57% of patients achieved full remission of new treatment for urethroid skin cancer with positive results in Phase 3

UroGen Pharma announced that UGN-101, a non-surgical treatment for low-grade upper urethra cancer (LG UTUC), achieved positive top-line results in critical Phase 3 clinical trials, with 57 percent of patients achieving complete remission (CR).
UTUC usually refers to cancerous skin cells in the urethra on the kidneys and urethra. UTUC is usually at high risk of local recurrence and may be transferred. UTUC currently accounts for 5-10% of urethroid skin cancer and has about 45,000 patients in the United States, about 14,500 of whom are low-grade diseases. There is currently no FDA-approved non-surgical treatment for UTUC, which still represents an unseeded medical need.
UGN-101 is a urethra skin gel developed by UroGen, an active ingredient called fissamycin. UGN-101 can be dripped into the patient's lesions through a standard intra-bladder catheter, and UroGen's special formula is liquid at room temperature, but condenses into a semi-solid state at room temperature. This property maintains the continuous release of the drug dripping at the lesions, allowing urinary tract tissue to be exposed to fissromycin for long periods of time, thus treating tumors using non-surgical methods. UGN-101 has been awarded fast-track eligibility by the FDA and the orphan drug qualification and breakthrough therapy for LG UTUC.
in this multi-center International 3 clinical trial, a total of 71 LG UTUC patients were treated with UGN-101, 45 percent of which were of the type that could not be surgically removed. The results showed that 57% of patients in the intended treatment group achieved complete remission when they were assessed for major diseases 4-6 weeks after the end of the course of treatment. It is worth noting that all patients who reached full remission did not have a recurrence of the cancer within the next 6 months.
"We are pleased to report that UGN-101's data on complete mitigation and efficacy continuity are consistent with the interim analysis conducted in May 2018. These results continue to demonstrate that UGN-101 has the potential to change the treatment model of UTUC, benefiting patients who previously could only undergo repeated endoscopic surgery or have their kidneys removed completely," said Dr. Mark P. Schoenberg, Chief Medical Officer of UroGen. We are very grateful to the patients and their families, as well as clinical researchers, for their participation in making this important study possible." (Bio Valley)