Table 1.
Safety of MGD019 in Cynomolgus Monkeys
| Group | M/F | Treatment | Dose Level (mg/kg) | Spleen |
|||
|---|---|---|---|---|---|---|---|
| Weight (%)a |
Pathologyb |
||||||
| Day 25, M/F | Day 93, M/F | Day 25, n/N | Day 93, n/N | ||||
| 1 | 5/5 | D5W | – | – | – | 0/6 | 0/4 |
| 2 | 5/5 | MGD019 | 10 | ↑14/↑42 | ↓9/↓10 | 0/6 | 0/4 |
| 3 | 5/5 | MGD019 | 40 | ↑57/↑61 | ↓4 /↑48 | 2/6 | 0/4 |
| 4 | 5/5 | MGD019 | 100 | ↑41/↑88 | ↑50 /↑28 | 5/6 | 0/4 |
D5W, 5% dextrose for injection; F, female; M, male.
a
Mean absolute spleen weight percentage increase (↑) or decrease (↓) from control values at days 25 and 93 necropsy; 3 animals per sex per group at day 25 and 2 per sex per group at day 93.
b
Incidence of minimal generalized splenic lymphoid hyperplasia at days 25 and 93 necropsy: number of animals with finding (n)/number of animals examined (N). Hyperplasia was characterized by the increased numbers of lymphocytes affecting all compartments of the lymphoid tissues, although follicles tended to be normal size.