Elias Dana, Avron Ann, Tamir Merana, Raz Itamar
DeveloGen Israel Ltd., Kiryat Weizmann, Rehovot 76326, Israel.
Ann N Y Acad Sci. 2006 Oct;1079:340-4. doi: 10.1196/annals.1375.052.
DiaPep277 is an immunomodulatory peptide that arrests beta cell destruction in mouse models of type 1 diabetes mellitus (T1DM). This article extends an original pilot observation to two studies of 61 patients (age > 16 years), diagnosed with T1DM within 6 months, and with measurable beta cell function. Patients were treated with placebo (n = 27) or 1.0 mg DiaPep277 (n = 34). After 13 months, 1.0 mg Dia Pep277 treatment significantly (P = 0.02) preserved beta cell function as compared to the control with a trend for reduced HbA1c. This was achieved without an increase in insulin dose in the DiaPep277 group and with excellent safety. DiaPep277-treated patients also had fewer Th1 DiaPep277-specific T cells.
DiaPep277是一种免疫调节肽,可阻止1型糖尿病(T1DM)小鼠模型中的β细胞破坏。本文将一项初步观察结果扩展至两项针对61例患者(年龄>16岁)的研究,这些患者在6个月内被诊断为T1DM,且具有可测量的β细胞功能。患者接受安慰剂治疗(n = 27)或1.0 mg DiaPep277治疗(n = 34)。13个月后,与对照组相比,1.0 mg Dia Pep277治疗显著(P = 0.02)保留了β细胞功能,且糖化血红蛋白(HbA1c)有降低趋势。在DiaPep277组中,这一结果是在未增加胰岛素剂量的情况下实现的,并且安全性良好。接受DiaPep277治疗的患者中,Th1 DiaPep277特异性T细胞也较少。