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Article

A Phase 1/2 Study of Flavocoxid, an Oral NF-κB Inhibitor, in Duchenne Muscular Dystrophy

1
Nemo Sud Clinical Centre for Neuromuscular Disorders, Messina University Hospital, Via C. Valeria 1, 98125 Messina, Italy
2
Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy
3
Faculty of Medicine, Mohammed VI University of Health Sciences, Cheikh Khalifa Ibn Zayed Hospital, Bd. Mohammed Taïeb Naciri, Commune Hay Hassani, Casablanca 82 403, Morocco
*
Author to whom correspondence should be addressed.
Senior authors.
Brain Sci. 2021, 11(1), 115; https://doi.org/10.3390/brainsci11010115
Received: 17 December 2020 / Revised: 7 January 2021 / Accepted: 13 January 2021 / Published: 16 January 2021
(This article belongs to the Special Issue Advanced Research in Neuromuscular Disorders)
Flavocoxid is a blended extract containing baicalin and catechin with potent antioxidant and anti-inflammatory properties due to the inhibition of the cyclooxygenase (COX) and 5-lipoxygenase (5-LOX) enzymes, nuclear factor-κB (NF-κB), tumor necrosis factor (TNF)-alpha, and the mitogen-activated protein kinases (MAPKs) pathways. This phase 1/2 study was designed to assess the safety and tolerability of flavocoxid in patients with Duchenne muscular dystrophy (DMD). Thirty-four patients were recruited: 17 were treated with flavocoxid at an oral dose of 250 or 500 mg, according to body weight, for one year; 17 did not receive flavocoxid and served as controls. The treatment was well tolerated and nobody dropped out. Flavocoxid induced a significant reduction in serum interleukin (IL)-1 beta and TNF-alpha only in the group of DMD boys on add-on therapy (flavocoxid added to steroids for at least six months). The decrease in IL-1 beta was higher in younger boys. The serum H2O2 concentrations significantly decreased in patients treated with flavocoxid alone with a secondary reduction of serum glutathione peroxidase (GPx) levels, especially in younger boys. The exploratory outcome measures failed to show significant effects but there was a trend showing that the younger boys who received treatment were faster at performing the Gowers’ maneuver, while the older boys who received treatment were faster at doing the 10-m walk test (10MWT). Therefore, a double-blind, placebo-controlled study for at least two/three years is warranted to verify flavocoxid as a steroid substitute or as add-on therapy to steroids. View Full-Text
Keywords: Duchenne muscular dystrophy; phase 1/2 study; flavocoxid; NF-κB inhibitor; antioxidant; anti-inflammatory agent Duchenne muscular dystrophy; phase 1/2 study; flavocoxid; NF-κB inhibitor; antioxidant; anti-inflammatory agent
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MDPI and ACS Style

Vita, G.L.; Sframeli, M.; Licata, N.; Bitto, A.; Romeo, S.; Frisone, F.; Ciranni, A.; Pallio, G.; Mannino, F.; Aguennouz, M.; Rodolico, C.; Squadrito, F.; Toscano, A.; Messina, S.; Vita, G. A Phase 1/2 Study of Flavocoxid, an Oral NF-κB Inhibitor, in Duchenne Muscular Dystrophy. Brain Sci. 2021, 11, 115. https://doi.org/10.3390/brainsci11010115

AMA Style

Vita GL, Sframeli M, Licata N, Bitto A, Romeo S, Frisone F, Ciranni A, Pallio G, Mannino F, Aguennouz M, Rodolico C, Squadrito F, Toscano A, Messina S, Vita G. A Phase 1/2 Study of Flavocoxid, an Oral NF-κB Inhibitor, in Duchenne Muscular Dystrophy. Brain Sciences. 2021; 11(1):115. https://doi.org/10.3390/brainsci11010115

Chicago/Turabian Style

Vita, Gian L., Maria Sframeli, Norma Licata, Alessandra Bitto, Sara Romeo, Francesca Frisone, Annamaria Ciranni, Giovanni Pallio, Federica Mannino, M’Hammed Aguennouz, Carmelo Rodolico, Francesco Squadrito, Antonio Toscano, Sonia Messina, and Giuseppe Vita. 2021. "A Phase 1/2 Study of Flavocoxid, an Oral NF-κB Inhibitor, in Duchenne Muscular Dystrophy" Brain Sciences 11, no. 1: 115. https://doi.org/10.3390/brainsci11010115

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