Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins

• Material Type: 博士論文
• Title: Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
• Author/Editor: Takeuchi, Toshiaki; Okuno, Tsuyoshi; Miyashiro, Ai; Kohda, Tomoko; Miyamoto, Ryosuke; Izumi, Yuishin; Kozaki, Shunji; Kaji, Ryuji
• Author Heading: Takeuchi, Toshiaki; Okuno, Tsuyoshi; Miyashiro, Ai; Kohda, Tomoko; Miyamoto, Ryosuke; Izumi, Yuishin; Kozaki, Shunji; Kaji, Ryuji
• Publication, Distribution, etc.: MDPI
• Publication Date: 2021-11-22
• Publication Date (W3CDTF): 2021-11-22
• Alternative Title: A1型毒素との比較でボツリヌス神経毒素A2型、新規低分子量神経毒素A2NTXの臨床安全性と忍容性
• Periodical title: Toxins
• No. or year of volume/issue: 13 11
• Volume: 13
• Issue: 11
• Pages: 824-
• ISSN (Periodical Title): ISSN : 2072-6651
• Degree grantor/type: 徳島大学
• Date Granted: 2022-04-28
• Dissertation Number: 甲第3638号
• Degree Type: 博士（医学）
• Text Language Code: eng
• Subject Heading: botulinum toxin; subtype A2; clinical tolerability; safety; patients
• Target Audience: 一般
• Note (General): All the botulinum type A neurotoxins available for clinical use are of the A1 subtype. We developed a subtype A2 low-molecular-weight (150 kD (kilo Dalton)) neurotoxin (A2NTX) with less spread and faster entry into the motor nerve terminal than A1 in vitro and in vivo. Preliminary clinical studies showed that its efficacy is superior to A1 toxins. We conducted an open study exploring its safety and tolerability profile in comparison with A1LL (LL type A1 toxin, or onabotulinumtoxinA) and a low-molecular-weight (150 kD) A1 neurotoxin (A1NTX). Those who had been using A1LL (n = 90; 50–360 mouse LD50 units) or A1NTX (n = 30; 50–580 units) were switched to A2NTX (n = 120; 25–600 units) from 2010 to 2018 (number of sessions ~27, cumulative doses ~11,640 units per patient). The adverse events for A2NTX included weakness (n = 1, ascribed to alcoholic polyneuropathy), dysphagia (1), local weakness (4), and spread to other muscles (1), whereas those for A1LL or A1NTX comprised weakness (n = 2, A1NTX), dysphagia (8), ptosis (6), local weakness (7), and spread to other muscles (15). After injections, 89 out of 120 patients preferred A2NTX to A1 for the successive sessions. The present study demonstrated that A2NTX had clinical safety up to the dose of 500 units and was well tolerated compared to A1 toxins
• Format (IMT): application/pdf
• Access Restrictions: インターネット公開
• Rights (production): This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) License (https://creativecommons.org/licenses/by/4.0/).
• Related Material (DOI): 10.3390/toxins13110824
• Data Provider (Database): 国立情報学研究所 : 学術機関リポジトリデータベース（IRDB）（機関リポジトリ）; https://irdb.nii.ac.jp
• Original Data Provider (Database): 徳島大学 : 徳島大学機関リポジトリ

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http://repo.lib.tokushima-u.ac.jp/files/public/11/117149/20220602143514363999/k3638_abstract.pdf fulltext

http://repo.lib.tokushima-u.ac.jp/files/public/11/117149/20220602143514683038/k3638_review.pdf fulltext

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