A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)

KEY

Inclusion Criteria:

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

- Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the
arterial phase on CT scanning)

- ECOG performance status 0, 1 or 2

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

- Platelet count ≥50,000 plts/mm3

- WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3

- Hemoglobin ≥10 g/dL

- Adequate liver function

KEY Exclusion Criteria:

- Received sorafenib as previous treatment for HCC for more than 14 days

- History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis
requiring systemic therapy for > 4 weeks)

- Prior treatment with JX-594

- 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

- Significant bleeding event within the last 12 months.