Abstract: This invention provides methods of treating insulin-dependent diabetes mellitus in a subject comprising administering to the subject a self-vector encoding human proinsulin. The invention also provides a pharmaceutical composition comprising a self-vector encoding human proinsulin, as well as treatment and maintenance regimens for administering the pharmaceutical composition to a subject.

Abstract: Disclosed are improved methods for the treatment or prevention of an autoimmune disease comprising administration of a modified self-vector encoding and capable of expressing a self-polypeptide that includes one or more pathogenic epitopes associated with the autoimmune disease. The improved method of the present invention includes the administration to a subject of a modified self-vector or self-vectors comprising a polynucleotide encoding a self-polypeptide. In one aspect, the method includes a modified self-vector that allows for increased expression of the self-polypeptide associated with an autoimmune disease in a host cell relative to the unmodified vector. In another, non-mutually exclusive aspect, the method includes a modified self-vector that allows for a secreted autoantigen associated with an autoimmune disease to be encoded as a non-secreted self-polypeptide.

Abstract: This invention relates to methods and compositions for treating or preventing disease comprising the administration of immune modulatory nucleic acids having one or more immune modulatory sequences (IMSs). The invention further relates to the means and methods for the identification of the IMSs for preventing or treating disease, more particularly the treatment and prevention of autoimmune or inflammatory diseases. The invention also relates to the treatment or prevention of disease comprising the administration of the immune modulatory nucleic acids alone or in combination with a polynucleotide encoding self-antigen(s), -proteins(s), -polypeptide(s) or -peptide(s). The present invention also relates to methods and compositions for treating diseases in a subject associated with one or more self-antigen(s), self-proteins(s), -polypeptide(s) or -peptide(s) that are present in the subject and involved in a non-physiological state.

Abstract: This invention provides methods of treating an autoimmune disease in a subject associated with one or more self-protein(s), polypeptide(s), or peptide(s) present in the subject non-physiologically comprising administering to the subject: a self-vector comprising an immunosuppressive vector backbone and a polynucleotide encoding the self-protein(s), polypeptide(s) or peptide(s) associated with the autoimmune disease; and a divalent cation at a concentration greater than physiological levels. Administration of the self-vector comprising a polynucleotide encoding the self-protein(s), polypeptide(s) or peptide(s) modulates an immune response to the self-protein(s), polypeptide(s) or peptide(s) expressed from administration of the self-vector This invention further provides a method of treating multiple sclerosis by administering a self-vector comprising a BHT-1 vector backbone, for example, self-vector BHT-3009 encoding human myelin basic protein (MBP).