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| |  Aptosyn Inhibits Rise In PSA Levels Following Radical Prostatectomy HORSHAM, PA -- November 17, 1999 -- Cell Pathways, Inc. announced positive results from an analysis of the completed clinical trial of its lead drug Aptosyn(TM) (exisulind) in prostate cancer patients.
Before entry into the study, each of these men had exhibited rising prostate specific antigen (PSA) levels despite having had his prostate surgically removed. In such a patient, a rise in PSA suggests a recurrence of the cancer and an increased risk of developing advanced disease. After one year, the patients receiving Aptosyn experienced a statistically significant inhibition of the rise in average PSA levels compared to those on placebo. "We are very excited about these findings," said Dr. Rifat Pamukcu, chief scientific officer of the company. "They indicate that, at the end of one year of therapy, Aptosyn significantly slowed the rise of PSA levels in men at risk of recurrent prostate cancer. These results confirm the earlier positive six-month interim analysis of these patients. There is much to be learned from this study, and we are now engaged in more in-depth analyses of the data." He continued, "to our knowledge, the Food and Drug Administration (FDA) has yet to approve a treatment for prostate cancer solely on the basis of a drug effect on PSA levels. The medical community, nonetheless, widely regards PSA as a surrogate marker indicative of the status of the disease, particularly in a patient who has had his prostate surgically removed. "We plan to discuss with the FDA the overall clinical development plan with the ultimate goal of obtaining approval for Aptosyn for the prevention and treatment of prostate cancer." Ninety-two of 96 enrolled patients were evaluable in this randomized double blind, placebo-controlled, multi-center trial. Of the 92 evaluable patients, 47 received placebo and 45 received Aptosyn. Results from the 92 evaluable patients showed that the rise in average PSA levels in the Aptosyn-treated group was significantly lower than that seen in the placebo-treated group. The company also performed a subgroup analysis in which patients were prospectively classified as high-, intermediate- and low-risk for developing metastatic disease. The one-year treatment data showed statistically significant differences in the rise in average PSA levels between Aptosyn and placebo patients in the high-risk group and a strong trend toward significance in the intermediate risk group. The safety profile of Aptosyn was similar to those observed in previous clinical trials, with two patients discontinuing therapy due to indigestion. "The fact that we obtained statistically significant results, even in this high-risk subgroup of patients, is especially compelling. Current management is that many of these men will eventually be treated by chemical castration if their PSA continues to rise. These findings will be submitted for presentation at scientific meetings and to peer-reviewed journals over the coming months. "Given that we are confident in our belief that Aptosyn is having activity in prostate cancer, we are now conducting four open-label studies of Aptosyn across several stages of prostate cancer, and expect to have results of those studies during the coming year," said Dr. Pamukcu. Aptosyn is Cell Pathways' lead drug candidate from a new class of compounds called selective apoptotic anti-neoplastic drugs (SAANDs). These compounds inhibit a cyclic GMP phosphodiesterase and selectively induce apoptosis (programmed cell death) in abnormally growing precancerous and cancerous cells but not in normal cells. Because SAANDs do not affect normal cells, they do not produce the serious side effects normally associated with traditional chemotherapeutic agents. They also do not inhibit cyclooxygenase (COX I or COX II) and have not exhibited the gastric and renal toxicities reported to be associated with non-steroidal anti-inflammatory drugs (NSAIDs), including the COX II inhibitors. A New Drug Application for the use of Aptosyn for the prevention and treatment of precancerous colonic polyps in patients with Familial Polyposis (FAP), which was submitted on August 25, 1999, is currently under review by the FDA. A one-year trial of Aptosyn in children with FAP is nearing full enrollment. Additional clinical trials with Aptosyn are underway that target breast and lung cancers, Barrett's Esophagus and sporadic colonic polyps. Cell Pathways recently announced a collaboration with Rhone Poulenc Rorer to study the combination of Aptosyn and Taxotere(R) in prostate, lung, breast and pancreatic cancers. CP-461, Cell Pathways' second generation SAAND, is a compound with higher apoptotic potency and is targeted for cancer indications. CP-461 recently achieved high blood levels and good tolerability in a Phase Ia trial and is currently in a Phase Ib trial in cancer patients.
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