Importance of the field: Type 1 diabetes is a chronic autoimmune disease in which pancreatic beta cells are selectively destroyed. Ultimately hyperglycemia develops and insulin substitution becomes necessary. Immunomodulation aims at arresting this autoimmune attack. DiaPep277, the major T-cell epitope of heat shock protein 60 (hsp60), has been shown to be effective as a modulator of the immune system in type 1 diabetes and is the focus of this review.
Areas covered in this review: A literature search of Pubmed listed publications covering 1990 - 2009 and a website search of the licensing company were performed.
What the reader will gain: DiaPep277 has been successfully employed in animal models and has been investigated in Phase I - III studies in humans. A combined analysis of the Phase II trials showed a significant preservation of beta cell function in adults without adverse effects, but HbA1c was not changed. A Phase III clinical trial is ongoing, and a second Phase III trial will start in early 2010. Addressing the underlying autoimmune process is the call of the future in type 1 diabetes.
Take home message: Use of Diapep277 is a promising therapeutic strategy currently being tested in Phase III trials.