Results of a phase IIa clinical trial of an anti-inflammatory molecule, chaperonin 10, in multiple sclerosis

Multiple Sclerosis

Volumn 15, Issue 3, 2009, Pages 329-336

  Broadley, Simon A ^a,b   Vanags, D ^c   Williams, B ^c   Johnson, B ^c   Feeney, D ^c   Griffiths, L ^a   Shakib, S ^d   Brown, G ^d   Coulthard, A ^e,f   Mullins, P ^g   Kneebone, C ^d  

^a GRIFFITH UNIVERSITY   (Australia)

^b GOLD COAST UNIVERSITY HOSPITAL   (Australia)

^c CBio Ltd   (Australia)

^d ROYAL ADELAIDE HOSPITAL   (Australia)

^e ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^f UNIVERSITY OF QUEENSLAND   (Australia)

^g UNIVERSITY OF AUCKLAND   (New Zealand)

Author keywords

Chaperonin 10; Clinical trial; Heat shock proteins; Multiple sclerosis 41 ; Randomized controlled (CONSORT agreement); Treatment

Indexed keywords

CHAPERONIN; GADOLINIUM; INTERLEUKIN 10; INTERLEUKIN 12; INTERLEUKIN 1BETA; INTERLEUKIN 6; INTERLEUKIN 8; LIPOPOLYSACCHARIDE; PLACEBO; PROTEIN ANTIBODY; RECOMBINANT CHAPERONIN 10; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ADULT; ANTIBODY TITER; ARTICLE; BLOOD DISEASE; BRAIN DISEASE; BREAST DISEASE; CLINICAL ASSESSMENT TOOL; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOKINE RELEASE; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EX VIVO STUDY; EXPANDED DISABILITY STATUS SCALE; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; GENITAL SYSTEM DISEASE; HUMAN; INFECTION; INFESTATION; KIDNEY DISEASE; LETHARGY; LEUKOCYTE; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; METABOLIC DISORDER; MONONUCLEAR CELL; MULTIPLE SCLEROSIS; MULTIPLE SCLEROSIS IMPACT SCALE 29; MUSCULOSKELETAL DISEASE; NUCLEAR MAGNETIC RESONANCE IMAGING; NUTRITIONAL DISORDER; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; RESPIRATORY TRACT DISEASE; SKIN DISEASE; SYSTEMIC DISEASE; THORAX DISEASE; URINARY DYSFUNCTION; VASCULAR DISEASE;

ADULT; ANTI-INFLAMMATORY AGENTS; CHAPERONIN 10; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; RECURRENCE; TREATMENT OUTCOME;

EID: 61849150375     PISSN: 13524585     EISSN: None     Source Type: Journal    
DOI: 10.1177/1352458508099141     Document Type: Article

References (26)

1. Compston, A, Coles, A. Multiple sclerosis. Lancet 2002; 359: 1221-1231.
2. Barnett, MH, Prineas, JW. Relapsing and remitting multiple sclerosis: pathology of the newly forming lesion. Ann Neurol 2004; 55: 458-468.
3. Massacesi, L, Parigi, A, Barilaro, A, et al. Efficacy of azathioprine on multiple sclerosis new brain lesions evaluated using magnetic resonance imaging. Arch Neurol 2005; 62: 1843-1847.
4. Hartung, HP, Gonsette, R, Konig, N, et al. Mitoxantrone in progressive multiple sclerosis: A placebo-controlled, double-blind, randomised, multicentre trial. Lancet 2002; 360: 2018-2025.
5. Johnson, KP, Brooks, BR, Cohen, JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995; 45: 1268-1276.
6. Jacobs, LD, Cookfair, DL, Rudick, RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol 1996; 39: 285-294.
7. Beck, RW, Cleary, PA, Anderson Jr, MM, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med 1992; 326: 581-588.
8. Polman, CH, O'Connor, PW, Havrdova, E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006; 354: 899-910.
9. Harness, J, Cavanagh, A, Morton, H, McCombe, P. A protective effect of early pregnancy factor on experimental autoimmune encephalomyelitis induced in Lewis rats by inoculation with myelin basic protein. J Neurol Sci 2003; 216: 33-41.
10. Zhang, B, Harness, J, Somodevilla-Torres, MJ, et al. Early pregnancy factor suppresses experimental autoimmune encephalomyelitis induced in Lewis rats with myelin basic protein and in SJL/J mice with myelin proteolipid protein peptide 139-151. J Neurol Sci 2000; 182: 5-15.
11. Mehta, AR, Eessalu, TE. Aggarwal BB purification and characterization of early pregnancy factor from human pregnancy sera. J Biol Chem 1989; 264: 2266-2271.
12. Ohashi, K, Burkart, V, Flohe, S, Kolb, H. Cutting edge: Heat shock protein 60 is a putative endogenous ligand of the toll-like receptor-4 complex. J Immunol 2000; 164: 558-561.
13. Vabulas, RM, Ahmad-Nejad, P, da Costa, C, et al. Endocytosed HSP60s use toll-like receptor 2 (TLR2) and TLR4 to activate the toll/interleukin-1 receptor signaling pathway in innate immune cells. J Biol Chem 2001; 276: 31332-31339.
14. Johnson, BJ, Le, TT, Dobbin, CA, et al. Heat shock protein 10 inhibits lipopolysaccharide-induced inflammatory mediator production. J Biol Chem 2005; 280: 4037-4047.
15. Zhang, B, Walsh, MD, Nguyen, KB, et al. Early pregnancy factor treatment suppresses the inflammatory response and adhesion molecule expression in the spinal cord of SJL/J mice with experimental autoimmune encephalomyelitis and the delayed-type hypersensitivity reaction to trinitrochlorobenzene in normal BALB/c mice. J Neurol Sci 2003; 212: 37-46.
16. Athanasas-Platsis, S, Zhang, B, Hillyard, NC, et al. Early pregnancy factor suppresses the infiltration of lymphocytes and macrophages in the spinal cord of rats during experimental autoimmune encephalomyelitis but has no effect on apoptosis. J Neurol Sci 2003; 214: 27-36.
17. McCombe, PA. Recombinant EPF/chaperonin 10 promotes the survival of O4-positive pro-oligodendrocytes prepared from neonatal rat brain. Cell Stress Chaperones 2008; 13: 467-474.
18. Broadley, SA, Johnson, B, Feeney, D, Shakib, S. Phase 1a and 1b clinical trials of chaperonin 10 in healthy volunteers and patients with multiple sclerosis. J Neurol Sci 2005; 238: S223.
19. McDonald, WI, Compston, A, Edan, G, et al. Recommended diagnostic criteria for multiple sclerosis: Guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol 2001; 50: 121-127.
20. Paty, DW, Oger, JJ, Kastrukoff, LF, et al. MRI in the diagnosis of MS: A prospective study with comparison of clinical evaluation, evoked potentials, oligoclonal banding, and CT. Neurology 1988; 38: 180-185.
21. Kurtzke, JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983; 33: 1444-1452.
22. Hobart, J, Lamping, D, Fitzpatrick, R, Riazi, A, Thompson, A. The Multiple Sclerosis Impact Scale (MSIS-29): A new patient-based outcome measure. Brain 2001; 124: 962-973.
23. Vanags, D, Williams, B, Johnson, B, et al. Therapeutic efficacy and safety of chaperonin 10 in patients with rheumatoid arthritis: A double-blind randomised trial. Lancet 2006; 368: 855-863.
24. Tasker, SA, Treanor, JJ, Paxton, WB, Wallace, MR. Efficacy of influenza vaccination in HIV-infected persons. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1999; 131: 430-433.
25. Williams, B, Vanags, D, Hall, S, et al. Efficacy and safety of chaperonin 10 in patients with moderate to severe plaque psoriasis: evidence of utility beyond a single indication. Arch Dermatol 2008; 144: 683-685.
26. PRISMS. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet 1998; 352: 1498-1504.