{"id":"https://openalex.org/W4412398457","doi":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44","title":"Assessment of the allergenic and immunotoxic properties of the recombinant non-immunogenic staphylokinase in preclinical and clinical trials","display_name":"Assessment of the allergenic and immunotoxic properties of the recombinant non-immunogenic staphylokinase in preclinical and clinical trials","publication_year":2025,"publication_date":"2025-07-11","ids":{"openalex":"https://openalex.org/W4412398457","doi":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44"},"language":"en","primary_location":{"id":"doi:10.19163/2307-9266-2025-13-1-31-44","doi":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44","is_oa":true,"landing_page_url":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44","pdf_url":"https://www.pharmpharm.ru/jour/article/download/1674/1085","source":{"id":"https://openalex.org/S2737365290","display_name":"Pharmacy & Pharmacology","issn_l":"2307-9266","issn":["2307-9266","2413-2241"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","dongbi-d","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4310312629","host_organization_name":"Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical University","host_organization_lineage":["https://openalex.org/P4310312629"],"host_organization_lineage_names":["Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical University"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacy & Pharmacology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://www.pharmpharm.ru/jour/article/download/1674/1085","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5058426137","display_name":"Sergey S. Markin","orcid":"https://orcid.org/0000-0002-0242-0282","observed_orcids":["https://orcid.org/0000-0002-0242-0282"]},"institutions":[{"id":"https://openalex.org/I4210152028","display_name":"Institute of Biomedical Chemistry","ror":"https://ror.org/040wrkp27","country_code":"RU","type":"facility","lineage":["https://openalex.org/I1313323035","https://openalex.org/I4210110862","https://openalex.org/I4210152028"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"S. S. Markin","raw_affiliation_strings":["1. Institute of Biomedical Chemistry.\r\n2. SuperGene"],"raw_orcid":"https://orcid.org/0000-0002-0242-0282","affiliations":[{"raw_affiliation_string":"1. Institute of Biomedical Chemistry.\r\n2. SuperGene","institution_ids":["https://openalex.org/I4210152028"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5024484596","display_name":"\u0421\u0435\u0440\u0433\u0435\u0439 \u0412\u0438\u0442\u0430\u043b\u044c\u0435\u0432\u0438\u0447 \u0418\u0432\u0430\u043d\u043e\u0432","orcid":"https://orcid.org/0000-0003-0438-9108","observed_orcids":["https://orcid.org/0000-0003-0438-9108"]},"institutions":[{"id":"https://openalex.org/I4210152028","display_name":"Institute of Biomedical Chemistry","ror":"https://ror.org/040wrkp27","country_code":"RU","type":"facility","lineage":["https://openalex.org/I1313323035","https://openalex.org/I4210110862","https://openalex.org/I4210152028"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"S. V. Ivanov","raw_affiliation_strings":["1. Institute of Biomedical Chemistry.\r\n2. SuperGene"],"raw_orcid":"https://orcid.org/0000-0003-0438-9108","affiliations":[{"raw_affiliation_string":"1. Institute of Biomedical Chemistry.\r\n2. SuperGene","institution_ids":["https://openalex.org/I4210152028"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5003133591","display_name":"Igor P. Beletsky","orcid":"https://orcid.org/0000-0003-0248-1840","observed_orcids":["https://orcid.org/0000-0003-0248-1840"]},"institutions":[{"id":"https://openalex.org/I1313323035","display_name":"Russian Academy of Sciences","ror":"https://ror.org/05qrfxd25","country_code":"RU","type":"government","lineage":["https://openalex.org/I1313323035"]},{"id":"https://openalex.org/I4210088122","display_name":"Institute of Theoretical and Experimental Biophysics","ror":"https://ror.org/008ebms37","country_code":"RU","type":"facility","lineage":["https://openalex.org/I1313323035","https://openalex.org/I4210088122","https://openalex.org/I4210129690"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"I. P. Beletsky","raw_affiliation_strings":["Institute of Theoretical and Experimental Biophysics of Russian Academy of Sciences"],"raw_orcid":"https://orcid.org/0000-0003-0248-1840","affiliations":[{"raw_affiliation_string":"Institute of Theoretical and Experimental Biophysics of Russian Academy of Sciences","institution_ids":["https://openalex.org/I1313323035","https://openalex.org/I4210088122"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5070204492","display_name":"Marina V. Zakharova","orcid":"https://orcid.org/0000-0003-0158-7088","observed_orcids":["https://orcid.org/0000-0003-0158-7088"]},"institutions":[{"id":"https://openalex.org/I4210158654","display_name":"G. K. Skryabin Institute of Biochemistry and Physiology of Microorganisms","ror":"https://ror.org/048zssa22","country_code":"RU","type":"facility","lineage":["https://openalex.org/I1313323035","https://openalex.org/I4210129690","https://openalex.org/I4210158654"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"M. V. Zakharova","raw_affiliation_strings":["Skryabin Institute of Biochemistry and Physiology of Microorganisms"],"raw_orcid":"https://orcid.org/0000-0003-0158-7088","affiliations":[{"raw_affiliation_string":"Skryabin Institute of Biochemistry and Physiology of Microorganisms","institution_ids":["https://openalex.org/I4210158654"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5059567641","display_name":"\u041f\u043e\u043d\u043e\u043c\u0430\u0440\u0435\u0432 \u042d\u0434\u0443\u0430\u0440\u0434 \u0410\u043b\u0435\u043a\u0441\u0435\u0435\u0432\u0438\u0447","orcid":"https://orcid.org/0000-0001-8391-6193","observed_orcids":["https://orcid.org/0000-0001-8391-6193"]},"institutions":[{"id":"https://openalex.org/I155623535","display_name":"Volgograd State Medical University","ror":"https://ror.org/04q6a0352","country_code":"RU","type":"education","lineage":["https://openalex.org/I155623535"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"E. A. Ponomarev","raw_affiliation_strings":["1. City Clinical Hospital of Emergency Medicine No. 25.\r\n2. Volgograd State Medical University"],"raw_orcid":"https://orcid.org/0000-0001-8391-6193","affiliations":[{"raw_affiliation_string":"1. City Clinical Hospital of Emergency Medicine No. 25.\r\n2. Volgograd State Medical University","institution_ids":["https://openalex.org/I155623535"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5006156717","display_name":"E. V. Arzamascev","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210147235","display_name":"National Medical Research Center of Cardiology","ror":"https://ror.org/04f17cx55","country_code":"RU","type":"facility","lineage":["https://openalex.org/I4210117042","https://openalex.org/I4210147235"]}],"countries":["RU"],"is_corresponding":false,"raw_author_name":"E. V. Arzamascev","raw_affiliation_strings":["National Medical Research Center of Cardiology named after Academician E.I. Chazov"],"raw_orcid":"https://orcid.org/0000-0002-1270-3067","affiliations":[{"raw_affiliation_string":"National Medical Research Center of Cardiology named after Academician E.I. Chazov","institution_ids":["https://openalex.org/I4210147235"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":6,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":3.1155,"has_fulltext":true,"cited_by_count":10,"citation_normalized_percentile":{"value":0.9197638,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":93,"max":99},"biblio":{"volume":"13","issue":"1","first_page":"31","last_page":"44"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14072","display_name":"Immunotoxicology and immune responses","score":0.3668999969959259,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T14072","display_name":"Immunotoxicology and immune responses","score":0.3668999969959259,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11117","display_name":"Drug-Induced Adverse Reactions","score":0.336899995803833,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology (medical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10634","display_name":"Food Allergy and Anaphylaxis Research","score":0.09690000116825104,"subfield":{"id":"https://openalex.org/subfields/2723","display_name":"Immunology and Allergy"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/recombinant-staphylokinase","display_name":"recombinant staphylokinase","score":0.8889999985694885},{"id":"https://openalex.org/keywords/allergenicity","display_name":"allergenicity","score":0.7760000228881836},{"id":"https://openalex.org/keywords/immunotoxicity","display_name":"immunotoxicity","score":0.996999979019165},{"id":"https://openalex.org/keywords/amino-acid-substitutions","display_name":"amino acid substitutions","score":0.5490000247955322},{"id":"https://openalex.org/keywords/acute-st-segment-elevation-myocardial-infarction","display_name":"acute ST-segment elevation myocardial infarction","score":0.8820000290870667},{"id":"https://openalex.org/keywords/anti-drug-antibodies","display_name":"anti-drug antibodies","score":0.5789999961853027},{"id":"https://openalex.org/keywords/immediate-hypersensitivity","display_name":"immediate hypersensitivity","score":0.5640000104904175},{"id":"https://openalex.org/keywords/delayed-type-hypersensitivity","display_name":"delayed-type hypersensitivity","score":0.8970000147819519},{"id":"https://openalex.org/keywords/lymphocyte-proliferation","display_name":"lymphocyte proliferation","score":0.5049999952316284},{"id":"https://openalex.org/keywords/guinea-pig-skin-test","display_name":"guinea pig skin test","score":0.5080000162124634},{"id":"https://openalex.org/keywords/recombinant-protein","display_name":"recombinant protein","score":0.40799999237060547}],"concepts":[{"id":"https://openalex.org/C2779440172","wikidata":"https://www.wikidata.org/wiki/Q906585","display_name":"Staphylokinase","level":4,"score":0.8778278827667236},{"id":"https://openalex.org/C40767141","wikidata":"https://www.wikidata.org/wiki/Q285697","display_name":"Recombinant DNA","level":3,"score":0.7223379015922546},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.5281351208686829},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.46862295269966125},{"id":"https://openalex.org/C159047783","wikidata":"https://www.wikidata.org/wiki/Q7215","display_name":"Virology","level":1,"score":0.3903239965438843},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.37265458703041077},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.36807823181152344},{"id":"https://openalex.org/C70721500","wikidata":"https://www.wikidata.org/wiki/Q177005","display_name":"Computational biology","level":1,"score":0.3350127339363098},{"id":"https://openalex.org/C60644358","wikidata":"https://www.wikidata.org/wiki/Q128570","display_name":"Bioinformatics","level":1,"score":0.12718957662582397},{"id":"https://openalex.org/C104317684","wikidata":"https://www.wikidata.org/wiki/Q7187","display_name":"Gene","level":2,"score":0.11121302843093872},{"id":"https://openalex.org/C54355233","wikidata":"https://www.wikidata.org/wiki/Q7162","display_name":"Genetics","level":1,"score":0.09354779124259949}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.19163/2307-9266-2025-13-1-31-44","doi":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44","is_oa":true,"landing_page_url":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44","pdf_url":"https://www.pharmpharm.ru/jour/article/download/1674/1085","source":{"id":"https://openalex.org/S2737365290","display_name":"Pharmacy & Pharmacology","issn_l":"2307-9266","issn":["2307-9266","2413-2241"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","dongbi-d","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4310312629","host_organization_name":"Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical University","host_organization_lineage":["https://openalex.org/P4310312629"],"host_organization_lineage_names":["Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical University"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacy & Pharmacology","raw_type":"journal-article"},{"id":"pmh:oai:doaj.org/article:71a3dc76913642149991263b460b5468","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/71a3dc76913642149991263b460b5468","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"\u0424\u0430\u0440\u043c\u0430\u0446\u0438\u044f \u0438 \u0444\u0430\u0440\u043c\u0430\u043a\u043e\u043b\u043e\u0433\u0438\u044f (\u041f\u044f\u0442\u0438\u0433\u043e\u0440\u0441\u043a), Vol 13, Iss 1, Pp 31-44 (2025)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.19163/2307-9266-2025-13-1-31-44","doi":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44","is_oa":true,"landing_page_url":"https://doi.org/10.19163/2307-9266-2025-13-1-31-44","pdf_url":"https://www.pharmpharm.ru/jour/article/download/1674/1085","source":{"id":"https://openalex.org/S2737365290","display_name":"Pharmacy & Pharmacology","issn_l":"2307-9266","issn":["2307-9266","2413-2241"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","dongbi-d","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4310312629","host_organization_name":"Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical University","host_organization_lineage":["https://openalex.org/P4310312629"],"host_organization_lineage_names":["Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical University"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacy & Pharmacology","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4412398457.pdf","grobid_xml":"https://content.openalex.org/works/W4412398457.grobid-xml"},"referenced_works_count":24,"referenced_works":["https://openalex.org/W1481390314","https://openalex.org/W1915952657","https://openalex.org/W1968582628","https://openalex.org/W2039333258","https://openalex.org/W2050302630","https://openalex.org/W2103533171","https://openalex.org/W2161863487","https://openalex.org/W2490690855","https://openalex.org/W2624680086","https://openalex.org/W2905274389","https://openalex.org/W3029073144","https://openalex.org/W3193313959","https://openalex.org/W4205862442","https://openalex.org/W4220708985","https://openalex.org/W4245667363","https://openalex.org/W4288776194","https://openalex.org/W4292246806","https://openalex.org/W4294578244","https://openalex.org/W4389249094","https://openalex.org/W4392650026","https://openalex.org/W4403681719","https://openalex.org/W4405471465","https://openalex.org/W4408500345","https://openalex.org/W4413126959"],"related_works":["https://openalex.org/W2405932881","https://openalex.org/W2034639222","https://openalex.org/W2221519426","https://openalex.org/W2359767739","https://openalex.org/W1980175600","https://openalex.org/W4238166192","https://openalex.org/W2101973922","https://openalex.org/W2359100786","https://openalex.org/W2021915803","https://openalex.org/W2062599442"],"abstract_inverted_index":{"The":[0,34,103],"aim.":[1],"To":[2],"study":[3,83,104,119,227],"possible":[4],"allergenic":[5,35,339],"and":[6,22,28,32,36,66,73,117,143,150,179,213,340,348],"immunotoxic":[7,37,341],"properties":[8,38,342],"of":[9,39,59,100,108,110,120,129,173,199,211,219,224,228,238,242,245,263,274,286,299,333,338,343],"the":[10,16,40,53,56,101,106,118,126,136,141,166,196,209,217,239,243,264,284,296,304,309,315,331,334,336,344,354],"recombinant":[11,41,114,229,250,300,345],"non-immunogenic":[12,42,115,230,251,301,346],"staphylokinase":[13,43,116,252,302,347],"molecule":[14],"with":[15,24,52,89],"amino":[17],"acids":[18],"replacement":[19],"Lys74,":[20],"Glu75":[21],"Arg77":[23],"alanine":[25],"in":[26,50,62,86,147,190,216,303,351],"preclinical":[27,130],"clinical":[29,82,226],"studies.":[30],"Materials":[31],"methods.":[33],"drug":[44,137,167,310],"were":[45,235,248,267],"studied":[46],"using":[47],"standard":[48],"methods":[49],"accordance":[51],"Guidelines":[54],"for":[55,160],"Preclinical":[57],"Study":[58],"New":[60],"Substances":[61],"guinea":[63,148,191],"pigs":[64,149],"(n=15)":[65],"mice":[67,151],"(n=45)":[68],"at":[69,152],"doses":[70,153,159],"5,":[71],"10":[72],"20":[74],"times":[75,155,280,293],"higher":[76,156],"than":[77,157,282,295],"therapeutic":[78,158],"(for":[79],"humans).":[80],"A":[81],"was":[84,133,163],"conducted":[85],"100":[87],"patients":[88,246],"acute":[90],"ST-segment":[91],"elevation":[92],"myocardial":[93],"infarction":[94],"after":[95,283],"a":[96,180,222,225,270],"single":[97],"intravenous":[98],"injection":[99],"drug.":[102],"included":[105],"determination":[107],"titers":[109],"specific":[111],"antibodies":[112,318],"to":[113,187,314,321,330,353],"plasma":[121,244],"neutralizing":[122,240,260,272,317],"activity.":[123],"Results.":[124],"During":[125],"complete":[127],"set":[128],"studies,":[131],"it":[132],"found":[134,164],"that":[135,165,254],"does":[138,311],"not":[139,169,194,207,258,312],"affect":[140,195,208],"cellular":[142,197],"humoral":[144],"immune":[145,355],"response":[146],"many":[154],"humans.":[161],"It":[162],"did":[168,193,206,257],"cause":[170],"an":[171],"immediate-type":[172],"hypersensitivity":[174],"reaction":[175],"(Weigle":[176],"index":[177,204],"0)":[178],"delayed":[181],"type":[182],"IV":[183],"(0":[184],"points":[185],"according":[186],"S.V.":[188],"Suvorov)":[189],"pigs,":[192],"capacity":[198],"popliteal":[200],"lymph":[201],"nodes":[202],"(reaction":[203],"0.91),":[205],"number":[210],"nucleated":[212],"antibody-forming":[214],"cells":[215],"spleen":[218],"mice.":[220],"As":[221],"result":[223],"staphylokinase,":[231],"no":[232],"allergic":[233],"reactions":[234],"registered.":[236],"Assessment":[237],"activity":[241,273],"who":[247],"administered":[249],"showed":[253],"70%":[255],"samples":[256,266],"have":[259,357],"activity:":[261],"30%":[262],"patients\u2019":[265],"characterized":[268],"by":[269],"minimum":[271],"0.33\u00b10.02":[275],"\u03bcg/mL,":[276],"which":[277],"is":[278],"30\u2013310":[279],"lower":[281,294],"use":[285],"native":[287],"staphylokinase.":[288],"These":[289],"values":[290],"are":[291],"7.8":[292],"determined":[297],"concentration":[298],"blood":[305],"(2.59":[306],"\u03bcg/mL).":[307],"Thus,":[308],"lead":[313],"anti-staphylokinase":[316],"formation":[319],"capable":[320],"neutralize":[322],"its":[323,349],"effect":[324],"upon":[325],"repeated":[326],"administration.":[327],"Conclusion.":[328],"According":[329],"results":[332],"trials,":[335],"absence":[337],"safety":[350],"relation":[352],"system":[356],"been":[358],"proven.":[359]},"counts_by_year":[{"year":2026,"cited_by_count":8},{"year":2025,"cited_by_count":2}],"updated_date":"2026-11-06T12:05:46.655746","created_date":"2025-10-10T00:00:00"}