Mutated e. coli enterotoxins as anti-inflammatory agents

A method of reducing symptoms of inflammation in a subject in need thereof, said method comprising administering by an oral route, a topical route, a rectal route, an intravenous route, a transdermal route, an intramuscular route, an endoscopic route, or a parenteral route to said subject a composition comprising a therapeutically effective amount of:

• (a) (i) an E. coli heat labile enterotoxin (“LT”) non-toxic A subunit which does not have activity as an adjuvant, (ii) a LT non-toxic A1 subunit which does not have activity as an adjuvant, or, (iii) a combination of said non-toxic A subunit and said non-toxic A1 subunit, and, (b) a carrier which causes internalization of said non-toxic A subunit or non-toxic A1 subunit, or combination thereof, into cells, wherein said inflammation is inflammatory bowel disease, optionally wherein said inflammatory bowel disease is ulcerative colitis or Crohn's disease, and wherein said non-toxic A subunit, non-toxic A1 subunit, or combination thereof has a substitution mutation in said A subunit, said A1 subunit, or both, in an amino acid residue selected from the group consisting of E112, E110, and R25, said mutation consisting of:
• E112D, E112K, E112R, E112G, E112A, E112V, E112L, E112I, E112M, E112S, E112T, E112N, E110K, E110R, E110G, E110A, E110V, E110L, E110I, E110M, E110S, E110T, E112N, R25G, R25D, R25E, R25A, R25V, R25L, R25I , R25M, R25S, or R25T.