Study detailing safety and efficacy of exisulind in treating recurrent prostate cancer

HORSHAM, PA (August 9, 2001): Cell Pathways, Inc. (Nasdaq: CLPA) today announced publication of the detailed results of a double-blind, placebo-controlled clinical study of exisulind in the treatment of recurrent prostate cancer following radical prostatectomy in the September issue of The Journal of Urology. The results of the Phase II/III study, involving 96 patients at multiple centers throughout the United States, demonstrated that exisulind inhibited the rise in PSA (prostate specific antigen) levels in treated men overall and significantly prolonged PSA doubling time in high-risk patients compared with placebo. The study was supported by a grant from Cell Pathways, and the results were initially reported by the principal investigator at the 95th annual meeting of the American Urological Association in May 2000.

These results suggest that exisulind may delay disease progression in men with recurrent prostate cancer and thus prolong the time period between initial post-surgical PSA rise and the need for androgen deprivation therapies, said Erik T. Goluboff, MD, assistant professor of urology at Columbia University College of Physicians & Surgeons and director of urology at the Allen Pavilion of NewYork-Presbyterian Hospital, principal investigator of the study. Hormonal therapy produces high response rates in metastatic prostate cancer, but patients develop resistance over time. The side effects of hormonal treatment can significantly impact the patients quality of life. New treatment options that might delay the need for such side effect prone therapies could provide great benefit in the management of prostate cancer.

The primary efficacy measurement for the one-year, single-agent study was the difference in the change in PSA levels from baseline between the placebo-treated and exisulind-treated groups. The clinical effect of exisulind therapy was initially observed two to three months after commencing treatment, and continued throughout the st

Contact: Joan Kureczka
Kureczka/Martin Associates

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