Idiopathic pulmonary fibrosis-detection, monitoring, prediction methods

Abstract

The compound of formula (I) is suitable for treating pulmonary fibrosis, such as Idiopathic pulmonary fibrosis in a mammal. Also provided is a method for treatment of pulmonary fibrosis, such as Idiopathic pulmonary fibrosis in a human subject having a galectin-3 level indicative of pulmonary fibrosis or exacerbation of symptoms as well as a method for making said compound.

What is claimed is: 
     
         1 . A method of diagnosing pulmonary fibrosis in a human subject comprising a) measuring a galectin-3 level (e.g. concentration) in a body sample from the human subject using a suitable test method, b) comparing the galectin-3 level to a predetermined reference level, and c) determining whether the galectin-3 level is indicative of diagnosing the subject with pulmonary fibrosis. 
     
     
         2 . The method of  claim 1 , wherein the indicative level of galectin-3 is at least 22 ng/ml. 
     
     
         3 . A method of predicting the prognosis of pulmonary fibrosis in a human subject comprising a) measuring a galectin-3 level (e.g. concentration) in a body sample from the human subject using a suitable test method, and b) determining whether the galectin-3 level is indicative of a poor prognosis or not for the human subject. 
     
     
         4 . The method of  claim 3 , wherein the indicative level of galectin-3 is at least 22 ng/ml. 
     
     
         5 . A method of monitoring or predicting exacerbation of symptoms in a human subject with pulmonary fibrosis comprising a) measuring a galectin-3 level (e.g. concentration) in a body sample from the human subject using a suitable test method, b) comparing the galectin-3 level to a predetermined reference level, b) determine the presence or absence of a galectin-3 level indicative of the development or progression of exacerbation of symptoms, and c) repeating steps a) and b) to monitor or predict the development or progression of the exacerbation of symptoms in the human subject. 
     
     
         6 . The method of  claim 5 , wherein when the indicative level of galectin-3 is below 22 ng/ml treatment of pulmonary fibrosis may be stopped, adjusted or put on hold. 
     
     
         7 . The method of  claim 5 , wherein when the indicative level of galectin-3 is at least 22 ng/ml. 
     
     
         8 . The method of  claim 5 , wherein when the indicative level of galectin-3 is at least 50 ng/ml prophylactic treatment of exacerbation of symptoms is initiated or increased. 
     
     
         9 . The method of  claim 1 , wherein the subject is diagnosed with mild, moderate or aggressive forms of pulmonary fibrosis according to the level of galectin-3. 
     
     
         10 . The method of  claim 5  wherein the predetermined reference level for galectin-3 is in the range from about 10.0 ng/mL to about 25.0 ng/mL, such as in the range from about 13.0 ng/mL to about 19.2 ng/mL. 
     
     
         11 . The method of  claim 1  wherein the suitable test method is selected from an immunoassay, an immunohistochemical assay, a colorimetric assay, a turbidimetric assay, and flow cytometry. 
     
     
         12 . A method of detecting the presence and/or extent of pulmonary fibrosis to diagnose pulmonary fibrosis and/or predict the prognosis of pulmonary fibrosis in a human subject comprising a) measuring a galectin-3 level in a body sample from the human subject using a suitable test method, b) comparing the galectin-3 level to a predetermined reference level, and c) determining whether the galectin-3 level is indicative of diagnosing the subject with pulmonary fibrosis. 
     
     
         13 . The method of  claim 12 , wherein the indicative level of galectin-3 is at least about 22 ng/ml. 
     
     
         14 . A method of monitoring development or progression of or exacerbation of symptoms of pulmonary fibrosis in a human subject, comprising a) measuring a galectin-3 level in a body sample from the subject at least two times with sufficient interval(s) to measure a clinically relevant change, b) comparing the galectin-3 level to a predetermined reference level, and repeating steps a) and b) one or more times to monitor the development or progression of pulmonary fibrosis in the human subject. 
     
     
         15 . The method of  claim 14 , wherein the time period between two measurements is independently selected from about 2 weeks to about 2 years. 
     
     
         16 . The method of  claim 14 , wherein when the level of galectin-3 is below about 22 ng/ml treatment of pulmonary fibrosis is stopped, adjusted or put on hold. 
     
     
         17 . The method of  claim 14 , wherein in step a) further bio-markers are measured, where said markers are linked to Galectin-3 levels. 
     
     
         18 . The method of  claim 14 , wherein the predetermined reference level for galectin-3 is in the range from about 10.0 ng/mL to about 25.0 ng/mL. 
     
     
         19 . The method of  claim 14 , wherein the suitable test method is selected from an immunoassay, an immunohistochemical assay, a colorimetric assay, a turbidimetric assay, and flow cytometry. 
     
     
         20 . The method of  claim 14 , wherein the subject has a galectin-3 blood concentration determined to be within a target range from about 10 ng/ml to about 70 ng/ml.