title: DiaPep277 peptide therapy in the context of other immune intervention trials in type 1 diabetes.
abstract: BACKGROUND
  Type 1 diabetes (T1D) is characterized by the autoimmune destruction of pancreatic β-cells. The aim of immune intervention is to arrest this autoimmune attack. DiaPep277, a major T-cell epitope of heat shock protein 60 (hsp60), has been shown to be effective in the modulation of the immune response in recent onset T1D and is the main focus of this review in the context of other ongoing trials using different approaches.
  
  
  METHODS
  The authors performed a literature search of Pubmed listed publications (from the last 10 years) and a website search of the company licensing DiaPep277. DiaPep277 has been investigated in Phase I - III trials in humans. Phase II trials showed a significant preservation of β-cell function in adult T1D patients (but not children) with an absence of adverse effects and not accompanied by lower glycosylated haemoglobin (HbA1c) levels or reduced daily insulin requirement compared with placebo-treated patients.
  
  
  CONCLUSIONS
  Administration of DiaPep277 is safe and represents a promising therapeutic strategy in patients with recent-onset T1D. The results of two large Phase III trials will tell us whether this therapy may change our current approach to treating T1D patients at diagnosis.
authors.affiliation: University Campus Bio-Medico, Via Álvaro del Portillo, 21 - 00128, Rome, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Tuccinardi
authors.forename: Elvira
authors.initials: E
authors.lastname: Fioriti
authors.forename: Silvia
authors.initials: S
authors.lastname: Manfrini
authors.forename: Eugenio
authors.initials: E
authors.lastname: D'Amico
authors.forename: Paolo
authors.initials: P
authors.lastname: Pozzilli
mesh_terms: D000818:Animals; D018834:Chaperonin 60 / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000276:immunology*; D006801:Humans; D050417:Insulin-Secreting Cells / Q000187:drug effects*; D010446:Peptide Fragments / Q000627:therapeutic use*
chemical_list: D018834:Chaperonin 60; C447781:DiaPep 277; D010446:Peptide Fragments