Clinical Features of Bladder Cancer

Non-muscle-invasive bladder cancer (NMIBC) is the most common form of bladder cancer, comprising roughly 75% of all newly diagnosed bladder cancer in the United States and includes carcinoma in situ (CIS), Ta and T1 lesions. Together Ta and T1 lesions are termed papillary tumors. NMIBC is focus of clinical study with our lead product candidate, inodiftagene vixteplasmid (formerly BC-819).


Non-muscle-invasive bladder cancer subtypes have a low metastatic potential. The objective of treatment of patients with NMIBC is to prevent recurrence and progression to more invasive disease. They are resected and treated with adjuvant intravesical therapy. Inodiftagene is an experimental intravesical therapy. Muscle-invasive bladder cancers that are diagnosed de novo or originate from the progression of NMIBC signify a greater risk of metastatic disease and are treated with complete bladder resection. Prevention of progression, and of the need for bladder removal, is the key therapeutic goal. 

Diagnosis and NMIBC treatment

  • Diagnosed by cystoscopy
  • Papillary tumors are surgically removed by trans-urethral resection (TUR); CIS cannot be removed surgically and is          left to be treated with medical therapy
  • Resected/biopsied lesions are then classified pathologically and treated according to their staging
  • After TUR, Bacille Calmette Guerin (BCG, attenuated live tuberculosis bacteria) is administered into the bladder                (intravesically)
  • In patients for whom BCG is no longer indicated, limited treatment options are available outside of radical resection       of the bladder, a life-changing procedure

Inodiftagene is being developed for the treatment of patients diagnosed with NMIBC. Inodiftagene is being tested in two settings: in patients who have been treated with BCG and for whom a single course of treatment has failed; and in patients who have been treated with BCG and for whom two courses of treatment have failed. Disease in the latter population is termed BCG-unresponsive, and standard approaches to therapy for this group is bladder resection. The intravesical approach is well suited for inodiftagene treatment, with instillation into the bladder allowing direct contact of the drug to cancer cells at high concentrations without systemic exposure.