TABLE 1.
Study overview
| Study | Study design | Treatment regimen and/or dose | Total no. of animals | Mean LD50 challenge spore dose (SD) |
|---|---|---|---|---|
| NZW rabbits | ||||
| PEP | Postexposure, dose-ranging, and levofloxacin combination study in challenged animals; dose received 9 h after anthrax exposure | 0 mg/kg i.v. | 9 | 268.6 (47.5) |
| 4 mg/kg i.v. | 9 | 287.8 (69.5) | ||
| 4 mg/kg i.v. + levofloxacin at 50 mg/kg/day p.o. for 5 days | 9 | 262.3 (40.8) | ||
| 8 mg/kg i.m. | 9 | 270.4 (38.4) | ||
| 8 mg/kg i.m. + levofloxacin at 50 mg/kg/day p.o. for 5 days | 9 | 252.6 (41.7) | ||
| levo at 50 mg/kg/day p.o. for 5 days | 12 | 297.3 (55.2) | ||
| Cynomolgus macaques | ||||
| Preexposure | Prophylaxis; i.m. dose received within 24, 48, and 72 h preexposure | 0 mg/kg (24, 48, 72 h) | 10 | 217.8 (65.2) |
| 16 mg/kg (24 h) | 14 | 237.3 (96.1) | ||
| 16 mg/kg (48 h) | 14 | 209.3 (61.6) | ||
| 16 mg/kg (72 h) | 15 | 220.2 (86.7) | ||
| PEP 1 | Postexposure; i.v./i.m. dose-ranging study in challenged animals; dose received 24 h postexposure | 0 mg/kg i.v. | 6 | 324.2 (70.6) |
| 2 mg/kg i.v. | 9 | 315.6 (83.4) | ||
| 8 mg/kg i.v. | 9 | 288.7 (49.1) | ||
| 4 mg/kg i.m. | 8 | 366.0 (113.56) | ||
| 8 mg/kg i.m. | 9 | 289.0 (51.8) | ||
| PEP 2 | Postexposure; i.m. dose-ranging study at increasing times postexposure (18–36 h) | 0 mg/kg (18 h) | 6 | 395.7 (166.8) |
| 8 mg/kg (18 h) | 6 | 461.7 (151.6) | ||
| 16 mg/kg (18 h) | 6 | 422.8 (157.8) | ||
| 8 mg/kg (24 h) | 6 | 385.5 (133.4) | ||
| 16 mg/kg (24 h) | 6 | 305.2 (130.2) | ||
| 8 mg/kg (36 h) | 6 | 409.5 (131.1) | ||
| 16 mg/kg (36 h) | 6 | 431.8 (215.4) | ||
| PEP 3 | Postexposure; i.m. obiltoxaximab efficacy at increasing times postexposure (24–48 h) | 0 mg/kg (24 h) | 10 | 200.7 (45.9) |
| 16 mg/kg (24 h) | 14 | 209.0 (56.8) | ||
| 16 mg/kg (36 h) | 14 | 197.6 (92.4) | ||
| 16 mg/kg (48 h) | 16 | 208.9 (67.8) |