A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib

Inclusion Criteria:

- Histologic or cytologic confirmation of primary hepatocellular carcinoma (HCC)

- Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib
treatment at least 14 days prior to randomization due to either intolerance or
radiographic progression

- ECOG performance status 0, 1 or 2

- Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites

Exclusion Criteria:

- Received systemic therapy other than sorafenib within 28 days of randomization

- Prior treatment with JX-594

- Platelet count < 50,000 PLT/ mm3

- Total white blood cell count < 2,000 cells/mm3

- Hematocrit < 30% and/or Hemoglobin < 10 g/dL

- Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or
medication

- Severe or unstable cardiac disease

- Viable CNS malignancy associated with clinical symptoms

- Pregnant or nursing an infant