Literature DB >> 30458059

A pilot trial of RNS60 in amyotrophic lateral sclerosis.

Sabrina Paganoni1,2, Mohamad J Alshikho1,3, Sarah Luppino1, James Chan4, Lindsay Pothier1, David Schoenfeld4, Patricia L Andres1, Suma Babu1, Nicole R Zürcher3, Marco L Loggia3, Robert L Barry3, Silvia Luotti5, Giovanni Nardo5, Maria Chiara Trolese5, Serena Pantalone5, Caterina Bendotti5, Valentina Bonetto5, Fabiola De Marchi1, Bruce Rosen3, Jacob Hooker3, Merit Cudkowicz1, Nazem Atassi1.   

Abstract

INTRODUCTION: RNS60 is a novel immune-modulatory agent that has shown neuroprotective effects in amytrophic lateral sclerosis (ALS) preclinical models. RNS60 is administered by weekly intravenous infusion and daily nebulization. The objective of this pilot open-label trial was to test the feasibility, safety, and tolerability of long-term RNS60 administration in ALS patients.
METHODS: The planned treatment duration was 23 weeks and the primary outcomes were safety and tolerability. Secondary outcomes included PBR28 positron emission tomography (PET) imaging and plasma biomarkers of inflammation.
RESULTS: Sixteen participants with ALS received RNS60 and 13 (81%) completed 23 weeks of RNS60 treatment. There were no serious adverse events and no participants withdrew from the trial due to drug-related adverse events. There were no significant changes in the biomarkers. DISCUSSION: Long-term RNS60 administration was safe and well-tolerated. A large, multicenter, phase II trial of RNS60 is currently enrolling participants to test the effects of RNS60 on ALS biomarkers and disease progression. Muscle Nerve 59:303-308, 2019.
© 2018 Wiley Periodicals, Inc.

Entities:  

Keywords:  ALS; PBR28; clinical trial; motor neuron disease (MND); neuroinflammation

Mesh：

Substances：

Year:  2018        PMID： 30458059      PMCID： PMC6379136          DOI： 10.1002/mus.26385

Source DB:  PubMed          Journal:  Muscle Nerve        ISSN： 0148-639X            Impact factor:   3.217


  42 in total

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