DiaPep277 peptide therapy in the context of other immune intervention trials in type 1 diabetes

Expert Opinion on Biological Therapy

Volumn 11, Issue 9, 2011, Pages 1233-1240

  Tuccinardi, Dario ^a   Fioriti, Elvira ^a   Manfrini, Silvia ^a   D'Amico, Eugenio ^b   Pozzilli, Paolo ^a,c  

^a UNIVERSITY CAMPUS BIO MEDICO   (Italy)

^b Azienda Ospedaliera di Cosenza   (Italy)

^c QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

DiaPep277; Immunomodulation; Type 1 diabetes

Indexed keywords

ABATACEPT; ANTIDIABETIC AGENT; DACLIZUMAB; DIAPEP277; EPITOPE; GLUTAMATE DECARBOXYLASE; GLUTAMATE DECARBOXYLASE 65; GLUTAMATE DECARBOXYLASE 67; HEAT SHOCK PROTEIN 60; HEMOGLOBIN A1C; INSULIN; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; MONOCLONAL ANTIBODY CD3; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; NBI 6024; OTELIXIZUMAB; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; TEPLIZUMAB; UNCLASSIFIED DRUG; VALYLLEUCYLGLYCYLGLYCYLGLYCYLVALYLALANYLLEUCYLLEUCYLARGINYLVALYLISOLEUCYLPROLYLA LANYLLEUCYLASPARTYLSERYLLEUCYLTHREONYLPROLYLALANYLASPARAGINYLGLUTAMYLASPARTIC ACID; ZENAPAXAN;

AUTOIMMUNE DISEASE; CELL FUNCTION; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; IMMUNOMODULATION; INJECTION SITE DISCOMFORT; INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS ISLET BETA CELL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; REVIEW; SYSTEMATIC REVIEW; SYSTEMIC DISEASE;

ANIMALS; CHAPERONIN 60; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 1; HUMANS; INSULIN-SECRETING CELLS; PEPTIDE FRAGMENTS;

EID: 80051503029     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2011.599319     Document Type: Review

References (41)

1. Yoon JW, Jun HS. Autoimmune destruction of pancreatic beta cells. Am J Ther 2005;12:580-91
2. Roep BO. The role of T-cells in the pathogenesis of type 1 diabetes: from cause to cure. Diabetologia 2003;46:305-21 (Pubitemid 36547585)
3. Csorba TR, Lyon AW, Hollenberg MD. Autoimmunity and the pathogenesis of type 1 diabetes. Crit Rev Clin Lab Sci 2010;47:51-71
4. Zehn D, Bevan MJ. T cells with low avidity for a tissue restricted antigen routinely evade central and peripheral tolerance and cause autoimmunity. Immunity 2006;25:261-70 (Pubitemid 44224142)
5. Steffes MW, Sibley S, Jackson M, Thomas W. beta-cell function and the development of diabetes-related complications in the diabetes control and complications trial. Diabetes Care 2003;26:832-6 (Pubitemid 36929351)
6. Bekris LM, Kavanagh TJ, Lernmark A. Targeting type 1 diabetes before and at the clinical onset of disease. Endocr Metabol Immune Disord Drug Targets 2006;6:103-24 (Pubitemid 43796715)
7. Roep BO, Atkinson M. Animal models have little to teach us about type 1 diabetes: 1. In support of this proposal. Diabetologia 2004;47:1650-6 (Pubitemid 40022396)
8. Goudy KS, Tish R. Immunotherapy for the prevention and treatment of type 1 diabetes. Int Rev Immunol 2005;24:307-26 (Pubitemid 41755150)
9. Keymeulen B, Vandemeulebroucke E, Ziegler AG, et al. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med 2005;352:2598-608 (Pubitemid 41007846)
10. Bisikirska BC, Herold KC. Use of anti-CD3 monoclonal antibody to induce immune regulation in type 1 diabetes. Ann NY Acad Sci 2004;1037:1-9 (Pubitemid 40299735)
11. Herold KC, Hagopian W, Auger JA, et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med 2002;346:1692-8 (Pubitemid 34547482)
12. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk" ClinicalTrials.gov NCT01030861. Available from: http://clinicaltrials.gov/ct2/ show/NCT01030861? term=NCT01030861&rank=1
13. Tolerx, Inc. Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1. ClinicalTrials.gov NCT00678886. Available from: http://clinicaltrials.gov/ct2/show/NCT00678886?term= NCT00678886&rank=1
14. Knip M, Korhonen S, Kulmala P, et al. Prediction of type 1 diabetes in the general population. Diabetes Care 2010;33:1206-12
15. Tisch R, Liblau RS, Yang XD, et al. Induction of GAD65-specific regulatory T cells inhibits ongoing autoimmune diabetes in nonobese diabetic mice. Diabetes 1998;47:894-9 (Pubitemid 28255662)
16. Ludvigsson J, Faresjo M, Hjorth M, et al. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med 2008;359:1909-20
17. Larsen CM, Faulenbach M, Vaag A, et al. Interleukin-1-receptor antagonist in type 2 diabetes mellitus. N Engl J Med 2007;356:1517-26 (Pubitemid 46588416)
18. Mandrup-Poulsen T. The role of interleukin-1 in the pathogenesis of IDDM. Diabetologia 1996;39:1005-29 (Pubitemid 26275930)
19. Alleva DG, Gaur A, Jin L, et al. Immunological characterization and therapeutic activity of an altered-peptide ligand, NBI-6024, based on the immunodominant type 1 diabetes autoantigen insulin B-chain (9-23) peptide. Diabetes 2002;51:2126-34 (Pubitemid 34729017)
20. Walter M, Philotheou A, Bonnici F, et al. No effect of the altered peptide ligand NBI-6024 on beta-cell residual function and insulin needs in new-onset type 1 diabetes. Diabetes Care 2009;32:2036-40
21. Raskin P, Mohan A. Emerging treatments for the prevention of type 1 diabetes. Expert Opin Emerg Drugs 2010;15:225-36
22. Masharani UB, Becker J. Teplizumab therapy for type 1 diabetes. Expert Opin Biol Ther 2010;10:459-65
23. Herold KC, Gitelman S, Greenbaum C, et al. Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years. Clin Immunol 2009;132:166-73
24. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Intravenous CTLA4-lg treatment in recent onset type 1 diabetes mellitus. ClinicalTrials.gov NCT00505375. Available from: http://clinicaltrial.gov/ct2/ show/NCT00505375
25. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Effect of metabolic control at onset of diabetes on Progression of Type 1 Diabetes. ClinicalTrials.gov NCT00505206. Available from: http://clinicaltrial. gov/ct2/show/NCT00505206
26. Pescovitz MD, Greenbaum CJ, Krause-Steinrauf H, et al. Rituximab, B-lymphocyte depletion, and preservation of beta-cell function. N Engl J Med 2009;361:2143-52
27. Gottlieb PA, Quinlan S, Krause-Steinrauf H, et al. Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new-onset type 1 diabetes. Diabetes Care 2010;33:826-32
28. Raz I, Elias D, Avron A, et al. beta-cell function in new-onset type 1 diabetes and immunomodulation with a heat-shock protein peptide (DiaPep277): a randomised, double-blind, phase II trial. Lancet 2001;358:1749-53 (Pubitemid 33152998)
29. Eldor R, Kassem S, Raz I. Immune modulation in type 1 diabetes mellitus using DiaPep277: a short review and update of recent clinical trial results. Diabetes Metab Res Rev 2009;25:316-20
30. Quintana FJ, Cohen IR. Regulatory T cells and immune computation. Eur J Immunol 2008;38:903-7
31. Cohen-Sfady M, Nussbaum G, Pevsner-Fischer M, et al. Heat shock protein 60 activates B cells via the TLR4-MyD88 pathway. J Immunol 2005;175:3594-602 (Pubitemid 41292018)
32. Fischer B, Elias D, Bretzel RG, Linn T. Immunomodulation with heat shock protein DiaPep277 to preserve beta cell function in type 1 diabetes-an update. Expert Opin Biol Ther 2010;10:265-72
33. Elias D, Cohen IR. Peptide therapy for diabetes in NOD mice. Lancet 1994;343:704-6 (Pubitemid 24087851)
34. Elias D, Reshef T, Birk OS, et al. Vaccination against autoimmune mouse diabetes with a T-cell epitope of the human 65-kDa heat shock protein. Proc Natl Acad Sci USA 1991;88:3088-91 (Pubitemid 21916564)
35. Zanin-Zhorov A, Cahalon L, Tal G, et al. Heat shock protein 60 enhances CD4+ CD25+ regulatory T cell function via innate TLR2 signaling. J Clin Invest 2006;116:2022-32 (Pubitemid 44033326)
36. Raz I, Avron A, Tamir M, et al. Treatment of new-onset type 1 diabetes with peptide DiaPep277 is safe and associated with preserved beta-cell function: extension of a randomized, double-blind, Phase II trial. Diabetes Metab Res Rev 2007;23:292-8 (Pubitemid 46851470)
37. Schloot NC, Meierhoff G, Lengyel C, et al. Effect of heat shock protein peptide DiaPep277 on beta-cell function in paediatric and adult patients with recent-onset diabetes mellitus type 1: two prospective, randomized, double-blind phase II trials. Diabetes Metab Res Rev 2007;23:276-85 (Pubitemid 46851468)
38. Petrone A, Spoletini M, Zampetti S, et al.Immunotherapy Diabetes (IMDIAB) Group. The PTPN22 1858T gene variant in type 1 diabetes is associated with reduced residual beta-cell function and worse metabolic control. Diabetes Care 2008;31:1214-18
39. Bizzarri C, Pitocco D, Napoli N, et al. Metabolic and immune parameters at clinical onset of insulin-dependent diabetes: a population-based study. IMDIAB Study Group. Immunother Diabetes Metab 1998;47:1205-10
40. Jin L, Zhu A, Wang Y, et al. A Th1-recognized peptide P277, when tandemly repeated, enhances a Th2 immune response toward effective vaccines against autoimmune diabetes in nonobese diabetic mice. J Immunol 2008;180:58-63
41. Reimann M, Bonifacio E, Solimena M, et al. An update on preventive and regenerative therapies in diabetes mellitus. Pharmacol Ther 2009;121:317-31