Bladder cancer is the 4th most frequent solid tumor cancer in men, and 7th in women, with a prevalence of 840,000 patients in Europe and 530,000 patients in the U.S., and over 180,000 new cases in Europe and the U.S. diagnosed annually.
The initial treatment of this type of cancer is surgical removal of the tumors, followed by a series of chemotherapy instillation treatments. After instillation, drug concentration is immediately reduced and washed out due to continuous urine creation. Thereby, the cancerous tissue is not optimally exposed to the drug allowing tumor re-seeding and migration. Around 35% of NMIBC tumors recur within one year. Due to the low mortality and lifelong treatments and monitoring, related to the high recurrence rate, bladder cancer is one of the most expensive cancers to treat on a per patient basis. The cost per patient from diagnosis to death can reach $120,000, translating to an estimated $3.8 billion annual spend in the U.S.
UroGen is poised to potentially to address these drawbacks by developing VesiGel, a novel sustained release formulation of the chemotherapy agent Mitomycin C (MMC).
The scientific concept demonstrating that longer chemotherapy exposure time increases treatment efficacy is well established and was demonstrated in several pre-clinical and clinical trials for bladder cancer.
We are developing VesiGel, our novel sustained-release formulation of high-dose MMC, for the treatment of low-grade NMIBC. VesiGel is currently being evaluated in a Phase 2 trial being conducted in Europe and Israel. Results to date demonstrate the showed safety, feasibility as well as efficacy of VesiGel as a potential chemoablation agent for the treatment of low grade bladder cancer patients. To date, over 80% of patients treated with VesiGel in the study have achieved a complete response, eliminating the need for surgical intervention. Durability of response is still been evaluated, but preliminary results showed that over 80% of the patients who achieved a complete response had a durable response at 12 months follow-up without any additional therapy during this time.