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Therapeutic efficacy of equine botulism heptavalent antitoxin against all seven botulinum neurotoxins in symptomatic guinea pigs


Autoři: Douglas Barker aff001;  Karen T. Gillum aff002;  Nancy A. Niemuth aff002;  Shantha Kodihalli aff001
Působiště autorů: Research and Development, Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada aff001;  Battelle Biomedical Research Center, West Jefferson, Columbus, Ohio, United States of America aff002
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0222670

Souhrn

Botulism neurotoxins are highly toxic and are potential agents for bioterrorism. The development of effective therapy is essential to counter the possible use of these toxins in military and bioterrorism scenarios, and to provide treatment in cases of natural intoxication. Guinea pigs were intoxicated with a lethal dose of botulinum neurotoxin serotypes A, B, C, D, E, F or G, and at onset of the clinical disease intoxicated animals were treated with either BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)–(Equine)] or placebo. BAT product treatment significantly (p<0.0001) enhanced survival compared to placebo for all botulinum neurotoxin serotypes and arrested or mitigated the progression of clinical signs of botulism intoxication. These results demonstrated the therapeutic efficacy of BAT product in guinea pigs and provided supporting evidence of effectiveness for licensure of BAT product under FDA 21 CFR Part 601 (Subpart H Animal Rule) as a therapeutic for botulism intoxication to serotypes A, B, C, D, E, F or G in adults and pediatric patients.

Klíčová slova:

Biology and life sciences – Toxicology – Toxic agents – Toxins – Bacterial toxins – Botulinum toxin – Neurotoxins – Neurotoxicology – Antitoxins – Organisms – Eukaryota – Animals – Vertebrates – Amniotes – Mammals – Rodents – Guinea pigs – Medicine and health sciences – Pathology and laboratory medicine – Mental health and psychiatry – Substance-related disorders – Intoxication – Public and occupational health – Infectious diseases – Bacterial diseases – Botulism – Euthanasia – Research and analysis methods – Animal studies – Experimental organism systems – Animal models


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