Pharmaceutical compositions and methods

Abstract

Pharmaceutical compositions and kits including a tyrosine hydroxylase inhibitor; melanin, a melanin promoter, or a combination thereof; a p450 3A4 promoter; and a leucine aminopeptidase inhibitor are provided. Also provided are methods of treating cancer in a subject, comprising administering an effective amount of a tyrosine hydroxylase inhibitor, a melanin promoter, a p450 3A4 promoter, and a leucine aminopeptidase inhibitor to the subject in need thereof. Also provided are methods of reducing cell proliferation in a subject comprising administering an effective amount of a tyrosine hydroxylase inhibitor, a melanin promoter, a p450 3A4 promoter, and a leucine aminopeptidase inhibitor to the subject in need thereof.

What is claimed: 
     
         1 . A pharmaceutical composition comprising a tyrosine hydroxylase inhibitor; and melanin, a melanin promoter, or a combination thereof. 
     
     
         2 . The pharmaceutical composition of  claim 1  wherein said tyrosine hydroxylase inhibitor is α-methyl-DL-tyrosine. 
     
     
         3 . The pharmaceutical composition of  claim 1  comprising melanin. 
     
     
         4 . A pharmaceutical composition comprising a tyrosine hydroxylase inhibitor and a p450 3A4 promoter. 
     
     
         5 . The pharmaceutical composition of  claim 4  wherein said tyrosine hydroxylase inhibitor is α-methyl-DL-tyrosine. 
     
     
         6 . The pharmaceutical composition of  claim 4  wherein said p450 3A4 promoter is 5,5-diphenylhydantoin. 
     
     
         7 . A pharmaceutical composition comprising a tyrosine hydroxylase inhibitor and a leucine aminopeptidase inhibitor. 
     
     
         8 . The pharmaceutical composition of  claim 7  wherein said tyrosine hydroxylase inhibitor is α-methyl-DL-tyrosine. 
     
     
         9 . The pharmaceutical composition of  claim 7  wherein said leucine aminopeptidase inhibitor is rapamycin or N-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutyryl]-L-leucine. 
     
     
         10 . A pharmaceutical composition comprising melanin, a melanin promoter, or a combination thereof; a p450 3A4 promoter; and a leucine aminopeptidase inhibitor. 
     
     
         11 . The pharmaceutical composition of  claim 10  comprising melanotan II. 
     
     
         12 . The pharmaceutical composition of  claim 10  wherein said p450 3A4 promoter is 5,5-diphenylhydantoin. 
     
     
         13 . The pharmaceutical composition of any one of  claim 10  wherein said leucine aminopeptidase inhibitor is rapamycin or N-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutyryl]-L-leucine. 
     
     
         14 . A kit comprising a pharmaceutical composition of  claim 1  and a pharmaceutical composition according to  claim 4 . 
     
     
         15 . The kit of  claim 14  further comprising a pharmaceutical composition of  claim 7 . 
     
     
         16 . The kit of  claim 15  further comprising a pharmaceutical composition of  claim 10 . 
     
     
         17 . The kit of  claim 16  further comprising a pharmaceutical composition comprising a tyrosine hydroxylase inhibitor. 
     
     
         18 . A method for treating cancer comprising administering to a patient in need thereof a pharmaceutical composition of  claim 1 , a pharmaceutical composition of  claims 7 , a pharmaceutical composition of  claim 10 , and a pharmaceutical composition comprising a tyrosine hydroxylase inhibitor. 
     
     
         19 . The method of  claim 18  wherein said pharmaceutical compositions are administered to said patient within a 24 hour period. 
     
     
         20 . The method of  claim 18  wherein said pharmaceutical compositions are administered to said patient five days per week for six weeks.