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Review, Journal: Effects of poloxamer 188 on traumatic brain injury. (Pubmed Central) - Apr 9, 2024
These articles have shown direct protective effects of P188 on brain tissue following TBI, including restitution of the increase cell membrane permeability, attenuation of neuronal necrosis and apoptosis, improvement of mitochondrial viability, reduction in axonal disruption, and restoration of the blood brain barrier. In animals, P188 has been shown to improve sensorimotor functions, as well as spatial learning and memory.
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Preclinical, Journal: Treatment of stroke in aged male and female rats with Vepoloxamer and tPA reduces neurovascular damage. (Pubmed Central) - Oct 24, 2023
Combination treatment with tPA and Vepoloxamer at 4?h after stroke onset effectively reduces ischemic neurovascular damage by accelerating thrombolysis and reducing ischemia and tPA potentiated side effects in the aged rats. This funding suggests that the combination treatment with tPA and Vepoloxamer represents a promising strategy to potentially apply to the general population of stroke patients.
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Journal: Can red blood cell function assays assess response to red cell-modifying therapies? (Pubmed Central) - Feb 23, 2022
This funding suggests that the combination treatment with tPA and Vepoloxamer represents a promising strategy to potentially apply to the general population of stroke patients. This study demonstrates that the standardized flow adhesion and mechanical fragility biomarkers described here may be useful tools to predict clinical responders to RBC-modifying therapies.
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Journal: Vepoloxamer Enhances Fibrinolysis of tPA (Tissue-Type Plasminogen Activator) on Acute Ischemic Stroke. (Pubmed Central) - Apr 10, 2020
Conclusions- The combination treatment with vepoloxamer and tPA exerts potent thrombolytic effects in rats subjected to acute ischemic stroke. Vepoloxamer reduces tPA-aggravated prothrombotic effect of platelet-derived exosomes on cerebral endothelial cells, which may contribute to the therapeutic effect of the combination treatment.
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Journal: Treatment of traumatic brain injury with vepoloxamer (Purified Poloxamer 188). (Pubmed Central) - Jul 11, 2019
In summary, vepoloxamer treatment initiated 2 h post injury provides neuroprotection and anti-inflammation in rats after TBI and improves functional outcome, indicating that vepoloxamer treatment may have potential value for treatment of TBI. Further investigation of the optimal dose and therapeutic window of vepoloxamer treatment for TBI and the mechanisms underlying beneficial effects are warranted.
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Trial completion: Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer (clinicaltrials.gov) - Dec 22, 2016
P1, N=27, Completed,
Further investigation of the optimal dose and therapeutic window of vepoloxamer treatment for TBI and the mechanisms underlying beneficial effects are warranted. Active, not recruiting --> Completed
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Trial completion, Enrollment change, Trial primary completion date: EPIC-E: Evaluation of Repeat Administration of Purified Poloxamer 188 (clinicaltrials.gov) - Oct 28, 2016
P3, N=16, Completed,
Recruiting --> Completed Recruiting --> Completed | N=388 --> 16 | Trial primary completion date: Jun 2016 --> Sep 2016
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Enrollment change, Trial termination, Trial primary completion date: Evaluation of Vepoloxamer in Chronic Heart Failure (clinicaltrials.gov) - Oct 28, 2016
P2, N=10, Terminated,
Recruiting --> Completed | N=388 --> 16 | Trial primary completion date: Jun 2016 --> Sep 2016 N=150 --> 10 | Recruiting --> Terminated | Trial primary completion date: Mar 2017 --> Oct 2016; Terminated for administrative reasons not related to safety or efficacy
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Enrollment closed, Enrollment change, Trial primary completion date: Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer (clinicaltrials.gov) - Oct 28, 2016
P1, N=27, Active, not recruiting,
N=150 --> 10 | Recruiting --> Terminated | Trial primary completion date: Mar 2017 --> Oct 2016; Terminated for administrative reasons not related to safety or efficacy Recruiting --> Active, not recruiting | N=40 --> 27 | Trial primary completion date: Jun 2016 --> Oct 2016
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Enrollment change, Trial termination: Evaluation of MST-188 in Acute Lower Limb Ischemia (clinicaltrials.gov) - Dec 15, 2015
P2, N=4, Terminated,
Not yet recruiting --> Recruiting N=60 --> 4 | Recruiting --> Terminated; Program discontinued to persue alternate indications.
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Trial primary completion date: Evaluation of MST-188 in Acute Lower Limb Ischemia (clinicaltrials.gov) - Jun 11, 2015
P2, N=60, Recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2015 --> Dec 2016
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Trial completion, Enrollment change: ANX-188 Thorough QT/QTc Study in Healthy Volunteers (clinicaltrials.gov) - May 20, 2015
P1, N=72, Completed,
Trial primary completion date: Oct 2015 --> Dec 2016 Active, not recruiting --> Completed | N=60 --> 72
- |||||||||| vepoloxamer (MST-188) / Savara
Enrollment open, Trial initiation date: Evaluation of MST-188 in Acute Lower Limb Ischemia (clinicaltrials.gov) - Jul 16, 2014
P2, N=60, Recruiting,
Active, not recruiting --> Completed | N=60 --> 72 Not yet recruiting --> Recruiting | Initiation date: Mar 2014 --> Jun 2014
- |||||||||| vepoloxamer (MST-188) / Savara
Enrollment closed: ANX-188 Thorough QT/QTc Study in Healthy Volunteers (clinicaltrials.gov) - Apr 21, 2013
P1, N=60, Active, not recruiting,
Initiation date: Jan 2013 --> May 2013 Recruiting --> Active, not recruiting
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