Insulin independence among patients with diabetes utilizing an optimized hamster reg3 gamma peptide

Abstract

Embodiments of the present invention provide for novel therapies, pharmaceutical compositions and methods for insulin independence utilizing a new optimized hamster Reg3 gamma peptide, which is new to the art and has not previously been considered for development in the 30 year history since its discovery. Methods, pharmaceutical compositions and therapies novel to the prior art are utilized in this invention to render patients with recent onset and existing type 1 diabetes insulin independent by an optimized hamster Reg3 gamma peptide and an immune tolerance agent for type 1 patients to become insulin independent and used alone without an immune tolerance agent for type 2 diabetes. While not wishing to be bound by theory, optimized Reg3 gamma peptides increases beta cell generation by its demonstrated properties shown within of transforming ductal pancreatic cells into new islets.

1 . A method of treating type 1 or type 2 diabetes, comprising:
 administering to a subject a therapeutically effective amount of a pharmaceutical composition comprising a peptide comprising the amino acid sequence of SEQ ID NO:1 and an immune tolerance agent.   
     
     
         2 . The method of  claim 2 , wherein the immune tolerance agent is Cyclosporine. 
     
     
         3 . A method of treating type 1 or type 2 diabetes, comprising:
 administering to a subject a therapeutically effective amount of a composition comprising an optimized Reg3 gamma peptide comprising any combination of addition of an N-terminal cysteine, acetylation at the N-terminus, amidation at the C-terminus, and/or PEGylation at either terminus.   
     
     
         4 . The method of  claim 3 , wherein the optimized Reg3 gamma peptide comprises the structure set forth in any one of SEQ ID NOS:2-7. 
     
     
         5 . The method of  claim 3 , wherein the optimized Reg3 gamma peptide comprises the sequence of SEQ ID NO:1 that is acetylated at the N-terminus, amidated at the C-terminus, and/or PEGylated at either terminus. 
     
     
         6 . The method of  claim 5 , wherein the N-terminus or C-terminus of the optimized Reg 3 gamma peptide is covalently bonded to a dimeric maleimide activated 40Kd PEG construct. 
     
     
         7 . The method of  claim 3 , wherein the optimized Reg 3 gamma peptide comprises the sequence of SEQ ID NO:3 that is acetylated at the N-terminus, amidated at the C-terminus, and/or PEGylated at either terminus. 
     
     
         8 . The method of  claim 7 , wherein the N-terminus or C-terminus of the optimized Reg 3 gamma peptide is covalently bonded to a dimeric maleimide activated 40Kd PEG construct. 
     
     
         9 . The method of  claim 3 , wherein the optimized Reg 3 gamma peptide is an isolated peptide homodimer, wherein each molecule consists of the amino acid sequence of SEQ ID NO:3 and the homodimer is obtained by dimerization through the free cysteine in the two molecules of the dimer. 
     
     
         10 . The method of  claim 9 , wherein the optimized Reg 3 gamma peptide homodimer is acetylated at the N-terminus, amidated at the C-terminus, and/or PEGylated at either terminus. 
     
     
         11 . The method of  claim 3 , wherein the composition further comprises an immune tolerance agent. 
     
     
         12 . The method of  claim 11 , wherein the immune tolerance agent is Cyclosporine. 
     
     
         13 . The method of  claim 3 , wherein the compositions are administered extracorporeally, intracranially, intravaginally, intraanally, subcutaneously, intradermally, intracardiac, intragastric, intravenously, intramuscularly, by intraperitoneal injection, transdermally, intranasally, or by inhalation. 
     
     
         14 . The method of  claim 3 , wherein the composition is formulated for systemic administration. 
     
     
         15 . The method of  claim 3 , wherein the composition comprises a targeting agent for targeted administration to specific locations, receptors, cells, tissues, organs, or organ systems.