Market Opportunity for Treatment of Radiation Cystitis
Urigen estimates that the incidence of radiation cystitis in the United States is more than 34,000 cases per year. Although the symptoms of radiation cystitis are similar to those of interstitial cystitis, they can be differentiated based on medical history. In fact, clinical studies of products in development for interstitial cystitis typically exclude patients suffering from radiation cystitis. Currently, there are no approved treatments of these symptoms that are caused by pelvic irradiation.
Pelvic irradiation, both external beam and brachytherapy, represents one of the cornerstones of cancer therapy for a variety of local cancers including: prostate, ovarian, cervical, bladder, and colorectal cancers. Radiation cystitis, or pelvic pain and/or urgency of bladder origin secondary to pelvic irradiation, is a well-recognized side effect of pelvic irradiation.
Radiation cystitis is observed in 6-15% of patients receiving pelvic radiotherapy. For prostate cancer this rate is higher and ranges from 25-30%, or about 1 out of 3-4 men treated. The acute symptoms of radiation cystitis may be so painful as to disrupt the radiation treatment regimen. In most cases, acute symptoms are reversible several weeks after cessation of therapy. However there is a subset of patients that develop chronic radiation cystitis in which these symptoms remain indefinitely, possibly due to irreversible damage and/or improper healing of the bladder wall. The average time from the beginning of radiation therapy to chronic symptoms can be several months to several years.
Clinical Trial Status
Clinical experience with URG101 has demonstrated benefit in interstitial cystitis patients with a similar constellation of symptoms to Radiation Cystitis. Based on these observations, Urigen has expanded its IND to include the evaluation of URG101 in a Phase II multi-center, randomized, double-blind, placebo-controlled crossover to open-label study to evaluate the safety and efficacy of URG101 in patients exhibiting symptoms of pelvic pain of bladder origin secondary to pelvic irradiation.
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