- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
Journal: Exposure-Response Modeling and Simulation to Support Human Dosing of Botulism Antitoxin Heptavalent Product. (Pubmed Central) - Jun 22, 2022
Furthermore, this BAT product dose is expected to result in a significant protection against clinical signs in human adults for all botulinum neurotoxin serotypes. Our exposure response model indicates that we have sufficient antitoxin levels to give full protection at various theoretical exposure levels and based on neutralization capacity/potency of one dose of BAT product it is expected to exceed the amount of circulating botulinum neurotoxin.
- |||||||||| BAT (botulism antitoxin heptavalent) / Emergent Biosolutions
Enrollment closed, Trial completion date, Trial primary completion date: BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients (clinicaltrials.gov) - May 6, 2022
P4, N=7, Active, not recruiting,
Our exposure response model indicates that we have sufficient antitoxin levels to give full protection at various theoretical exposure levels and based on neutralization capacity/potency of one dose of BAT product it is expected to exceed the amount of circulating botulinum neurotoxin. Completed --> Active, not recruiting | Trial completion date: Jul 2017 --> Jul 2027 | Trial primary completion date: Jul 2017 --> Jul 2027
- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
Clinical, Review, Journal, Adverse events: Use of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) (BAT) in Clinical Study Subjects and Patients: A 15-Year Systematic Safety Review. (Pubmed Central) - Mar 3, 2022
For patients properly managed in an intensive care setting, the advantages of BAT product appear to outweigh potential risks in patients due to morbidity and mortality of botulism. AEs of special interest, including bradycardia, hemodynamic instability, hypersensitivity, serum sickness, and febrile reactions in the registry, were specifically solicited.
- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
Journal: Outbreak of foodborne botulism in Alexandria, Egypt: modulating indications for administration of heptavalent botulinum antitoxin. (Pubmed Central) - Nov 17, 2021
In an attempt to allocate the resources, not all patients were given HBAT (botulism antitoxin heptavalent (A, B, C, D, E, F, G) equine immediately...However, eighty-two (87.2%) of patients were completely cured, whereas ten patients (10.6%) were discharged with mild neurological sequels and death occurred only in two cases (2.2%). Sixty cases (63.8%) with suspected foodborne botulism could be managed by supportive treatment only with no need for HBAT, while patients with evident neurological signs received HBAT immediately.
- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
Clinical, Journal: Wound Botulism in Black Tar Heroin Injecting Users: A Case Series. (Pubmed Central) - Oct 20, 2021
In this article, we present 3 cases of wound botulism, in which the patients presented with bulbar weakness and were treated with botulism antitoxin heptavalent. The time to antitoxin administration and its effect on the patients' clinical courses is compared.
- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
[VIRTUAL] Wound botulism in black TAR heroin injecting users () - Jan 6, 2021 - Abstract #WSMRF2021WSMRF_498;
If there is high clinical suspicion, a prompt administration of botulism antitoxin heptavalent (BAT) should be considered...The history of drug injection and signs of infection especially around the drug injecting sites further increase the suspicion. The timely administration of BAT can significantly lessen the duration and severity of wound botulism.
- |||||||||| Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] IATROGENIC BOTULISM () - Oct 12, 2020 - Abstract #CHEST2020CHEST_1514;
The patient was administered the Botulism Antitoxin Heptavalent antibody (BAT). Patients with compromised respiratory status treated with BOTOX injections for spasticity should be monitored closely.
- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
Journal, HEOR: Cost savings associated with timely treatment of botulism with botulism antitoxin heptavalent product. (Pubmed Central) - Mar 19, 2020
Substantial economic savings can be achieved with early BAT product treatment. The findings support the recommendation for public health authorities to ensure antitoxin treatment is readily available in sufficient quantities to manage botulism cases, including sporadic outbreaks and potential mass exposure biological attacks.
- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
Clinical, Journal: Therapeutic efficacy of equine botulism heptavalent antitoxin against all seven botulinum neurotoxins in symptomatic guinea pigs. (Pubmed Central) - Mar 8, 2020
BAT product treatment significantly (p<0.0001) enhanced survival compared to placebo for all botulinum neurotoxin serotypes and arrested or mitigated the progression of clinical signs of botulism intoxication. These results demonstrated the therapeutic efficacy of BAT product in guinea pigs and provided supporting evidence of effectiveness for licensure of BAT product under FDA 21 CFR Part 601 (Subpart H Animal Rule) as a therapeutic for botulism intoxication to serotypes A, B, C, D, E, F or G in adults and pediatric patients.
- |||||||||| botulism antitoxin heptavalent (NP-018) / Emergent Biosolutions
Clinical, Journal: Efficacy of equine botulism antitoxin in botulism poisoning in a guinea pig model. (Pubmed Central) - Sep 26, 2019
These results demonstrated the therapeutic efficacy of BAT product in guinea pigs and provided supporting evidence of effectiveness for licensure of BAT product under FDA 21 CFR Part 601 (Subpart H Animal Rule) as a therapeutic for botulism intoxication to serotypes A, B, C, D, E, F or G in adults and pediatric patients. These studies confirm the efficacy of BAT as a post-exposure prophylactic therapy against all seven known BoNT serotypes.
- |||||||||| BAT (botulism antitoxin heptavalent) / Emergent Biosolutions
Trial completion, Enrollment change, Trial primary completion date: BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients (clinicaltrials.gov) - Jan 26, 2018
P4, N=3, Completed,
These studies confirm the efficacy of BAT as a post-exposure prophylactic therapy against all seven known BoNT serotypes. Enrolling by invitation --> Completed | N=10 --> 3 | Trial primary completion date: Oct 2017 --> Jul 2017
- |||||||||| BAT (botulism antitoxin heptavalent) / Emergent Biosolutions
Enrollment open, Phase classification, Trial initiation date, Trial primary completion date: BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients (clinicaltrials.gov) - Dec 29, 2014
P=N/A, N=10, Enrolling by invitation,
Phase classification: P=N/A --> P4 Not yet recruiting --> Enrolling by invitation | Phase classification: P4 --> PN/A | Initiation date: Feb 2014 --> Oct 2014 | Trial primary completion date: Jan 2017 --> Oct 2017
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