Immunostimulatory nucleic acids for the treatment of asthma and allergy

Abstract

The invention involves administration of an immunostimulatory nucleic acid alone or in combination with an asthma/allergy medicament for the treatment or prevention of asthma and allergy in subjects. The combination of drugs are administered in synergistic amounts or in various dosages or at various time schedules. The invention also relates to kits and compositions concerning the combination of drugs.

1 - 36 . (canceled)  
     
     
         37 . A method for preventing and/or treating a disorder associated with inflammation comprising administering to a subject suffering from such a disorder a therapeutically acceptable amount of a nucleic acid comprising a non-methylated CpG motif.  
     
     
         38 . The method of  claim 37  wherein the disorder associated with inflammation is associated with mucous formation, airway edema, airway remodeling or subbasement membrane fibrosis.  
     
     
         39 . The method of  claim 37  wherein the inflammatory changes are caused by biological allergens such as bacterial, viral, parasitic or fungal pathogens, asthma initiators such as SO 2 , cold temperatures, or exercise.  
     
     
         40 . The method of  claim 39  wherein the biological allergens are pathogens.  
     
     
         41 . The method of  claim 37  wherein the inflammatory changes are atopic eczema.  
     
     
         42 . The method of  claim 37  wherein the nucleic acid comprising a non-methylated CpG motif comprises at least one non-methylated central CG dinucleotide flanked at the 5′ end by two purine-containing nucleotides and on the 3′ end by two pyrimidine-containing nucleotides.  
     
     
         43 . The method of  claim 37  wherein the non-methylated CpG motif is 
 5′-TCC ATG ACG TTC CTG ACG TT-3′ (SEQ ID NO:69) or 5′-GACGTT-3′;).    
     
     
         44 . The method of  claim 37  wherein the nucleic acid comprising a non-methylated CpG motif is 6 to 100 nucleotides in length, 8 to 50 nucleotides in length, or 8 to 30 nucleotides in length.  
     
     
         45 . The method of  claim 37  wherein the nucleic acid comprising a non-methylated CpG motif is modified.  
     
     
         46 . The method of  claim 45  wherein the modified nucleic acid comprising a non-methylated CpG motif is modified by replacement of phosphodiester bridges with methylphosphonates, phosphoramidates, phosphorothioates or 2′-O-methylribonucleosides or wherein the nucleic acid includes at least one peptide nucleic acid modification.  
     
     
         47 . The method of  claim 46  wherein the peptide nucleic acid modification includes amino acid derivatives that are N-(2-aminoethyl)glycine units.  
     
     
         48 . The method of  claim 37  wherein the nucleic acid comprising a non-methylated CpG motif in a liposome.  
     
     
         49 . A pharmaceutical composition for preventing and/or treating a disorder associated with inflammation comprising a nucleic acid comprising a non-methylated CpG motif selected from the group consisting of: 
 5′-TCC ATG ACG TTC CTG ACG TT-3′ (SEQ ID NO:69) or 5′-GACGTT-3′.    
     
     
         50 . The composition of  claim 49  wherein the nucleic acid comprising a non-methylated CpG motif is 6 to 100 nucleotides in length, 8 to 50 nucleotides in length, or 8 to 30 nucleotides in length.  
     
     
         51 . The composition of  claim 49  wherein the nucleic acid comprising a non-methylated CpG motif is modified.  
     
     
         52 . The composition of  claim 51  wherein the modified nucleic acid comprising a non-methylated CpG motif is modified by replacement of phosphodiester bridges with methylphosphonates, phosphoramidates, phosphorothioates or 2′-O-methylribonucleosides, or wherein the nucleic acid includes at least one peptide nucleic acid modification.  
     
     
         53 . The composition of  claim 52  wherein the peptide nucleic acid modification includes amino acid derivatives that are N-(2-aminoethyl)glycine units.  
     
     
         54 . The composition of  claim 49  wherein the nucleic acid comprising a non-methylated CpG motif is packaged in a liposome.  
     
     
         55 . A process for producing a pharmaceutical composition for preventing and/or treating disorder associated with inflammation comprising mixing at least one nucleic acid comprising a non-methylated CpG motif with at least one and pharmacologically acceptable carrier.  
     
     
         56 . The process of  claim 55  wherein the non-methylated CpG motif is 
 5′-TCC ATG ACG TTC CTG ACG TT-3′ (SEQ ID NO:69) or 5′-GACGTT-3′.    
     
     
         57 . The process of claim of  claim 55  wherein the at least one nucleic acid comprising a non-methylated CpG motif is modified.  
     
     
         58 . The process of claim of  claim 55  wherein the at least one nucleic acid comprising a non-methylated CpG motif is in a liposome.