FOR IMMEDIATE RELEASE

Contact: Shelley Aylesworth-Spink
Kingston General Hospital
613-548-2358
E-mail: ayleswos@KGH.KARI.NET

ATLANTA, April 30, 2000 - Interim results of a study presented today at the 95th Annual American Urological Association Meeting suggest that use of pentosan polysulfate sodium (Elmiron®) at up to three times standard dosing causes a significant improvement in symptoms of interstitial cystitis (IC), a painful and potentially debilitating bladder disease, with no serious adverse events. Further, patients experienced improvement in IC symptoms as early as four weeks after initiating treatment.

"These results are very encouraging for IC patients," said lead study investigator J. Curtis Nickel, M.D., of Queens University in Kingston, Ontario. "At the current recommended dose (300mg/day), it may take some IC sufferers three to six months of treatment to experience relief from symptoms. Our interim results suggest that administering higher doses of Elmiron may provide an important new approach to increasing the rate and extent of symptom of relief."

Interstitial cystitis (IC) is a chronic, progressive and frequently painful bladder condition, the cause of which is unknown. IC symptoms include urinary urgency (day and night), frequency and pain in the bladder and pelvic area. These symptoms may create substantial psychological and social problems. In addition, pain and sleep loss associated with IC can lead to depression.

Elmiron is the only FDA-approved oral medication for treating IC symptoms. Other treatments include invasive procedures that instill medication directly into the bladder. The current recommended dose of Elmiron is 300 mg/day, taken as one 100 mg capsule, three times daily.

Study Design
Patients were randomized to 100, 200, or 300 mg, three times daily. Response was measured by the IC Symptom Index (ICSI), on which 0 = no symptoms and 20 = symptoms almost always, and the Patients Overall Rating of Improvement of Symptoms (PORIS), on which patients with a score of 50 to 100 percent were considered responders. Measurements were obtained at baseline, 4, 8, 12, 16, 24 and 32 weeks of treatment. All patients had baseline and follow-up ICSI scores or week four PORIS scores.

Study Results
Interim results represent response data from patients in all three arms of the study. Data from individual arms will be analyzed separately upon completion of the study. At data cut off (blinded interim analysis), 275 patients enrolled, 137 continued and 76 discontinued.

Improvement in IC symptom scores was observed as early as four weeks. Specifically, mean ICSI scores improved from 13.0 (+/- 3.4) at baseline to 11.3 (+/- 4.1) at week four, decreasing even further to 10.8 (+/-4.7) at week 12 (p < 0.001 vs. baseline). After 12 weeks, the percent of patients with moderately severe symptom scores (10-16) fell by 42% and the percent of patients with mild to moderate scores (0-9) nearly tripled. The percent of patients who were considered responders doubled (18.7% to 39.3%) by week 12 (trend p < 0.001). No drug-related serious adverse events were reported. Common side effects were diarrhea (18.2%), headache (12.4%), nausea (10.9%), pain (10.9%) and alopecia (3.3%).

"We were pleased to find that no serious adverse events were reported, even at the highest dose administered (900mg/day)," said Nickel. "The final results of this study could have important implications for IC patients who may not respond sufficiently to the current recommended dose."

Pentosan polysulfate sodium structurally and chemically resembles the glycosaminoglycans, or "GAG layer," which lines the bladder. Although the exact mechanism of action for the drug is unknown, it is believed to strengthen the bladder's protective layer and act as a buffer, preventing irritating fluids from reaching the urinary tract lining.

Currently, the American Foundation for Urologic Disease is sponsoring a national educational campaign dedicated to raising awareness about IC. The campaign, entitled, "On Course for Better Health," features a Web site http://www.oncourseforbetterhealth.com, and toll-free number, 877-ON-COURSE, for more information.

This study is sponsored by ALZA Corporation.