A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Recurrent Hepatocellular Carcinoma Not Amenable to Resection or Transplant

Inclusion Criteria:

- Age 18 years or older, males and females.

- Histologically or cytologically confirmed, or clinically diagnosed based on currently
accepted standards, cancer metastatic to the liver or HCC that is not amenable at the
time of enrollment to resection, transplant or other potentially curative therapy.

- The Target Lesion must be determined to be amenable to percutaneous injection by the
treating physician.

- The Target Lesion must have measurable disease, defined as a unidimensionally
measurable lesion ≥ 1.0 cm in longest diameter by helical CT.

- Performance status of Karnofsky scale 60%-100% or ECOG performance scale 0-2.

- Life expectancy ≥ 12 weeks.

- Hematopoietic Function: WBC ≥ 2,500/mm3; ANC ≥ 1000/mm3; Hemoglobin ≥ 8 g/dL;
Platelet count ≥ 50,000/mm3; Coagulation: INR ≤ 1.3.

- AST and ALT < 5 times ULN; ALP < 5 times ULN; Bilirubin ≤ 1.5 times ULN; Creatinine ≤
1.5 times ULN and eGFR ≥ 50.

- Thyroid Function: Total T3 or free T3, total T4 or free T4 and THS ≤ CTCAE Grade 2
abnormality.

- Renal Function: Adequate renal function in the opinion of the Investigator with no
clinically significant renal impairment or uncontrolled renal disease.

- Cardiovascular Function: Adequate cardiovascular function in the opinion of the
Investigator with no clinically significant uncontrolled cardiovascular disease.

- Respiratory Function: Adequate respiratory function in the opinion of the
Investigator with no clinically significant uncontrolled respiratory disease.

- Immunological Function: Adequate immune system function in the opinion of the
Investigator with no known immunodeficiency disease.

- Informed Consent: Signed by the subject prior to screening.

Exclusion Criteria:

- Primary HCC amenable to resection, transplant or other potentially curative therapy.

- Surgery: Subjects who have received hepatic surgery, ablation or chemoembolization
within 4 weeks of PV-10 administration.

- Radiation Therapy: Hepatic radiation within 4 weeks of PV-10 administration.

- Chemotherapy: Chemotherapy within 4 weeks of PV-10 administration (6 weeks for
nitrosoureas or mitomycin C). Subjects with HCC who have been on a stable dose of
sorafenib for at least 4 weeks will be candidates for enrollment in Expansion Cohort
2.

- Investigational Agents: Investigational agents within 4 weeks (or 5 half-lives) of
PV-10 administration.

- Phototoxic or Photosensitizing Agents: Concomitant agents posing a clinically
significant risk of photosensitivity reaction within 5 half-lives of PV-10
administration.

- Concurrent or Intercurrent Illness: Impaired wound healing due to diabetes;
Significant concurrent or intercurrent illness, psychiatric disorders or alcohol or
chemical dependence that would compromise Subject safety or compliance or interfere
with interpretation of the study; Uncontrolled thyroid disease (subclinical or
ongoing), goiter, partial thyroidectomy, previous radioiodine or surgically treated
Graves' hyperthyroidism or cystic fibrosis; Presence of clinically significant acute
or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal,
pulmonary, immunological (with the exception of the presence of hepatitis B virus
(HBV), viral hepatitis, or cirrhosis), endocrine, or central nervous system
disorders; Current encephalopathy or current treatment for encephalopathy; A
documented variceal hemorrhage within 4 months of screening; History of human
immunodeficiency virus or acquired immune deficiency syndrome; The clinical presence
of ascites.

- Pregnancy: Female subjects who are pregnant, lactating or have positive serum β HCG
pregnancy test taken within 7 days of PV-10 administration; Fertile subjects who are
not using effective contraception (e.g., oral contraceptives, intrauterine devices,
double barrier methods such as condoms and diaphragms, abstinence or equivalent
measures).