Methods of Use for Recombinant Human Secretoglobins

Abstract

Methods of synthetically producing, formulating and using secretoglobins SCGB1A1, SCGB3A2, and SCGB3A1 are provided. Methods of using secretoglobins SCGB1A1, SCGB3A2, and SCGB3A1 as therapeutic agents to affect long term patient outcomes, such as preventing severe respiratory exacerbations of underlying conditions that require medical intervention, including hospitalization are provided. Methods of producing recombinant human secretoglobins, analytical methods, pharmaceutical compositions, and methods of use to prevent the long term sequelae of acute and chronic respiratory conditions are provided.

We claim: 
     
         1 . A method of preventing hospitalization due to a severe respiratory exacerbation in a patient with acute lung injury comprising the steps of:
 (a) administering rhCC10 to a patient having an acute lung injury,   wherein the patient is not re-hospitalized for at least ten months after administration of rhCC10.   
     
     
         2 . A method of preventing hospitalization due to a severe respiratory exacerbation in a patient with who experiences frequent respiratory exacerbations comprising the steps of:
 (a) administering rhCC10 to a patient having frequent respiratory exacerbations,   wherein the patient is not re-hospitalized for at least one month after administration of rhCC10.   
     
     
         3 . A method of preventing hospitalization due to a severe respiratory exacerbation in a patient with a chronic respiratory condition comprising the steps of:
 (a) administering rhCC10 to a patient having a chronic respiratory condition,   wherein the patient is not re-hospitalized for at least one month after administration of rhCC10.   
     
     
         4 . The method of  claim 1  wherein the severe respiratory exacerbation is caused by COPD or asthma. 
     
     
         5 . The method of  claim 2  wherein the severe respiratory exacerbation is caused by COPD or asthma. 
     
     
         6 . The method of  claim 3  wherein the severe respiratory exacerbation is caused by COPD or asthma. 
     
     
         7 . A method of preventing hospitalization due to a severe respiratory exacerbation in a patient with acute lung injury comprising the steps of:
 (a) administering rhSCGB3A2 to a patient having an acute lung injury,   wherein the patient is not re-hospitalized for at least ten months after administration of rhCC10.   
     
     
         8 . A method of preventing hospitalization due to a severe respiratory exacerbation in a patient with who experiences frequent respiratory exacerbations comprising the steps of:
 (a) administering rhSCGB3A2 to a patient having frequent respiratory exacerbations,   wherein the patient is not re-hospitalized for at least two months after administration of rhSCGB3A2.   
     
     
         9 . A method of preventing hospitalization due to a severe respiratory exacerbation in a patient with a chronic respiratory condition comprising the steps of:
 (a) administering rhSCGB3A2 to a patient having a chronic respiratory condition,   wherein the patient is not re-hospitalized for at least one month after administration of rhSCGB3A2.   
     
     
         10 . The method of  claim 7  wherein the severe respiratory exacerbation is caused by pulmonary fibrosis or bronchiectasis. 
     
     
         11 . The method of  claim 8  wherein the severe respiratory exacerbation is caused by pulmonary fibrosis or bronchiectasis. 
     
     
         12 . The method of  claim 9  wherein the severe respiratory exacerbation is caused by pulmonary fibrosis or bronchiectasis. 
     
     
         13 . A composition of matter comprising recombinant human SCGB3A2 protein having an N-terminus ATA, namely SEQ ID 1. 
     
     
         14 . The protein of  claim 13 , wherein the protein inhibits PLA 2  enzymes. 
     
     
         15 . The protein of  claim 13 , wherein the protein migrates in an isoelectric focusing gel corresponding to an isoelectric point at or between 6.3-6.7. 
     
     
         16 . The protein of  claim 13  wherein the protein further comprises a homodimer. 
     
     
         17 . The protein of  claim 14  wherein the protein further comprises a homodimer having a pl of 6.7. 
     
     
         18 . A process for synthesizing recombinant human SCGB3A2 comprising: using a UBL fusion protein and UBL protease that recognizes the fusion partner and cleaves between the fusion partner and SCGB3A2, to release an intact SCGB3A2 protein, namely SEQ ID 1.