FOR IMMEDIATE RELEASE: May 31, 2001

A New IC Clinical Trial Begins
with SI-7201 (Sodium Hyaluronate)

SEIKAGAKU Corporation is conducting a double-blind, placebo-controlled multicenter clinical study evaluating the safety and effectiveness of a sodium hyaluronate solution (SI-7201) when compared to placebo for the treatment of interstitial cystitis (IC).

The purpose of this study is to investigate the safety and effectiveness of 50mL of Sodium Hyaluronate (SH) solution (SI-7201), when infused into the bladder through a catheter, to treat the symptoms of IC. Sodium Hyaluronate is not approved in the United States for the treatment of IC, and is therefore considered investigational for this study. However, based on previous human use of Sodium Hyaluronate, there are indications it may be helpful in relieving IC symptoms.

SI-7201 (0.4% SH) is similar to Bioniche's product Cystistat (0.08% SH), which is approved for sale in Canada. Results obtained in a pre-clinical study, using SI-7201 in the rabbit model, comparing the concentrations of SH at 0.1, 0.2 and 0.4% suggest that SH is most effective and shows the greatest improvement at a concentration of 0.4%.

Following an initial screening visit, patients who meet criteria for study participation will be treated with SI-7201 via intra-vesicular instillation weekly for five weeks, followed by two bi-weekly instillations at weeks 6 and 8. They will then receive two more instillations at 4 week intervals (week 12 & 16) for a total of nine treatments over a 16-week period. Patients will return for safety and efficacy evaluations at week 20, 24 and 28.

The study population will consist of patients 18 years of age or older, who meet eligibility criteria. (IC will be diagnosed by cystoscopy and hydrodistention of the bladder under anesthesia).

SEIKAGAKU CORPORATION is a research based pharmaceutical company manufacturing drugs, medical devices, diagnostic products and reagents, and fine chemicals. Their Sodium Hyaluronate (SH) solution SUPARTZÔ, for the treatment of osteoarthritis of the knee, has recently been approved by FDA. This product has a higher concentration (1%) of SH and is given as an intra-articular injection.

Sponsor: Seikagaku Corporation
Protocol: SI-7201-01

Site Investigators:

Forrest, John B. M.D.
Urologic Specialists of Oklahoma, Inc.
1919 South Wheeling, Suite 700
Tulsa, OK 74104 USA
Phone: 1 918-878-8431