Table 1.
Clinical signs and associated clinical severity scores used in all studies.
Table 2.
Median time to onset of clinical signs (in hours) and 95% confidence interval for each clinical sign across toxin dose groups, and median time to death (in hours) and range.
Fig 1.
Kaplan-Meier survival curves for BoNT/A intoxicated monkeys treated with BAT.
Monkeys were intoxicated with 4x LD50/kg dose of BoNT/A and treated intravenously with either dose of BAT (1x or 0.1x scaled human dose) or placebo after 4 hours post-intoxication before the onset of clinical signs. The proportion of animals that survive to 14 days post-toxin exposure in is shown for each group.
Table 3.
Summary of mortality and median time to death data-PEP study.
Table 4.
Incidence of clinical signs in BAT and placebo group-PEP study.
Table 5.
Median time to onset of clinical signs in placebo group-PEP study.
Table 6.
Median time to onset of clinical signs in monkeys-Therapeutic Study 1.
Table 7.
Survival and median time to death for monkeys treated with BAT at the onset of systemic disease-Therapeutic Study 1.
Table 8.
Estimated median time to onset of clinical signs for monkeys intoxicated with 1.7xLD50/kg of BONT/A-Therapeutic Study 2.
Fig 2.
Kaplan-Meier survival curves for BoNT/A intoxicated monkeys treated with BAT.
Groups of monkeys (n = 30/group) were intoxicated with 1.7x LD50/kg dose of BoNT/A and monitored hourly for the onset of clinical signs. Monkeys were individually administered with either BAT at 1x scaled human dose or placebo intravenously after the onset of clinical signs indicative of botulism (Study 2) and monitored for survival to 21 days post-toxin exposure.
Table 9.
Survival and median time to death for monkeys treated with BAT at the onset of systemic disease-Therapeutic Study 2.
Table 10.
Duration of clinical signs in monkeys treated with BAT-Therapeutic Study 2.
Fig 3.
Clinical severity scores were calculated for each individual animal at a given observation time point.
Monkeys were intoxicated with 1.7x LD50/kg dose of BoNT/A and treated intravenously with either BAT at 1x scaled human dose or placebo after the onset of clinical signs indicative of botulism. Clinical signs were monitored during the course of infection and the clinical severity scores were calculated for each individual animal at given observation time point after intoxication. The designation for the clinical score for each sign is shown in Table 1. The data reflects the average sum of severity scores over time for both BAT (1x scaled human dose) and the placebo group.