal of Urology. The study isthe first to show the significant effect of this new class of drugs that maystabilize progressive, recurrent disease in patients with advanced prostatecancer. Previous studies in mice showed that exisulind inhibited the growth ofprostate cancer by 80% to 90%.

"These results suggest that exisulind may delay disease progression inmen with recurrent prostate cancer," said Dr. Erik Goluboff, assistantprofessor of urology at Columbia University College of Physicians and Surgeons,director of urology at The Allen Pavilion of New York-Presbyterian Hospital, andthe principal investigator of the trial. "This will subsequently prolongthe time period between postsurgical PSA rise and the need for androgendeprivation therapies."

PSA Levels Stabilized

For 12 months, the trial followed 96 prostate cancer patients who already hadtheir prostate glands removed. All had rising prostate-specific antigen (PSA)levels indicating recurrent disease. Half received exisulind, and half weregiven a placebo. The researchers measured the drug’s ability to slow or haltdisease progression by following patient’s PSA levels.

Imaging tests were performed before and after the study, which was funded byCell Pathways Inc, developer of the drug. All the men were classified into riskgroups with no statistical difference in age, race, and weight. The study showeda significant decrease in the rate at which PSA levels rose in patients givenexisulind compared with placebo. However, Dr. Goluboff cautioned that moreresearch needs to be conducted to determine the long-term effects in thesepatients and in other groups of patients with prostate cancer.