Carcinoma in Situ
MitoGel™, a novel sustained-release RTGel-based formulation of MMC, has the potential to become the first FDA-approved drug for the treatment of low-grade Upper Tract Urothelial Carcinoma and to serve as a first-line chemoablation agent, sparing patients from repeated tumor resection surgical procedures and potentially reducing the need for kidney and upper urothelial tract removal.
VesiGel™, a novel sustained-release RTGel-based formulation of high dose MMC, has the potential to replace TURBT and become the new first-line standard of care for low-grade NMIBC. VesiGel, a chemoablation agent, is administered locally using standard catheters in a physician’s office as a same-day treatment, in comparison with TURBT conducted under general anesthesia in a hospital setting.
Vesimune, an immune-modulation product candidate, could represent a valid alternative to the current standard of care for the BCG adjuvant, post TURBT treatment of high-grade NMIBC. Vesimune’s active ingredient is Imiquimod, an imidazoquinoline, synthetic immune modulator, which specifically targets TLR7, which is expressed in bladder cancer cells.
About UroGen Pharma
UroGen Pharma (“UroGen” or “the Company”) is a clinical-stage biopharmaceutical company focused on developing novel therapies designed to change the standard of care for urological pathologies with a focus on uro-oncology. The Company has an innovative and broad pipeline of product candidates that it believes can overcome the deficiencies of current treatment options for a variety of urological conditions with a focus on uro-oncology. The lead product candidates, MitoGel and VesiGel, are proprietary formulations of the chemotherapy drug Mitomycin C, or MMC, a generic drug which is currently used off-label for urothelial cancer treatment in a water-based formulation as an adjuvant, post-surgery, therapy. The Company’s clinical stage pipeline includes Vesimune, its proprietary immunotherapy product candidate for the treatment of high-grade non-muscle invasive bladder cancer. In addition, BotuGel is a proprietary novel RTGel-based formulation of BOTOX, a branded drug, that it believes can potentially serve as an effective treatment option for patients suffering from overactive bladder. UroGen has licensed the worldwide rights to BotuGel to Allergan Pharmaceuticals International Limited, or Allergan, a wholly owned subsidiary of Allergan plc, which plans to commence a Phase 2 clinical trial of BotuGel.