Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Exclusion Criteria

• •1. Patient has evidence of muscle-invasive disease (i.e., T2 or higher)
• •2. In the Investigator's opinion, patient is not able to hold instillation for at least 1 hour.
• •3. In the Investigator's opinion, patient cannot tolerate intravesical administration or intravesical surgical manipulation.
• •4. Patient has received radiation therapy of pelvis within 12 months before the first study drug treatment.
• •5. Patient requires perioperative intravesical chemotherapy.
• •6. Patient has a history of malignancy of the upper urinary tract.
• •7. Patient has bone marrow impairment as evidenced by:
• •* Hemoglobin \<9.0 g/dL
• •* Absolute neutrophil count (ANC) \<1.5×109/L
• •* Platelet count \<120×109/L.
• •8. Patient has renal impairment, as evidenced by:
• •* Serum creatinine \>2× the upper limit of normal (ULN), and/or
• •* Calculated creatinine clearance \<40 mL/min.
• •9. Patient has liver function abnormality, as evidenced by:
• •* Total bilirubin \>1.5×ULN, or
• •* Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \>2.5×ULN.
• •10. Patient has a bleeding disorder, as evidenced by an international normalized ratio (INR) \>1.5×ULN.
• •11. Patient is known to be positive for human immunodeficiency virus (HIV) or has active hepatitis B or C infection.
• •12. Patient has a clinically significant active infection at the time of the first study drug treatment.
• •13. Patient has any medical or psychiatric condition that, in the Investigator's opinion, might impair the patient's well-being or preclude adherence to the protocol or completing the study as per protocol.
• •14. Patient has suspected hypersensitivity to imidazoquinoline compounds, poloxamer 407, hydroxy propyl betacyclodextrin, or lactic acid.
• •15. If female, patient is pregnant or breast feeding.
• •16. Patient participated in any other protocol involving administration of an investigational agent within 3 months before Day 0.