Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients

Inclusion Criteria:

* Patient is 18 years of age or older.
* Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
* Patients diagnosed with Low Grade (LG) or High grade (HG) NMIBC.
* No active urinary tract infection as confirmed by urine culture.
* If the patient is a female of childbearing potential, she is using two acceptable \& effective methods of contraception, until 6 months post treatment
* A negative serum pregnancy test at screening for female patient with childbearing potential
* If the patient is a male he should use a condom during intercourse, for at least 48 hours post each instillation.
* If the patient is a male that has a partner that is a female of childbearing potential, he should be advised to use two acceptable \& effective methods of contraception until 6 months post treatment.

Exclusion Criteria:

* Tumor located in prostatic urethra (for male patient) or in the bladder diverticulum.
* Prior or required pelvic radiotherapy.
* Systemic chemotherapy within 1 year prior the screening.
* Pregnant or breastfeeding female patient.
* Treatment of bladder cancer with BCG within the last 12 months prior to screening visit . Exception: For patient that had BCG treatment within 6-12 months prior to screening visit and are not symptomatic, the patient may enroll at the investigator discretion.
* Treatment (full course) with intravesical chemotherapy within the 3 months, prior to screening visit.
* Contraindication to MMC treatment as per investigator determination, or known sensitivity to MMC or TC-3 ingredients.
* The patient has a known current urinary retention which requires intermittent catheterization to empty the bladder.
* The patient has a bleeding disorder or a screening platelet count \<100X109/L.
* The patient has screening hemoglobin \<10g/dL OR white blood cells \< 4000 mm3.
* GFR\<30
* Hepatic values exceeding 2 times the upper normal limit.
* The patient has a concurrent severe and/or uncontrolled medical condition (e.g., uncontrolled diabetes, compensated congestive heart failure \[NYHA III and over\], myocardial infarction within 6 months of screening visit, unstable or uncontrolled hypertension or an active uncontrolled infection) or psychiatric disease, which could compromise participation, compliance with scheduled visits, and/or completion of the study in the opinion of the investigator.
* The patient has a documented severe vesico-ureteral reflux or has an in-dwelling ureteral stent.
* The patient participated in an investigational interventional study within the past 90 days, prior to screening visit.