Mutant Peptides And Methods Of Treating Subjects Using The Same

Abstract

The disclosure relates to a pharmaceutical composition comprising any one or combination of PIF peptides or analogs or pharmaceutically acceptable salts thereof. Methods of treating autoimmune disease using the one or a combination of PIF peptide or analogs thereof or pharmaceutically acceptable salts thereof is also disclosed.

1 . A composition comprising a PIF analog comprising an amino acid sequence that is at least 93% homologous to SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The composition of  claim 1 , wherein the PIF analog comprises an amino acid sequence that is at least 93% homologous to SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, or a pharmaceutically acceptable salt thereof. 
     
     
         3 . A pharmaceutical composition comprising:
 i) a therapeutically effective amount of the composition of  claim 1  or a pharmaceutically acceptable salt thereof; and   ii) a pharmaceutically acceptable carrier.   
     
     
         4 . The pharmaceutical composition of  claim 3 , wherein the PIF analog comprises an amino acid sequence that is at least 93% homologous to SEQ ID NO: 8, SEQ ID NO: 9, or a pharmaceutically acceptable salt thereof. 
     
     
         5 . The pharmaceutical composition of  claim 3 , wherein the therapeutically effective amount is from about 1 milligram to about 4 grams. 
     
     
         6 . The pharmaceutical composition of  claim 3 , wherein the therapeutically effective amount is about 70 milligrams. 
     
     
         7 . A method of treating or preventing autoimmune disease in a subject in need thereof, the method comprising administering to the subject at least one pharmaceutical composition comprising:
 i) a therapeutically effective amount of a pre-implantation factor (PIF) analog, or a pharmaceutically acceptable salt thereof; and   ii) a pharmaceutically acceptable carrier.   
     
     
         8 . The method of  claim 7 , wherein the pharmaceutically acceptable carrier is sterile and pyrogen-free water or sterile and pyrogen-free Lactated ringer's solution. 
     
     
         9 . The method of  claim 7 , wherein the therapeutically effective amount is from about 0.1 mg/kg to about 1.0 mg/kg, wherein kg is kilograms of the subject and mg is milligrams of the therapeutically effective dose. 
     
     
         10 . The method of  claim 7 , wherein the therapeutically effective amount is from about 0.1 mg/kg to about 5.0 mg/kg, wherein kg is kilograms of the subject and mg is milligrams of the therapeutically effective dose. 
     
     
         11 . The method of  claim 7 , wherein the PIF analog is any one or plurality of: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6 SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and/or SEQ ID NO: 10, or a pharmaceutically acceptable salt thereof. 
     
     
         12 . The method of  claim 7 , wherein the step of administering to the subject at least one pharmaceutical composition comprises administering a therapeutically effective amount of the PIF analog or pharmaceutically acceptable salt thereof from about 0.001 mg/kg to about 200 mg/kg. 
     
     
         13 . The method of  claim 7 , wherein the step of administering to the subject at least one pharmaceutical composition comprises administering a therapeutically effective amount of the PIF analog or pharmaceutically acceptable salt thereof from about 0.5 mg/kg to about 5 mg/kg, wherein kg is kilograms of the subject and mg is milligrams of the therapeutically effective dose. 
     
     
         14 . A method of treating or preventing diabetes in a subject in need thereof, the method comprising administering to the subject at least one pharmaceutical composition comprising:
 i) a therapeutically effective amount of a pre-implantation factor (PIF) analog, or a pharmaceutically acceptable salt thereof; and   ii) a pharmaceutically acceptable carrier.   
     
     
         15 . The method of  claim 14 , wherein the pharmaceutically acceptable carrier is sterile and pyrogen-free water or sterile and pyrogen-free Lactated ringer's solution. 
     
     
         16 . The method of  claim 14 , wherein the therapeutically effective amount is from about 0.1 mg/kg to about 1.0 mg/kg, wherein kg is kilograms of the subject and mg is milligrams of the therapeutically effective dose. 
     
     
         17 . The method of  claim 14 , wherein the therapeutically effective amount is from about 0.1 mg/kg to about 5.0 mg/kg, wherein kg is kilograms of the subject and mg is milligrams of the therapeutically effective dose. 
     
     
         18 . The method of  claim 14 , wherein the PIF analog is any one or plurality of: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6 SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and/or SEQ ID NO: 10, or a pharmaceutically acceptable salt thereof. 
     
     
         19 . The method of  claim 14 , wherein the at least one pharmaceutical composition is administered via intravenously, intramuscularly, topically, intradermally, transmucosally, subcutaneously, sublingually, transdermally, orally, buccally, intraocularly, intravaginally, intrarectally, intraductally, intrathecally, subdurally, extradurally, intraventricularly, intraarticularly, intraperitoneally, into the pleural cavity, by inhalation, by depot injections, or by implants. 
     
     
         20 . A method of binding an insulin degrading enzyme (IDE) in a subject in need thereof, the method comprising administering to the subject at least one pharmaceutical composition comprising:
 i) a therapeutically effective amount of a pre-implantation factor (PIF) analog, or a pharmaceutically acceptable salt thereof; and   ii) a pharmaceutically acceptable carrier.   
     
     
         21 . The method of  claim 20 , wherein the PIF analog is any one or plurality of: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6 SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and/or SEQ ID NO: 10, or a pharmaceutically acceptable salt thereof.