Lunasin does not slow ALS progression: results of an open-label, single-center, hybrid-virtual 12-month trial

References

• Liu J, Jia S, Kirberger M, Chen N. Lunasin as a promising health-beneficial peptide. Eur Rev Med Pharmacol Sci. 2014;18:2070–5.
   PubMed Web of Science ®Google Scholar
• Hernandez-Ledesma B, Hsieh CC, de Lumen B. Relationship between lunasin’s sequence and its inhibitory activity of histones H3 and H4 acetylation. Mol Nutr Food Res. 2011;55:989–98.
   PubMed Web of Science ®Google Scholar
• Shidal C, Inaba J, Yaddanapudi K, Davis KR. The soy-derived peptide lunasin inhibits invasive potential of melanoma initiating cells. Oncotarget. 2017;8:25525–41.
   PubMedGoogle Scholar
• Galvez A, Chen N, Macasieb J, de Lumen B. Chemopreventive property of a soybean peptide (lunasin) that binds to deacetylated histones and inhibits acetylation. Cancer Res. 2001;61:7473–8.
   PubMed Web of Science ®Google Scholar
• Jeong J, Jeong J, Park J, Lee S, Lee J, Lee H, et al. Cancer-preventive peptide lunasin from Solanum nigrum L. inhibits acetylation of core histones H3 and H4 and phosphorylation of retinoblastoma protein (Rb). J Agric Food Chem. 2007;55:10707–13.
   PubMed Web of Science ®Google Scholar
• Cudkowicz M, Andres P, Macdonald S, Bedlack R, Choudry R, Brown R, et al. Phase 2 study of sodium phenylbutyrate in ALS. Amyotroph Lateral Scler. 2009;10:99–106.
   PubMed Web of Science ®Google Scholar
• Jimenez-Pacheco A, Franco J, Lopez S, Gomez-Zumaquero J, Magdalena Leal-Lesarte M, Caballero-Hernandez D, et al. Epigenetic mechanisms of gene regulation in amyotrophic lateral sclerosis. Adv Exp Med Biol. 2017;978:255–75.
   PubMed Web of Science ®Google Scholar
• Piepers S, Veldink JH, de Jong SW, van der Tweel I, van der Pol W, Uijtendaal E, et al. Randomized sequential trial of valproic acid in amyotrophic lateral sclerosis. Ann Neurol. 2009;66:227–34.
   PubMed Web of Science ®Google Scholar
• https://www.youtube.com/watch?v=2U16BK61xic. Accessed February 17, 2018. (Archived by WebCite® at http://www.webcitation.org/6xIlvJt4h)
   Google Scholar
• ALSUntangled G. ALSUntangled no. 26: lunasin. Amyotroph Lateral Scler Frontotemporal Degener. 2014;7:622–6.
   Google Scholar
• Bedlack R, Wicks P, Heywood J, Kasarskis E. Modifiable barriers to enrollment in American ALS research studies. Amyotroph Lateral Scler. 2010;11:502–7.
   PubMed Web of Science ®Google Scholar
• http://www.alsreversals.com/roar.html. Accessed February 17, 2018. (Archived by WebCite® at http://www.webcitation.org/6xImfmwwr).
   Google Scholar
• Wasner M, Klier H, Borasio G. The use of alternative medicine by patients with amyotrophic lateral sclerosis. J Neurol Sci. 2001;191:151–4.
   PubMed Web of Science ®Google Scholar
• Wicks P, Vaughan T, Massagli M, Heywood J. Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm. Nat Biotechnol. 2011;29:411–4.
   PubMed Web of Science ®Google Scholar
• https://reliv.com/p/lunarich-x. Accessed February 26, 2018. (Archived by WebCite® at http://www.webcitation.org/6xWmACyCc).
   Google Scholar
• https://reliv.com/p/provantage. Accessed February 26, 2018. (Archived by WebCite® at http://www.webcitation.org/6xWmb0a6l).
   Google Scholar
• https://reliv.com/p/reliv-now. Accessed February 26, 2018. (Archived by WebCite® at http://www.webcitation.org/6xWmqMMBZ).
   Google Scholar
• Bedlack R, Vaughan T, Wicks P, Heywood J, Sinani E, Selsov R, et al. How common are ALS plateaus and reversals? Neurology. 2016;86:808–12.
   PubMed Web of Science ®Google Scholar
• Sadri-Vakili G, Bouzou B, Benn C, Kim M, Chawla P, Overland R, et al. Histones associated with downregulated genes are hypo-acetylated in Huntington’s disease models. Hum Mol Genet. 2007;16:1293–306.
   PubMed Web of Science ®Google Scholar
• Kim MO, Chawla P, Overland RP, Xia E, Sadri-Vakili G, Cha JHJ. Altered histone monoubiquination mediated by mutant huntington induces transcriptional dysregulation. J Neurosci. 2008;28:3947–57.
   PubMed Web of Science ®Google Scholar
• McFarland KN, Das S, Sun TT, Leyfer D, Xia E, Sangrey GR, et al. Genome-wide histone acetylation is altered in a transgenic mouse model of Huntington’s disease. PLoS One. 2012;7:e41423.
   PubMed Web of Science ®Google Scholar
• Bedlack R, Pastula D, Welsh E, Pulley D, Cudkowicz M. Scrutinizing enrollment in ALS clinical trials: room for improvement? Amyotroph Lateral Scler. 2008;9:257–65.
   PubMed Web of Science ®Google Scholar
• Atassi N, Yerramilli-Rao P, Szymonifka J, Yu H, Kearney M, Grasso D, et al. Analysis of start-up, retention, and adherence in ALS clinical trials. Neurology. 2013;81:1350–5.
   PubMed Web of Science ®Google Scholar
• Lin L. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255–68.
   PubMed Web of Science ®Google Scholar
• Harrison D, Mehta P, van Es MA, Stommel E, Drory VE, Nefussy B, et al. ALS reversals: demographics, disease characteristics, treatments and co-morbidities. Amyotroph Lateral Scler Frontotemporal Degener. 2018;1–5. [Epub ahead of print].
   PubMed Web of Science ®Google Scholar
• Chio A, Canosa A, Gallo S, Cammarosano S, Moglia C, Fuda G, et al. ALS clinical trials: do enrolled patients accurately represent the ALS population? Neurology. 2011;77:1432–7.
   PubMed Web of Science ®Google Scholar
• Atassi N, Berry J, Shui A, Zach N, Sherman A, Sinani E, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology. 2014;83:1719–25.
   PubMed Web of Science ®Google Scholar
• Rabourn J, Bedlack R. SAPs: a different perspective. Am J Bioeth. 2014;14:19–20.
   PubMed Web of Science ®Google Scholar
• Wicks P, Heywood J. Data donation could power the learning health care system, including special access programs. Am J Bioeth. 2014;14:27–9.
   PubMed Web of Science ®Google Scholar
• Wicks P, Heywood J. Getting stem cell patients ‘on the grid’. Nat Biotechnol. 2016;34:1228–30.
   PubMed Web of Science ®Google Scholar
• Beydoun S, Rosenfeld J. Edaravone in amyotrophic lateral sclerosis-lessons from the clinical development program. US Neurol. 2018;14:47–53.
   Google Scholar
• Mitsumoto H. Guidelines for ALS clinical trials (AIRLIE HOUSE 2016) and clinical criteria (the diagnosis WFN research group 2015-a critical appraisal). J Neurol Sci. 2017;381:39.
   PubMed Web of Science ®Google Scholar