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. 2017 May 5;9(5):742–755. doi: 10.1080/19420862.2017.1324376

Table 5.

In vivo studies for anti-DLL4 Fab’2 fragment.

Species Study Dose/s Group sex and size Findings
Sprague Dawley rat 8 week GLP toxicology 0 mg/kg (iv) 10M+10F/group and 5M+5F recovery/group and 6M+6F TK satellites/group Liver findings: Decreased severity compared with IgG, minimal changes observed at low doses (up to 10 mg/kg)
3 mg/kg (iv) Acceptable hematology profile
10 mg/kg (iv) Proliferative vascular neoplasms not observed
100 mg/kg (iv) New findings: Vascular proliferative/degenerative changes in the heart and lung potentially related to pulmonary hypertension
30 mg/kg (iv)
Cynomolgus monkey 8 week GLP toxicology with 12 week recovery 0 mg/kg (iv) 3M+3F/group and 2M+2F recovery/group and 2M+2F for telemetry on the control and high dose group Liver findings: Decreased severity compared with IgG
5 mg/kg (iv) Acceptable hematology profile
15 mg/kg (iv) New findings: Vascular proliferative/degenerative changes in the heart and lung potentially related to pulmonary hypertension
50 mg/kg (iv)