A Phase I-IIa, Multicenter, Open-Label, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Patients With Non-Muscular-Invasive Bladder Cancer

Inclusion Criteria:

- Patients with initial presentation or recurrence of Stage Ta, T1 or Tis, any grade,
bladder cancer after transurethral resection of bladder tumor (TURBT).

- TURBT within 42 days prior to Day 1/Week 1

- Karnofsky Performance Status greater than or equal to 80%

- Life expectancy at least 3 years

- 18 years or older

- A negative pregnancy test (if female of child-bearing potential)

- Acceptable liver function within 7 days defined as: bilirubin less than or equal to
1.5 times upper limit of normal, and AST (SGOT), ALT (SGPT), and alkaline phosphatase
≤ 2.5 times upper limit of normal

- Acceptable renal function within 7 days defined as: serum creatinine less than or
equal to 1.5 times upper limit of normal, or calculated creatinine clearance greater
than or equal to 40 mL/min/1.73 m2

- Acceptable hematologic status within 7 days defined as: absolute neutrophil count
(ANC) greater than or equal to 2,500 cells/mm3, platelet count greater than or equal
to 150,000/mm3, and hemoglobin greater than or equal to 10.0 g/dL.

- Urinalysis showing no clinically significant abnormalities except those attributable
to bladder cancer.

- For men and women of child-producing potential, agreement to use an effective
contraceptive method during the treatment period of the study.

- Signed, written Institutional Review Board (IRB)-approved informed consent

Exclusion Criteria:

- History or previous diagnosis of bladder fibrosis

- Total bladder capacity estimated at cystoscopy to be less than 150 mL

- Urinary incontinence of a severity that would compromise the ability of the patient
to retain the study drug intravesical instillation for two hours.

- Severe irritative voiding symptoms such as urgency, frequency, or nocturia

- Known other malignant disease except squamous or basal cell skin cancer unless the
malignancy has been in complete remission off therapy for at least 5 years.

- Major surgery, other than TURBT and diagnostic surgery, within 28 days prior to Day
1/Week 1.

- Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract
infection.

- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy
within one (1) month prior to Day 1/Week 1 on study (two [2] months for nitrosureas
or MMC), unless given as standard treatment for bladder cancer and provided that
patient is free of all treatment-related toxicities as of Day 1/Week 1.

- Known infection with human immunodeficiency virus (HIV)

- Known active infection with hepatitis B or hepatitis C

- Serious disease (e.g., hydronephrosis, liver failure, or other conditions) that could
compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
(Halozyme).

- History of a hypersensitivity or idiosyncratic reaction to, or other contraindication
to, mitomycin.

- Known allergy to bee or vespid venom

- Known coagulation disorder or bleeding tendency

- Treatment with heparin or anticipation of heparin treatment during the treatment
period in this study.

- Unwillingness or inability to comply with procedures required in this protocol.