Glatiramer acetate has no impact on disease progression in ALS at 40 mg/day: A double- blind, randomized, multicentre, placebo-controlled trial

References

• Bruijn LI, Miller TM, Cleveland DW. Unravelling the mechanisms involved in motor neuron degeneration in ALS. Annu Rev Neurosci. 2004; 27: 723–49
   PubMed Web of Science ®Google Scholar
• Boillée S, van de Velde C, Cleveland DW. ALS: a disease of motor neurons and their non-neuronal neighbours. Neuron. 2006; 52: 39–59
   PubMed Web of Science ®Google Scholar
• Henkel JS, Beers DR, Siklos L, Appel SH. The chemokine MCP-1 and the dendritic and myeloid cells it attracts are increased in the mSOD1 mouse model of ALS. Mol Cell Neurosci. 2006; 31: 427–37
   PubMed Web of Science ®Google Scholar
• Liu B, Hong JS. Role of microglia in inflammation-mediated neurodegenerative diseases: mechanisms and strategies for therapeutic intervention. J Pharmacol Exp Therapeutic. 2003; 304: 1–7
   PubMed Web of Science ®Google Scholar
• Kipnis J, Schwartz M. Controlled autoimmunity in CNS maintenance and repair: naturally occurring CD4+ CD25+ regulatory T-cells at the crossroads of health and disease. Neuromolecular Med. 2005; 7: 197–206
   PubMed Web of Science ®Google Scholar
• Holmøy T. T-cells in amyotrophic lateral sclerosis. Eur J Neurol. 2008; 15: 360–6
   PubMed Web of Science ®Google Scholar
• Farina C, Weber MS, Meinl E, Wekerle H, Hohlfeld R. Glatiramer acetate in multiple sclerosis: update on potential mechanisms of action. Lancet Neurol. 2005; 4: 567–75
   PubMed Web of Science ®Google Scholar
• Weber MS, Starck M, Wagenpfeil S, Meinl E, Hohlfeld R, Farina C. Multiple sclerosis: glatiramer acetate inhibits monocyte reactivity in vitro and in vivo. Brain. 2004; 127: 1370–8
   PubMed Web of Science ®Google Scholar
• Hussien Y, Sanna A, Soderstrom M, Link H, Huang YM. Glatiramer acetate and IFN-β act on dendritic cells in multiple sclerosis. J Neuroimmunol. 2001; 121: 102–10
   PubMed Web of Science ®Google Scholar
• Arnon R, Aharoni R. Neurogenesis and neuroprotection in the CNS: fundamental elements in the effect of glatiramer acetate on treatment of autoimmune neurological disorders. Mol Neurobiol. 2007; 36: 245–53
   PubMed Web of Science ®Google Scholar
• Chen M, Valenzuela RM, Dhib-Jalbut S. Glatiramer acetate-reactive T-cells produce brain derived neurotrophic factor. J Neurol Sci. 2003; 215: 37–44
   PubMed Web of Science ®Google Scholar
• Kerschensteiner M, Stadelmann C, Dechant G, Wekerle H, Hohlfeld R. Neurotrophic cross-talk between the nervous and immune systems: implications for neurological diseases. Ann Neurol. 2003; 53: 292–304
   PubMed Web of Science ®Google Scholar
• Angelov DN, Waibel S, Guntinas-Lichius O, Lenzen M, Neiss WF, Tomov TL, et al. Therapeutic vaccine for acute and chronic motor neuron diseases: implications for amyotrophic lateral sclerosis. Proc Natl Acad Sci U S A. 2003; 100: 4790–5
   PubMed Web of Science ®Google Scholar
• Habisch HJ, Schwalenstöcker B, Danzeisen R, Neuhaus O, Hartung HP, Ludolph A. Limited effects of glatiramer acetate in the high-copy number hSOD1-G93A mouse model of ALS. Exp Neurol. 2007; 206: 288–95
   PubMed Web of Science ®Google Scholar
• Haenggeli C, Julien JP, Mosley RL, Perez N, Dhar A, Gendelman HE, Rothstein JD. Therapeutic immunization with a glatiramer acetate derivative does not alter survival in G93A and G37R-SOD1 mouse models of familial ALS. Neurobiol Dis. 2007; 26: 146–52
   PubMed Web of Science ®Google Scholar
• Ludolph AC, Bendotti C, Blaugrund E, Hengerer B, Löffler JP, Martin J, et al. Guidelines for the preclinical in vivo evaluation of pharmacologically active drugs for ALS/MND: report on the 142nd ENMC International Workshop. Amyotroph Lateral Scler. 2007; 8: 217–23
   PubMedGoogle Scholar
• Gordon PH, Doorish C, Montes J, Mosley RL, Diamond B, Macarthur RB, et al. Randomized, controlled phase II trial of glatiramer acetate in ALS. Neurology. 2006; 66: 1117–9
   PubMed Web of Science ®Google Scholar
• CPMP. Working Party on Efficacy of Medicinal Products. Guideline for Good Clinical Practice. CPMP/ICH/135/95. EMEA. http://www.emea.eu.int/pdfs/human/ich/013595en.pdf.
   Google Scholar
• Slowing the progression of neurodegenerative diseases: Medicinal products (MP) clinical development. London, 2 October 2006. Doc. Ref. EMEA/512562/2006.
   Google Scholar
• Brooks, B. El Escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosis. Subcommittee on Motor Neuron Diseases/Amyotrophic Lateral Sclerosis of the World Federation of Neurology Research Group on Neuromuscular Diseases and the El Escorial ‘Clinical limits of amyotrophic lateral sclerosis’. J Neurol Sci. 1994;124(Suppl):96–107.
   PubMed Web of Science ®Google Scholar
• Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRSR: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999; 169: 13–21
   PubMed Web of Science ®Google Scholar
• Cox DR. Regression models and life-tables. J R Stat Soc [B] 1972; 34: 187–220
   Web of Science ®Google Scholar
• Lanka V, Cudkowicz M. Therapy development for ALS: lessons learned and path forward. Amyotroph Lateral Scler. 2008; 9: 131–40
   PubMed Web of Science ®Google Scholar
• Swash M. Learning from failed trials in ALS. Lancet Neurol. 2007; 6: 1034–5
   PubMed Web of Science ®Google Scholar
• Leigh PN, Meininger V, Bensimon G, Cudkowicz M, Robberecht W. Minocycline for patients with ALS. Lancet Neurol. 2008; 7: 119–20
   PubMed Web of Science ®Google Scholar
• Miller R, Bradley W, Cudkowicz M, Hubble J, Meininger V, Mitsumoto H, et al. Phase II/III randomized trial of TCH346 in patients with ALS. Neurology. 2007; 69: 776–84
   PubMed Web of Science ®Google Scholar
• Barbeito LH, Pehar M, Cassina P, Vargas MR, Peluffo H, Viera L, Estévez AG. A role for astrocytes in motor neuron loss in amyotrophic lateral sclerosis. Brain Res Brain Res Rev. 2004; 47: 263–74
   PubMedGoogle Scholar
• Beckman JS, Boillee S, Yamanaka K, Lobsiger CS, Copeland NG, Jenkins NA, et al. Onset and progression in inherited ALS determined by motor neurons and microglia. Science. 2006; 312: 1389–92
   PubMed Web of Science ®Google Scholar
• Zhang R, Gascon R, Miller RG, Gelinas DF, Mass J, Hadlock K, et al. Evidence for systemic immune system alterations in sporadic amyotrophic lateral sclerosis (SALS). J Neuroimmunol. 2005; 159: 215–24
   PubMed Web of Science ®Google Scholar
• Zhao W, Xiao Q, Henkel JS, Beers DR, Simpson EP, Yen AA, et al. Activated microglia in ALS: a double-edged sword. Amyotroph Lateral Scler. 2005; 6(Suppl 1)27–9
   Google Scholar
• Schoenfeld DA, Cudkowicz M. Design of phase II ALS clinical trials. Amyotroph Lateral Scler. 2008; 9: 16–23
   PubMed Web of Science ®Google Scholar