Treatment methods using adenovirus

Abstract

The invention provides methods of reducing or decreasing a size of a tumor or eliminating a tumor by inhibiting, decreasing, or reducing neo-vascularization or angiogenesis in a tumor in a patient by administering an adenovirus comprising a nucleic acid construct comprising a FAS-chimera gene operably linked to an endothelial cell-specific promoter. Also provided is a homogeneous population of an adenovirus comprising a FAS-chimera gene operably linked to an endothelial cell-specific promoter and its uses thereof.

1 .- 107 . (canceled) 
     
     
         108 . A pharmaceutical composition comprising an adenovirus having European Collection of Cell Cultures (ECACC) deposit designation 13021201, wherein the composition is formulated in a buffer. 
     
     
       109. The pharmaceutical composition of  claim 108 , wherein the adenovirus is at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or 100% pure. 
     
     
         110 . The pharmaceutical composition of  claim 108 , wherein the buffer comprises one or more buffer substances selected from the group consisting of phosphates, glycine, sorbic acid, potassium sorbate, partial glyceride mixtures of saturated vegetable fatty acids, water, salts, protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, and zinc salts. 
     
     
         111 . The pharmaceutical composition of  claim 108 , wherein the composition comprises a homogeneous population of the adenovirus. 
     
     
         112 . The pharmaceutical composition of  claim 108 , wherein the composition is formulated for administration to a mammal. 
     
     
         113 . The pharmaceutical composition of  claim 112 , wherein the mammal is a human. 
     
     
         114 . The pharmaceutical composition of  claim 108 , wherein the composition is formulated for systemic administration. 
     
     
         115 . The pharmaceutical composition of  claim 114 , wherein the systemic administration is intravenous. 
     
     
         116 . The pharmaceutical composition of  claim 108 , wherein the composition is co-formulated with one or more additional therapeutic agents. 
     
     
         117 . The pharmaceutical composition of  claim 108 , wherein the composition is formulated in a fixed unit dose. 
     
     
         118 . The pharmaceutical composition of  claim 117 , wherein the unit dose is about 1×10 12  virus particles per milliliter. 
     
     
         119 . The pharmaceutical composition of  claim 108 , wherein the composition is formulated as a single bolus dose, an infusion, or a loading bolus dose. 
     
     
         120 . A pharmaceutical composition comprising an adenovirus having European Collection of Cell Cultures (ECACC) deposit designation 13021201 and a pharmaceutically acceptable carrier, wherein the composition is formulated as a sterile solution and is frozen or maintained on ice. 
     
     
         121 . The pharmaceutical composition of  claim 120 , wherein the adenovirus is at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or 100% pure. 
     
     
         122 . The pharmaceutical composition of  claim 120 , wherein the pharmaceutically acceptable carrier is selected from ion exchangers, alumina, aluminum stearate, lecithin, serum proteins, such as human serum albumin, buffer substances such as phosphates, glycine, sorbic acid, potassium sorbate, partial glyceride mixtures of saturated vegetable fatty acids, water, salts or electrolytes, such as protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salts, colloidal silica, magnesium trisilicate, polyvinyl pyrrolidone, cellulose-based substances, polyethylene glycol, sodium carboxymethylcellulose, polyacrylates, waxes, polyethylene-polyoxypropylene-block polymers, polyethylene glycol and wool fat. 
     
     
         123 . The pharmaceutical composition of  claim 120 , wherein the composition is formulated for administration to a mammal. 
     
     
         124 . The pharmaceutical composition of  claim 123 , wherein the mammal is a human. 
     
     
         125 . The pharmaceutical composition of  claim 120 , wherein the composition is formulated for systemic administration. 
     
     
         126 . The pharmaceutical composition of  claim 125 , wherein the systemic administration is intravenous. 
     
     
         127 . The pharmaceutical composition of  claim 120 . wherein the composition is co-formulated with one or more additional therapeutic agents. 
     
     
         128 . The pharmaceutical composition of  claim 120 , wherein the sterile solution is formulated in a single use vial. 
     
     
         129 . The pharmaceutical composition of  claim 128 , wherein the vial contains 1.1 milliliters of the adenovirus at a concentration of about 1×10 virus particles per milliliter. 
     
     
         130 . A pharmaceutical composition comprising an adenovirus having European Collection of Cell Cultures (ECACC) deposit designation 13021201, wherein the composition is formulated in PBS and glycerol. 
     
     
         131 . The pharmaceutical composition of  claim 130 , wherein the composition is formulated for administration to a mammal. 
     
     
         132 . The pharmaceutical composition of  claim 131 , wherein the mammal is a human. 
     
     
         133 . The pharmaceutical composition of  claim 130 , wherein the composition is formulated for systemic administration. 
     
     
         134 . The pharmaceutical composition of  claim 133 , wherein the systemic administration is intravenous. 
     
     
         135 . A pharmaceutical composition comprising an adenovirus having European Collection of Cell Cultures (ECACC) deposit designation 13021201, wherein the composition is formulated in a buffer as a sterile solution. 
     
     
         136 . The pharmaceutical composition of  claim 135 , wherein the adenovirus is at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or 100% pure. 
     
     
         137 . The pharmaceutical composition of  claim 135 , further comprising glycerol.