6.2 Schedule 
Each patient will receive a single administration of ACN53 via hepatic arterial catheter. 
6.3 Dose 
6.3.1 Dosages will be calculated based on functional units of ACN53 (TCED 50 units; see 
Appendices E and G). 
Dose Levels; 
Level 0; 
1.0 X 10 7 units 
Level 1: 
1.0 X10 8 units 
Level 2; 
1.0 X10 9 units 
Level 3: 
1.0 X 10 10 units 
Level 4: 
1.0 X 10 11 units 
Level 5: 
3.3 X 10 11 units 
Level 6: 
1.0 X 10 12 units 
Level 7; 
3.3 X 10 12 units 
Level 8: 
1.0 X 10^3 un i ts 
6.3.3 The first 3 patients enrolled in the study will receive ACN53 at Dose Level 1. If no 
dose-limiting toxicity (DLT) is observed after a period of at least 7 days of post- 
treatment monitoring (see Section 8.0), the next 3 patients will receive ACN53 at 
Dose Level 2, and so on. If DLT is observed, the appropriate dose escalation 
decision rule will be followed (see below). 
6.3.4 Dose Escalation 
The dose level will be escalated to the next level according to the following rules. 
DLT and MTD are defined in Section 8.2. 
# of Patients with DLT 
at Current Dose Level Dose Escalation Decision Rule 
0 out of 3 
1 out of 3 
2 out of 3 
Enter next 3 patients at the next dose level. 
Enter up to 3 additional patients at current 
dose level. If none or 1 out of 3 of the second 
group experiences DLT, then enter 3 patients 
at the next dose level. As soon as 2 of the 
second group experience DLT, then the MTD 
has been reached at the previous (lower) level 
and dose escalation will stop. 
Enter up to 3 additional patients at current 
dose level. If none experience DLT, then 
enter 3 patients at the next dose level. As 
soon as any patient of the second group 
experiences DLT, the MTD has been reached 
at the previous (lower) level and dose 
escalation will stop. 
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