ILB® attenuates clinical symptoms and serum biomarkers of oxidative/nitrosative stress and mitochondrial dysfunction in patients with Amyotrophic Lateral Sclerosis

Giacomo Lazzarino, Renata Mangione, Antonio Belli, Valentina Di Pietro, Zsuzsanna Nagy, Nicholas M. Barnes, Lars Bruce, Bernardo M. Ropero, Lennart I. Persson, Benedetta Manca, Miriam Wissam Saab, Angela M. Amorini, Barbara Tavazzi, Giuseppe Lazzarino, Ann Logan

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Abstract

Oxidative/nitrosative stress and mitochondrial dysfunction is a hallmark of amyotrophic lateral sclerosis (ALS), an invariably fatal progressive neurodegenerative disease. Here, as an exploratory arm of a phase II clinical trial (EudraCT Number 2017-005065-47), we used high performance liquid chromatography(HPLC) to investigate changes in the metabolic profiles of serum from ALS patients treated weekly for 4 weeks with a repeated sub-cutaneous dose of 1 mg/kg of a proprietary low molecular weight dextran sulphate, called ILB®. A significant normalization of the serum levels of several key metabolites was observed over the treatment period, including N-acetylaspartate (NAA), oxypurines, biomarkers of oxidative/nitrosative stress and antioxidants. An improved serum metabolic profile was accompanied by significant amelioration of the patients’ clinical conditions, indicating a response to ILB® treatment that appears to be mediated by improvement of tissue bioenergetics, decrease of oxidative/nitrosative stress and attenuation of (neuro)inflammatory processes.
Original languageEnglish
Article number794
Number of pages15
JournalJournal of Personalized Medicine
Volume11
Issue number8
DOIs
Publication statusPublished - 14 Aug 2021

Bibliographical note

Funding Information:
This research was funded by Tikomed AB, who had no influence on the conduct of the trial and was not involved in data collection or analysis.

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Keywords

  • Amino acids
  • Amyotrophic lateral sclerosis
  • Antioxidants
  • Energy metabolism
  • HPLC
  • Low molecular weight-dextran sulphate
  • Mitochondrial dysfunction
  • N-acetylaspartate
  • Oxidative/nitrosative stress
  • Serum biomarkers

ASJC Scopus subject areas

  • Medicine (miscellaneous)

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