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Safety evaluation of standardized allergen extract of Japanese cedar pollen for sublingual immunotherapy.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Mitobe, Yuko Yokomoto, Yasuki Ohashi-Doi, Katsuyo
Description	Author Affiliation: Mitobe Y ( Research Laboratory, Torii Pharmaceutical Co., Ltd., 2183-1 Teranosaku, Ota, Sakura, Chiba 285-0808, Japan); Yokomoto Y ( Toxicology Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc., 23-Naganuki, Hadanoshi, Kanagawa 257-0014, Japan.); Ohashi-Doi K ( Research Laboratory, Torii Pharmaceutical Co., Ltd., 2183-1 Teranosaku, Ota, Sakura, Chiba 285-0808, Japan.)
Abstract	Japanese cedar (JC) pollinosis is caused by Japanese cedar pollen (JCP) and most common seasonal allergic disease in Japan. Subcutaneous immunotherapy (SCIT) with allergen extract of JCP (JCP-allergen extract) is well established for JC pollinosis treatment with improvement of symptoms. However, major drawbacks for SCIT are repeated painful injections, frequent hospital visits and anaphylactic risk. Currently, sublingual immunotherapy (SLIT) has received much attention as an advanced alternative application with lower incidence of systemic reactions because the liquid or tablet form of allergen is placed under the tongue. The aim of this study was safety evaluation of standardized JCP-allergen extract currently developed for SLIT in JC pollinosis. JCP-allergen extract showed no potential genotoxicity. No systemic effects were observed in rats administered JCP-allergen extract orally for 26 weeks followed by 4-week recovery period. Mild local reactions such as hyperplasia and increased globule leukocytes resulting from vehicle (glycerin)-induced irritation were observed in stomach. No-observed-adverse-effect level was greater than 10,000 JAU/kg/day for systemic toxicity, equivalent to 300-fold the human dose. No local irritation was found in rabbits oral mucosae by 7-day sublingual administration. These results demonstrate the safe profile of standardized JCP-allergen extract, suggesting it is suitable for SLIT in JC pollinosis.
File Format	HTM / HTML
ISSN	02732300
Issue Number	3
Volume Number	71
e-ISSN	10960295
Journal	Regulatory Toxicology and Pharmacology
Language	English
Publisher	Elsevier
Publisher Date	2015-04-01
Publisher Place	Netherlands
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Allergens Toxicity Cryptomeria Immunology Pollen Rhinitis, Allergic, Seasonal Drug Therapy Sublingual Immunotherapy Adverse Effects Administration, Oral Administration & Dosage Animals Cell Line Cricetinae Dna, Bacterial Drug Effects Genetics Dose-response Relationship, Drug Escherichia Coli Humans Injections, Intradermal Male Micronuclei, Chromosome-defective Chemically Induced Micronucleus Tests Mouth Mucosa Mutation No-observed-adverse-effect Level Passive Cutaneous Anaphylaxis Rabbits Rats, Sprague-dawley Risk Assessment Salmonella Typhimurium Methods Time Factors Journal Article
Content Type	Text
Resource Type	Article
Subject	Medicine Toxicology

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