Biomarker SPAG5

Abstract

There has been a recent shift in cancer therapy from one size fits all to a personalized and tailored treatment for individual patients to increase efficiency and avoid unnecessary toxicity. This invention relates to a method of determining the prognosis and suitable treatment of cancer in a subject by measuring the level of expression of SPAG5. In particular, it relates to a method where high expression of SPAG5 in tumour cells correlates with aggressive tumours.

1 . A method for obtaining an indication useful in determining the appropriate treatment for a subject comprising the steps of:
 i. determining the expression level of SPAG5 in a tumour tissue sample from said subject; and   ii. comparing the expression level of SPAG5 determined in step (i) with one or more reference values.   
     
     
         2 . A method according to  claim 1  wherein high expression of SPAG5 indicates that the tumour is likely to be sensitive to a platinum chemotherapy agent or an anthracycline. 
     
     
         3 . A method according to  claim 1  wherein low expression of SPAG5 indicates that the tumour is likely to be resistant to a platinum chemotherapy agent or an anthracycline. 
     
     
         4 . A method according to  claim 1  wherein high expression of SPAG5 indicates that the tumour is likely to be sensitive to a combination of an anthracycline and herceptin. 
     
     
         5 . A method according to  claim 1  wherein high expression of SPAG5 indicates that the tumour may have an aggressive phenotype and is more likely to metastasise. 
     
     
         6 . The method according to  claim 1  wherein the expression level of SPAG5 is determined by evaluating histological staining or by evaluating SPAG5 mRNA levels. 
     
     
         7 . The method according to  claim 6  wherein the expression level of SPAG5 is determined by histological staining using the HEAD score and wherein a HEAD score of less than or equal to 100 is considered low or negative and a head score of greater than 100 is considered high. 
     
     
         8 . The method according to  claim 1  wherein the reference value is the level of expression in normal tissues or is standard histo-pathological criteria. 
     
     
         9 . The method of  claim 1  wherein the method is carried out in vitro. 
     
     
         10 . The method of  claim 1  wherein the subject is a human. 
     
     
         11 . The method according to  claim 1  further comprising the step of administering a suitable treatment for cancer. 
     
     
         12 . A kit for use m obtaining an indication useful in determining the most appropriate treatment for a subject, wherein the kit comprises at least one agent for determining the expression level of SPAG5 in a tumour tissue sample provided from the subject. 
     
     
         13 . The kit of  claim 11  wherein the agent is an antibody or a labelled antibody that binds to SPAG5 protein. 
     
     
         14 . The kit of  claim 12  further comprising instructions for suitable operational parameters in the form of a label or separate insert. 
     
     
         15 . The kit of  claim 12  further comprising one or more SPAG5 protein samples to be used as standard(s) for calibration and comparison. 
     
     
         16 - 21 . (canceled) 
     
     
         22 . A modulator of SPAG5 activity for use in the treatment of cancer. 
     
     
         23 . The modulator of SPAG5 activity according to  claim 22 , wherein the modulator is an antibody that specifically binds to SPAG5. 
     
     
         24 . The modulator according to  claim 22  wherein the modulator is a monoclonal antibody that specifically binds to SPAG5. 
     
     
         25 . The modulator according to  claim 22  wherein the modulator is an antagonist of SPAG5 activity. 
     
     
         26 . The modulator according to  claim 22  wherein the cancer is a tumour that has increased SPAG15 expression. 
     
     
         27 - 30 . (canceled)