Use of recombinant human uteroglobin in treatment of inflammatory and fibrotic conditions

Abstract

Method for treatment of inflammatory and fibrotic conditions in vivo using pure rhUG is disclosed. Method for treating or preventing inflammatory or fibrotic conditions characterized by a deficiency of endogenous fictional UG is also disclosed. Compositions containing pure rhUG, optionally also containing lung surfactant, and assay procedures for detection of UG-fibronectin complexes, are also provided.

What is claimed is:  
     
         1 . Method for inhibiting PLA 2  enzymes in vivo in a mammal in need of such treatment, said method comprising the step of administering to said mammal an PLA 2  inhibiting effective amount of rhUG.  
     
     
         2 . Method according to  claim 1 , wherein said rhUG is administered in an amount of a single bolus of 20 ng/kg to 500 mg/kg, in single or multiple doses, or as a continuous infusion of up to 10 grams.  
     
     
         3 . Method according to  claim 1 , wherein said rhUG is administered in association with a lung surfactant.  
     
     
         4 . Method according to  claim 3 , wherein said lung surfactant is present in an amount of about 20-80% by weight.  
     
     
         5 . Method according to  claim 1 , wherein said rhUG is administered by injection.  
     
     
         6 . Method according to  claim 1 , wherein said rhUG is administered as a semi-aerosol via an intratracheal tube.  
     
     
         7 . Method according to  claim 1  wherein said rhUG has a purity level of 98-100%.  
     
     
         8 . Method for treating an inflammatory condition in vivo in a patient in need such treatment, said method comprising the step of administering to said patient an anti-inflammatory effective amount of rhUG.  
     
     
         9 . Method according to  claim 8 , wherein said inflammatory condition is neonatal RDS.  
     
     
         10 . Method according to  claim 8 , wherein said inflammatory condition is adult RDS.  
     
     
         11 . Method according to  claim 8 , wherein said rhUG is administered in an amount of a single bolus of 20 ng/kg to 500 mg/kg, in single or multiple doses, or as a continuous infusion of up to 10 grams.  
     
     
         12 . Method according to  claim 8  wherein said rhUG is administered in association with a lung surfactant.  
     
     
         13 . Method according to  claim 12 , wherein said lung surfactant is p resent in an amount of about 20-80% by weight.  
     
     
         14 . Method according to  claim 8 , wherein said rhUG is administered by injection.  
     
     
         15 . Method according to  claim 8 , wherein said rhUG is administered as a semi-aerosol via an intratracheal tube.  
     
     
         16 . Method according to  claim 8 , wherein said rhUG has a purity level of 98-100%.  
     
     
         17 . Method for treating or preventing a fibrotic condition in a patient in need of such treatment, said method comprising the step of administering to a patient in need of such treatment a fibronectin binding effective amount of rhUG.  
     
     
         18 . Method according to  claim 17 , wherein said fibrotic condition is pulmonary fibrosis.  
     
     
         19 . Method according to  claim 17 , wherein said fibrotic condition is renal fibrosis.  
     
     
         20 . Method according to  claim 17 , wherein said rhUG is administered in an amount of a single bolus of 20 ng/kg to 500 mg/kg, in single or multiple doses, or as a continuous infusion of up to 10 grams.  
     
     
         21 . Method according to  claim 17 , wherein said rhUG is administered in association with a lung surfactant.  
     
     
         22 . Method according to  claim 17 , wherein said rhUG is administered by injection.  
     
     
         23 . Method according to  claim 17 , wherein said rhUG is administered as a semi-aerosol via an intratracheal tube.  
     
     
         24 . Method for treating or preventing an inflammatory or fibrotic condition characterized by a deficiency of endogenous functional UG, said method comprising the step of administering to a patient in need of such treatment a compensating amount of rhUG.  
     
     
         25 . A pharmaceutical composition comprising a PLA 2  inhibiting effective amount of rhUG in association with a pharmaceutical carrier or diluent.  
     
     
         26 . A pharmaceutical composition comprising a fibronectin binding effective amount of rhUG in association with a pharmaceutical carrier or diluent.  
     
     
         27 . A pharmaceutical composition according to  claim 25 , and further including a lung surfactant.  
     
     
         28 . A pharmaceutical composition according to  claim 26 , and further including a lung surfactant.  
     
     
         29 . Assay method for assaying for uterglobin fibronectin complex in a clinical sample, comprising: 
 (a) contacting a clinical sample suspected of containing uteroglobin fibronectin complex with an antigen capture agent immobilized on an insoluble support;    (b) introducing an antigen detection agent to said sample; and    (c) detecting the presence of any said complex bound to said support.    
     
     
         30 . Method according to  claim 29 , wherein said antigen capture agent is an anti-uteroglobin antibody.  
     
     
         31 . Method according to  claim 29 , wherein said antigen detection agent is an antibody specific for fibronectin.