Anergen Inc. has recently demonstrated in a Phase IIa clinical trial in rheumatoid arthritis preliminary validation of a generic concept that MHC analog peptides can be used to vaccinate against MHC-linked autoimmune diseases (1). Using this same concept, they have shown (Figure 4) that a cyclicized peptide from the murine MHC class II Iag7 third hypervariable region of the beta chain induces allele specific anti-self MHC antibodies and prevents development of spontaneous insulin dependent diabetes (IDD) in the non-obese-diabetic (NOD) mouse. The current Phase I grant proposes a pre-clinical feasibility study to determine whether the same vaccine is effective at modulating the autoreactive T cells and extend disease progression in late stage islet tissue destruction, or so-called honey- moon period in pre-diabetic NOD mice. These studies will provide critical pre-clinical data necessary to obtain regulatory approval to test efficacy of a human equivalent of this vaccine in newly diagnosed """"""""honey-moon"""""""" diabetic individuals. The subsequent Phase II proposal for the project will focus on development of the human equivalent of this vaccine, evaluating the pre-IND safety profile of such a product, and definition of a commercializable process for reproducible manufacturing of the human vaccine.
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