Table 2.

Repeated dose toxicity test (GLP). [Evaluation for ① acute toxicity ② local irritability ③ toxicokinetics ④ central nervous system].

1. GLP

2. Test animal: Cynomolgus monkey

3. Test substance: pVAX-HSP65 DNA/human IL-12 DNA+ HVJ-E

4.Evaluation: ①acute toxicity(blood examination, etc.)

②local irritability test

③toxicokinetics(TK)

Human IL-12 in the blood of monkeys

④safety pharmacology study

central nervous system (CNS)

Repeated dose toxicity test of preclinical study using monkey is planned to investigate for clinical trial.