University Campus Bio-Medico, Via Álvaro del Portillo, 21 - 00128, Rome, Italy.
Expert Opin Biol Ther. 2011 Sep;11(9):1233-40. doi: 10.1517/14712598.2011.599319. Epub 2011 Jul 13.
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.
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.
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.
1 型糖尿病（T1D）的特征是胰岛β细胞的自身免疫破坏。免疫干预的目的是阻止这种自身免疫攻击。DiaPep277 是热休克蛋白 60（hsp60）的主要 T 细胞表位，最近在新诊断的 T1D 中显示出对免疫反应的调节作用，并且是本综述的主要重点，同时还介绍了其他正在使用不同方法进行的试验。
作者对 Pubmed 列出的出版物（过去 10 年）进行了文献检索，并对 DiaPep277 的许可公司进行了网站搜索。DiaPep277 已在人体进行了 I 期-III 期试验。II 期试验显示，在成年 T1D 患者（而非儿童）中，β细胞功能得到显著保留，无不良反应，与安慰剂治疗患者相比，糖化血红蛋白（HbA1c）水平或每日胰岛素需求没有降低。
DiaPep277 的给药是安全的，代表了一种有前途的治疗新诊断的 T1D 患者的策略。两项大型 III 期试验的结果将告诉我们，这种治疗方法是否可能改变我们目前对 T1D 患者的治疗方法。
