التفاصيل البيبلوغرافية
| العنوان: |
Immunomodulation in Type 1 Diabetes by NBI-6024, an Altered Peptide Ligand of the Insulin B(9−23) Epitope. |
| المؤلفون: |
Alleva, D. G., Maki, R. A., Putnam, A. L., Robinson, J. M., Kipnes, M. S., Dandona, P., Marks, J. B., Simmons, D. L., Greenbaum, C. J., Jimenez, R. G., Conlon, P. J., Gottlieb, P. A. |
| المصدر: |
Scandinavian Journal of Immunology; Jan2006, Vol. 63 Issue 1, p59-69, 11p, 3 Charts, 4 Graphs |
| مصطلحات موضوعية: |
IMMUNOREGULATION, DIABETES, LIGANDS (Biochemistry), AMINO acids, INSULIN, PEOPLE with diabetes, LYMPHOCYTES, CLINICAL trials |
| مستخلص: |
NBI-6024 is an altered peptide ligand (APL) corresponding to the 9–23 amino acid region of the insulin B chain (B(9−23)), an epitope recognized by inflammatory interferon-γ-producing T helper (Th)1 lymphocytes in type 1 diabetic patients. Immunomodulatory effects of NBI-6024 administration in recent-onset diabetic patients in a phase I clinical trial (NBI-6024-0003) were measured in peripheral blood mononuclear cells using the enzyme-linked immunosorbent spot assay. Analysis of the mean magnitude of cytokine responses to B(9−23) and NBI-6024 for each cohort showed significant increases in interleukin-5 responses (a Th2 regulatory phenotype) in cohorts that received APL relative to those receiving placebo. A responder analysis showed that Th1 responses to B(9−23) and NBI-6024 were observed almost exclusively in the placebo-treated diabetic population but not in nondiabetic control subjects and that APL administration (five biweekly subcutaneous injections) significantly and dose-dependently reduced the percentage of patients with these Th1 responses. The results of this phase I clinical study strongly suggest that NBI-6024 treatment shifted the Th1 pathogenic responses in recent-onset type 1 diabetic patients to a protective Th2 regulatory phenotype. The significance of these findings on the clinical outcome of disease is currently under investigation in a phase II multidose study. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
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