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Toxins
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Emerging Botulinum Neurotoxins for Clinical Uses
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Emerging Botulinum Neurotoxins for Clinical Uses

A special issue of Toxins (ISSN 2072-6651). This special issue belongs to the section "Bacterial Toxins".

Deadline for manuscript submissions: closed (31 May 2022) | Viewed by 22008

Special Issue Editor

Prof. Dr. Ryuji Kaji

E-Mail Website
Guest Editor
Department of Neuroscience, Institute of Health-Bioscience, Tokushima University, 2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan
Interests: dystonia; ALS; botulinum toxin therapy
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Botulinum Neurotoxins (BoNTs) are increasingly apllied not only for cosmetic uses and muscle hyperactivities, but also for pain, autonomic dysfunction and others. To meet the expanding clinical needs, several BoNT preparations are in the pipeline for clinical development. We shed light on these projects to acquaint the readers with the future of botulinum toxin therapy.

Prof. Dr. Ryuji Kaji
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a double-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Toxins is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • botulinum neurotoxins
  • clinical applications
  • botulinum toxin therapy
  • dystonia
  • movement disorder
  • spasticity
  • pain
  • new drug

Published Papers (5 papers)

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Research

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13 pages, 2324 KiB  
Article
A Pilot Study of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Subtype A2 for Post-Stroke Lower Limb Spasticity: Comparison with OnabotulinumtoxinA
by Ryuji Kaji, Ai Miyashiro, Nori Sato, Taiki Furumoto, Toshiaki Takeuchi, Ryosuke Miyamoto, Tomoko Kohda, Yuishin Izumi and Shunji Kozaki
Toxins 2022, 14(11), 739; https://0-doi-org.brum.beds.ac.uk/10.3390/toxins14110739 - 28 Oct 2022
Cited by 1 | Viewed by 1489
Abstract
All the currently used type A botulinum neurotoxins for clinical uses are of subtype A1. We compared the efficacy and safety for the first time head-to-head between a novel botulinum toxin A2NTX prepared from subtype A2 and onabotulinumtoxinA (BOTOX) derived from A1 for [...] Read more.
All the currently used type A botulinum neurotoxins for clinical uses are of subtype A1. We compared the efficacy and safety for the first time head-to-head between a novel botulinum toxin A2NTX prepared from subtype A2 and onabotulinumtoxinA (BOTOX) derived from A1 for post-stroke spasticity. We assessed the modified Ashworth scale (MAS) of the ankle joint, the mobility scores of Functional Independence Measure (FIM), and the grip power of the unaffected hand before and after injecting 300 units of BOTOX or A2NTX into calf muscles. The procedure was done in a blinded manner for the patient, the injecting physician, and the examiner. Stroke patients with chronic spastic hemiparesis (15 for A2NTX and 16 for BOTOX) were enrolled, and 11 for A2NTX and 13 for BOTOX (MAS of ankle; > or = 2) were entered for the MAS study. Area-under-curves of changes in MAS (primary outcome) were greater for A2NTX by day 30 (p = 0.044), and were similar by day 60. FIM was significantly improved in the A2NTX group (p = 0.005), but not in the BOTOX group by day 60. The hand grip of the unaffected limb was significantly decreased in the BOTOX-injected group (p = 0.002), but was unaffected in the A2NTX-injected group by day 60, suggesting there was less spread of A2NTX to the upper limb than there was with BOTOX. Being a small-sized pilot investigation with an imbalance in the gender of the subjects, the present study suggested superior efficacy and safety of A2NTX, and warrants a larger scale clinical trial of A2NTX to confirm these preliminary results. Full article
(This article belongs to the Special Issue Emerging Botulinum Neurotoxins for Clinical Uses)
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16 pages, 1945 KiB  
Article
Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis
by Steffen Berweck, Marta Banach, Deborah Gaebler-Spira, Henry G. Chambers, A. S. Schroeder, Thorin L. Geister, Michael Althaus, Angelika Hanschmann, Matteo Vacchelli, Michaela V. Bonfert, Florian Heinen and Edward Dabrowski
Toxins 2022, 14(9), 585; https://0-doi-org.brum.beds.ac.uk/10.3390/toxins14090585 - 25 Aug 2022
Cited by 3 | Viewed by 2714
Abstract
IncobotulinumtoxinA, a pure botulinumtoxinA formulation, is free of accessory proteins. This analysis provides pooled safety data from phase 3 trials of children/adolescents (2–17 years), investigating incobotulinumtoxinA for the treatment of spasticity associated with cerebral palsy (at doses ≤20 U/kg (max. 500 U) per [...] Read more.
IncobotulinumtoxinA, a pure botulinumtoxinA formulation, is free of accessory proteins. This analysis provides pooled safety data from phase 3 trials of children/adolescents (2–17 years), investigating incobotulinumtoxinA for the treatment of spasticity associated with cerebral palsy (at doses ≤20 U/kg (max. 500 U) per injection cycle (IC) for ≤6 ICs; three trials) or sialorrhea associated with neurologic disorders (at total doses of 20–75 U per IC for ≤4 ICs; one trial) for ≤96 weeks. Safety endpoints included the incidences of different types of treatment-emergent adverse events (TEAEs) and immunogenicity. IncobotulinumtoxinA dose groups were combined. Of 1159 patients (mean age 7.3 years, 60.4% males) treated with incobotulinumtoxinA, 3.9% experienced treatment-related TEAEs, with the most common being injection site reactions (1.3%) (both indications), muscular weakness (0.7%) (spasticity), and dysphagia (0.2%) (sialorrhea). Two patients (0.2%) experienced a treatment-related treatment-emergent serious adverse event, and 0.3% discontinued the study due to treatment-related TEAEs. No botulinumtoxinA-naïve patients developed neutralizing antibodies (NAbs) after incobotulinumtoxinA. All children/adolescents with known pre-treatment status and testing positive for Nabs at final visit (n = 7) were previously treated with a botulinumtoxinA other than incobotulinumtoxinA. IncobotulinumtoxinA was shown to be safe, with very few treatment-related TEAEs in a large, diverse cohort of children/adolescents with chronic conditions requiring long-term treatment and was without new NAb formation in treatment-naïve patients. Full article
(This article belongs to the Special Issue Emerging Botulinum Neurotoxins for Clinical Uses)
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11 pages, 871 KiB  
Article
Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
by Toshiaki Takeuchi, Tsuyoshi Okuno, Ai Miyashiro, Tomoko Kohda, Ryosuke Miyamoto, Yuishin Izumi, Shunji Kozaki and Ryuji Kaji
Toxins 2021, 13(11), 824; https://0-doi-org.brum.beds.ac.uk/10.3390/toxins13110824 - 22 Nov 2021
Cited by 3 | Viewed by 2130
Abstract
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 [...] Read more.
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. Full article
(This article belongs to the Special Issue Emerging Botulinum Neurotoxins for Clinical Uses)
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Review

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10 pages, 2061 KiB  
Review
Botulinum Toxin Therapy for Spasmodic Dysphonia in Japan: The History and an Update
by Masamitsu Hyodo, Kahori Hirose, Asuka Nagao, Maya Nakahira and Taisuke Kobayashi
Toxins 2022, 14(7), 451; https://0-doi-org.brum.beds.ac.uk/10.3390/toxins14070451 - 01 Jul 2022
Cited by 4 | Viewed by 2865
Abstract
Spasmodic dysphonia (SD) is a rare neurological disorder that impairs phonatory function by triggering involuntary and intermittent contractions of the intrinsic laryngeal muscles. SD is classified into three types: adductor SD (AdSD), abductor SD (AbSD), and mixed SD. Of these, AdSD accounts for [...] Read more.
Spasmodic dysphonia (SD) is a rare neurological disorder that impairs phonatory function by triggering involuntary and intermittent contractions of the intrinsic laryngeal muscles. SD is classified into three types: adductor SD (AdSD), abductor SD (AbSD), and mixed SD. Of these, AdSD accounts for 90–95% of disease; younger females are predominantly affected. Botulinum toxin injection into the laryngeal muscles is safe, minimally invasive, and very effective. Here, we review the history of clinical research for SD conducted in Japan. The first use of botulinum toxin injection therapy to treat SD in Japan was by Kobayashi et al. in 1989. The group developed an objective mora (syllable) method to evaluate SD severity. Recently, we conducted a placebo-controlled, randomized, double-blinded clinical trial of botulinum toxin therapy for AdSD and an open-label trial for AbSD to obtain the approval of such therapy by the Japanese medical insurance system. The mora method revealed significant voice improvement and the evidence was of high quality. Additionally, a clinical trial of type 2 thyroplasty using titanium bridges confirmed the efficacy and safety of such therapy. These studies broadened the SD treatment options and have significantly benefited patients. Full article
(This article belongs to the Special Issue Emerging Botulinum Neurotoxins for Clinical Uses)
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23 pages, 6609 KiB  
Review
Ultrasound Imaging of the Facial Muscles and Relevance with Botulinum Toxin Injections: A Pictorial Essay and Narrative Review
by Wei-Ting Wu, Ke-Vin Chang, Hsiang-Chi Chang, Lan-Rong Chen, Chen-Hsiang Kuan, Jung-Ting Kao, Ling-Ying Wei, Yunn-Jy Chen, Der-Sheng Han and Levent Özçakar
Toxins 2022, 14(2), 101; https://0-doi-org.brum.beds.ac.uk/10.3390/toxins14020101 - 27 Jan 2022
Cited by 11 | Viewed by 12178
Abstract
High-resolution ultrasound is preferred as the first-line imaging modality for evaluation of superficial soft tissues, such as the facial muscles. In contrast to magnetic resonance imaging and computed tomography, which require specifically designated planes (axial, coronal and sagittal) for imaging, the ultrasound transducer [...] Read more.
High-resolution ultrasound is preferred as the first-line imaging modality for evaluation of superficial soft tissues, such as the facial muscles. In contrast to magnetic resonance imaging and computed tomography, which require specifically designated planes (axial, coronal and sagittal) for imaging, the ultrasound transducer can be navigated based on the alignment of facial muscles. Botulinum toxin injections are widely used in facial cosmetic procedures in recent times. Ultrasonography is recognized as a useful tool for pre-procedure localization of target muscles. In this pictorial review, we discuss the detailed sonoanatomy of facial muscles and their clinical relevance, particularly with regard to botulinum toxin injections. Furthermore, we have summarized the findings of clinical studies that report ultrasonographic imaging of facial muscles. Full article
(This article belongs to the Special Issue Emerging Botulinum Neurotoxins for Clinical Uses)
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