Compositions and methods for therapeutic use

Abstract

A method and pharmaceutical composition for the treatment of cancer using a gene delivery system, such as a viral vector delivery system, comprising a therapeutic gene such as p53 or a retinoblastoma tumor suppressor gene wherein the gene delivery system is formulated in a buffer comprising a delivery-enhancing agent such as ethanol or a detergent.

1 . A method of administering a therapeutic agent to the urinary bladder comprising intravesically administering to the urinary bladder a therapeutically effective amount of the therapeutic agent formulated in a buffer comprising a detergent. 
   
   
       2 . The method of  claim 1 , wherein the therapeutic agent is a protein. 
   
   
       3 . The method of  claim 1 , wherein the therapeutic agent is a nucleic acid. 
   
   
       4 . The method of  claim 3 , wherein the nucleic acid is a tumor suppressor gene. 
   
   
       5 . The method of  claim 1 , wherein the detergent is Big CHAP. 
   
   
       6 . (canceled) 
   
   
       7 . The method of  claim 3 , wherein the nucleic acid encodes a cytokine. 
   
   
       8 . The method of  claim 7 , wherein the cytokine is an interferon α, β, γ, or δ. 
   
   
       9 - 10 . (canceled) 
   
   
       11 . A pharmaceutical composition comprising a therapeutically effective amount of a therapeutic agent formulated in a buffer comprising a detergent. 
   
   
       12 . The pharmaceutical composition of  claim 11 , wherein the therapeutic agent is a protein. 
   
   
       13 . The pharmaceutical composition of  claim 11 , wherein the therapeutic agent is a nucleic acid. 
   
   
       14 . The pharmaceutical composition of  claim 13 , wherein the nucleic acid is a tumor suppressor gene. 
   
   
       15 - 16 . (canceled) 
   
   
       17 . The pharmaceutical composition of  claim 11 , wherein the detergent is Big CHAP. 
   
   
       18 . (canceled) 
   
   
       19 . (canceled) 
   
   
       20 . A method of treating bladder cancer comprising intravesically administering to the urinary bladder of a subject having the bladder cancer a therapeutically effective amount of a therapeutic gene contained within a gene delivery system that is formulated in a buffer comprising a delivery-enhancing agent. 
   
   
       21 . The method of  claim 20  wherein the gene delivery system is a viral vector delivery system. 
   
   
       22 . The method of  claim 20  wherein the gene delivery system is a recombinant adenoviral vector delivery system. 
   
   
       23 . The method of  claim 20  wherein the therapeutic gene is a tumor suppressor gene. 
   
   
       24 - 27 . (canceled) 
   
   
       28 . The method of  claim 20  wherein the delivery-enhancing agent is a detergent. 
   
   
       29 . The method of  claim 28 , wherein the detergent is Big CHAP. 
   
   
       31 - 39 . (canceled) 
   
   
       40 . The method of  claim 20 , wherein the gene encodes a cytokine. 
   
   
       41 . The method of  claim 20 , wherein the gene encodes an interferon α, β, γ, or δ.