COMBINATIONS OF MODALITIES FOR THE TREATMENT OF DIABETES
A method of treating, preventing, or delaying the progression of Type 1 diabetes mellitus by administering an effective amount of a fusion protein composition comprising a T-cell co-stimulation antagonist and a portion of an immunoglobulin molecule and an effective amount of a Type 1 diabetes autoantigen. The method includes, for example, administering a cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) molecule and a Type 1 diabetes autoantigen. Pharmaceutical compositions are also provided herewith.
1 - 19 . (canceled)
20 . A pharmaceutical composition comprising:
a cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) fusion protein,
an autoantigen selected from the group consisting of: preproinsulin, GAD 65, ICA512/IA-2, HSP60, carboxypeptidase H, peripherin, and ganglioside or an immunologically active fragment or variant thereof, and
a pharmaceutically acceptable carrier.
21 . The pharmaceutical composition of claim 20 , wherein said CTLA4 fusion protein is abatacept.
22 . The pharmaceutical composition of claim 20 , wherein said autoantigen is preproinsulin or an immunologically active fragment or variant thereof.
23 . The pharmaceutical composition of claim 22 , wherein said preproinsulin fragment is insulin B-chain or an immunologically active fragment or variant thereof.
24 . The pharmaceutical composition of claim 23 , wherein said insulin B-chain fragment comprises amino acids 33-47 of SEQ ID NO:1.
25 . The pharmaceutical composition of claim 20 , wherein said pharmaceutically acceptable carrier is an oil-based carrier.
26 . The pharmaceutical composition of claim 25 , wherein said oil-based carrier is IFA or Montanide ISA.
27 . The pharmaceutical composition of claim 20 , comprising about 250 mg to about 2000 mg of the fusion protein and about 0.5 to about 10 mg of the autoantigen.