{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T14:09:51Z","timestamp":1740146991692,"version":"3.37.3"},"reference-count":51,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,17]],"date-time":"2023-03-17T00:00:00Z","timestamp":1679011200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["HHSO100200500007C"],"award-info":[{"award-number":["HHSO100200500007C"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>To meet the requirements of the Animal Rule, the efficacy of monotherapy with ANTHRASIL<jats:sup>\u00ae<\/jats:sup> (Anthrax Immune Globulin Intravenous (Human)) for inhalational anthrax was evaluated in blinded studies using rabbit and nonhuman primate models. Animals in both studies were randomized to treatment groups exposed to ~ 200 LD<jats:sub>50<\/jats:sub> <jats:italic>Bacillus anthracis<\/jats:italic> (Ames strain) spores by the aerosol route to induce inhalational anthrax. Rabbits (N = 50\/group) were treated with either 15 U\/kg ANTHRASIL or a volume-matching dose of IGIV after disease onset as determined by the detection of bacterial toxin in the blood. At the end of the study, survival rates were 2% (1 of 48) in the IGIV control group, and 26% (13 of 50) in the ANTHRASIL-treated group (p = 0.0009). Similarly, ANTHRASIL was effective in cynomolgus monkeys (N = 16\/group) when administered therapeutically after the onset of toxemia, with 6% survival in the IGIV control and a dose-related increase in survival of 36%, 43%, and 70% with 7.5, 15 or 30 U\/kg doses of ANTHRASIL, respectively. These studies formed the basis for approval of ANTHRASIL by FDA under the Animal Rule.<\/jats:p>","DOI":"10.1371\/journal.pone.0283164","type":"journal-article","created":{"date-parts":[[2023,3,17]],"date-time":"2023-03-17T17:35:02Z","timestamp":1679074502000},"page":"e0283164","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy of ANTHRASIL (Anthrax Immune Globulin Intravenous (Human)) in rabbit and nonhuman primate models of inhalational anthrax: Data supporting approval under animal rule"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2997-2095","authenticated-orcid":true,"given":"Srinivas","family":"Kammanadiminti","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Comer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriel","family":"Meister","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Trevor","family":"Carnelley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Derek","family":"Toth","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1520-5952","authenticated-orcid":true,"given":"Shantha","family":"Kodihalli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,3,17]]},"reference":[{"issue":"10","key":"pone.0283164.ref001","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.3201\/eid0810.020353","article-title":"Investigation of bioterrorism-related anthrax, United States, 2001: epidemiologic findings","volume":"8","author":"DB Jernigan","year":"2002","journal-title":"Emerg Infect Dis"},{"issue":"6","key":"pone.0283164.ref002","doi-asserted-by":"crossref","first-page":"2291","DOI":"10.1073\/pnas.90.6.2291","article-title":"Pathology of inhalational anthrax in 42 cases from the Sverdlovsk outbreak of 1979","volume":"90","author":"FA Abramova","year":"1993","journal-title":"Proc Natl Acad Sci U S A"},{"issue":"5188","key":"pone.0283164.ref003","doi-asserted-by":"crossref","first-page":"1202","DOI":"10.1126\/science.7973702","article-title":"The Sverdlovsk anthrax outbreak of 1979","volume":"266","author":"M Meselson","year":"1994","journal-title":"Science"},{"volume-title":"Medical Aspects of Chemical and Biological Warfare: Textbook of Military Medicine, Part I","year":"1997","author":"AM Friedlander","key":"pone.0283164.ref004"},{"key":"pone.0283164.ref005","doi-asserted-by":"crossref","first-page":"399","DOI":"10.1001\/jama.1997.03550050061035","article-title":"Clinical recognition and management of patients exposed to biological warfare agents","volume":"278","author":"DR Franz","year":"1997","journal-title":"JAMA"},{"key":"pone.0283164.ref006","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1177\/0272989X08315245","article-title":"Modeling the Incubation Period of Inhalational Anthrax","volume":"28","author":"DA Wilkening","year":"2008","journal-title":"Med Decis Making"},{"issue":"8","key":"pone.0283164.ref007","doi-asserted-by":"crossref","first-page":"e1003555","DOI":"10.1371\/journal.ppat.1003555","article-title":"Quantitative Models of the Dose-Response and Time Course of Inhalational Anthrax in Humans.","volume":"9","author":"DJA Toth","year":"2013","journal-title":"PLoS Pathog"},{"issue":"17","key":"pone.0283164.ref008","doi-asserted-by":"crossref","first-page":"2236","DOI":"10.1001\/jama.287.17.2236","article-title":"Anthrax as a biological weapon, 2002: updated recommendations for management","volume":"287","author":"TV Inglesby","year":"2002","journal-title":"JAMA"},{"key":"pone.0283164.ref009","doi-asserted-by":"crossref","first-page":"485","DOI":"10.1002\/path.1700730219","article-title":"The pathogenesis of anthrax following the administration of spores by the respiratory route","volume":"73","author":"JM Ross","year":"1957","journal-title":"J Pathol Bacteriol"},{"key":"pone.0283164.ref010","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1111\/j.1749-6632.1980.tb18910.x","article-title":"Inhalation anthrax","volume":"353","author":"PS Brachman","year":"1980","journal-title":"Ann N Y Acad Sci"},{"key":"pone.0283164.ref011","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1099\/00221287-22-1-206","article-title":"Purification of factors I and II of the anthrax toxin produced in vivo","volume":"22","author":"JL Stanley","year":"1960","journal-title":"J. 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