Inclusion Criteria

• Histologically-confirmed non muscle-invasive bladder cancer with CIS, high grade Ta or any grade T1 papillary disease or CIS plus papillary disease following adequate BCG treatment
• CIS, Ta or T1 disease is documented as unresponsive to (i.e., not intolerant to) adequate BCG therapy
  • Adequate BCG therapy is defined as at least 7 instillations of BCG over 2 cycles (1 induction course of at least 5 doses over 6 weeks + 1 maintenance cycle of at least 2 doses over 6 weeks, or up to 2 induction courses of BCG with or without interferon)
• Male or non-pregnant, non-lactating female
• Females of childbearing potential and all males with partners of childbearing age only if they agree to use highly effective contraceptive techniques or abstinence during the 24-month study period
• Has had bladder biopsy mapping the location of the tumors and quantifying the affected area of the bladder within 8 weeks before study drug administration
• Has life expectancy of at least 4 years
• Has adequate organ function, as defined by
  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN)
  • Total serum bilirubin ≤1.5 x ULN (CTCAE grade ≤1)
  • Serum creatinine ≤2.0 x ULN
    • A serum creatinine >1 x ULN must also have creatinine clearance ≥50 mL/min
  • Hemoglobin ≥8.0 g/dL
    • Subjects receiving therapeutic erythropoietin preparations (i.e., epoetin alfa, darbepoetin alfa) are eligible to enroll
  • Absolute neutrophil count ≥1500 x 109/L
  • Platelets ≥75,000 x 109/L
• Ability to understand and sign an Independent Ethics Committee or Institutional Review Board approved informed consent document

Exclusion Criteria

• Is pregnant or breastfeeding
• Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging 
• Evidence of higher stage disease by pelvic imaging within the past 2 years
• Has hydronephrosis, except for where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T1 by more than 2 years) and diagnostic evaluation at screening shows no evidence of tumor
• Has had any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug
• Current severe urinary tract infection 
• History of recurrent severe bacterial cystitis
• Has an active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the Investigator, would predispose to the development of complications from the administration of intravesical therapy and/or general anesthesia
• History of other primary malignancy (other than squamous or basal cell skin cancers) that will require concomitant cancer therapy during the 24 months of the study
• A QTc interval of >450 msec for males or > 470 msec for females at the screening ECG
• Cannot, in the opinion of the Investigator, tolerate intravesical administration or intravesical surgical manipulation