Table 5 Synthesis of main results concerning the assessment of clinical and genomic safety of subjects treated with IDN 5933
Safety threat | Assessment | Marker | Results | Interpretation |
|---|---|---|---|---|
Clinical adverse effects | Diary of adverse effects / clinical records at T0 and T1 | Treatment associated symptoms / Unexpected symptoms | 1 death unrelated to treatment No symptoms associated to treatment | No occurrence of clinical symptoms associated to the treatment |
Liver injury | Laboratory testing at T0 and T1 | ALT – AST – γGT | No new subjects reported pathological exams at T1 | No liver injury associated to the treatment |
Genomic instability | Laboratory testing at T0 and T1 | Cytokinesis Block Micronucleus assay | No increase of mean MN frequency in subjects treated with IDN 5933 [MR = 0.98; 0.84–1.16] | No increase of genomic instability associated to the treatment |
DNA damage | Laboratory testing at T0 and T1 | Comet assay | No increase of mean TI% damage in subjects treated with IDN 5933 [MR = 0.96; 0.64–1.40] | No increase of DNA damage associate to the treatment |
Modulation of genes involved in liver carcinogenesis | Laboratory testing at T0 and T1 | c-myb – p53 – ctnnb1 expression level [mRNA level] | No association with treatment | No altered expression of liver cancer genes associated to the treatment |