USRE46534EExpiredUtility

Composition and methods for the diagnosis of immune related diseases involving the PRO52254 polypeptide

96
Assignee: GENENTECH INCPriority: Sep 11, 2002Filed: Apr 29, 2015Granted: Sep 5, 2017
Est. expirySep 11, 2022(expired)· nominal 20-yr term from priority
A61P 37/02A61P 37/00A61P 9/00A61P 3/10A61P 37/04A61P 7/06A61P 37/06A61P 37/08A61P 25/00A61P 29/00A61P 27/16C07K 14/47C07K 16/18A61P 19/02A61P 11/00C12Q 2600/158A61P 17/00C12Q 1/6883G01N 2800/24A61P 17/06A61P 13/12C12N 2799/026G01N 2800/205A61P 11/06G01N 2800/065A61K 2039/505A61P 17/02A61P 1/16G01N 2500/10
96
PatentIndex Score
32
Cited by
192
References
37
Claims

Abstract

The present invention relates to compositions containing a novel protein and methods of using those compositions for the diagnosis and treatment of immune related diseases involving detection of the PRO52254 polypeptide.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
       1. A method of diagnosing an immune related disease in a mammal, wherein the immune related disease is psoriasis or inflammatory bowel disease, said method comprising the steps of:
 ( 1 ) detecting the level of expression of a gene encoding the polypeptide of SEQ ID NO:2 in a test sample of tissue cells obtained from the mammal,   ( 2 ) detecting the level of expression of the gene encoding the polypeptide of SEQ ID NO: 2 in a control sample of known normal tissue cells of the same cell type, and   ( 3 ) diagnosing the immune related disease in the mammal when the level of expression of said gene in the test sample is higher as compared to the level of expression of said gene in the control sample.   
     
     
       2. The method of  claim 1 , wherein the immune related disease is psoriasis. 
     
     
       3. The method of  claim 1 , wherein the immune related disease is inflammatory bowel disease. 
     
     
       4. The method of  claim 1 , wherein the level of expression of the gene encoding the polypeptide of SEQ ID NO:2 is detected with an antibody that specifically binds to the polypeptide of SEQ ID NO:2, or fragments thereof. 
     
     
       5. The method of  claim 1 , wherein the mammal is diagnosed of the immune related disease when the level of expression of said gene is at least 2 fold greater in the test sample as compared to the level of expression of said gene in the control sample. 
     
     
       6. The method of  claim 1 , wherein the level of expression of the gene encoding the polypeptide of SEQ ID NO:2 is detected by an immunological method or a hybridization method. 
     
     
       7. The method of  claim 6 , wherein the immunological method is immunohistochemical staining or ELISA. 
     
     
       8. The method of  claim 7 , wherein the immunological method is ELISA. 
     
     
       9. The method of  claim 6 , wherein the hybridization method is selected from the group consisting of Southern blotting, northern blotting, dot blotting, polymerase chain reaction (PCR), microarray analysis and in situ hybridization. 
     
     
       10. The method of  claim 9 , wherein the hybridization method is microarray analysis. 
     
     
       11. The method of  claim 1 , wherein the inflammatory bowel disease is ulcerative colitis. 
     
     
       12. A method of diagnosing an immune related disease in a mammal, wherein the immune related disease is psoriasis or inflammatory bowel disease, said method comprising the steps of:
 (a) contacting an antibody that specifically binds to a polypeptide comprising the amino acid sequence of SEQ ID NO:2, or fragments thereof, with a test sample of tissue cells obtained from said mammal,   (b) contacting the antibody with a control sample of known normal tissue cells of the same cell type,   (c) detecting the formation of a complex between the antibody and the polypeptide in the test sample and in the control sample, and   (d) diagnosing the immune related disease in the mammal from which the test sample of tissue cells were obtained when the quantity of complexes formed in the test sample is larger as compared to the quantity of complexes formed in the control sample.   
     
     
       13. The method of  claim 12 , wherein the immune related disease is psoriasis. 
     
     
       14. The method of  claim 12 , wherein the immune related disease is inflammatory bowel disease. 
     
     
       15. The method of  claim 12 , wherein the formation of a complex between the antibody and the polypeptide is detected by immunohistochemical staining or ELISA. 
     
     
       16. The method of  claim 15 , wherein the formation of a complex between the antibody and the polypeptide is detected by ELISA. 
     
     
       17. The method of  claim 12 , wherein the inflammatory bowel disease is ulcerative colitis. 
     
     
       18. A method of diagnosing and treating an immune related disease in a human, wherein the immune related disease is cancer, said method comprising the steps of:
 (1) detecting the level of expression of a gene encoding the polypeptide of SEQ ID NO: 2 in a test sample of tissue cells obtained from the human,   (2) detecting the level of expression of the gene encoding the polypeptide of SEQ ID NO: 2 in a control sample of known normal tissue cells of the same cell type,   (3) diagnosing the immune related disease in the human when the level of expression of said gene in the test sample is higher as compared to the level of expression of said gene in the control sample, and   (4) administering to the human a therapeutically effective amount of an antagonist of the polypeptide of SEQ ID NO: 2, wherein the antagonist is an antibody or antigen-binding fragment thereof.   
     
     
       19. The method of claim 18, wherein the human is diagnosed with the immune related disease when the level of expression of said gene is at least 2 fold greater in the test sample as compared to the level of expression of said gene in the control sample. 
     
     
       20. The method of claim 18, wherein the level of expression of the gene encoding the polypeptide of SEQ ID NO: 2 is detected by an immunological method or a hybridization method. 
     
     
       21. The method of claim 20, wherein the immunological method is immunohistochemical staining or ELISA. 
     
     
       22. The method of claim 21, wherein the immunological method is ELISA. 
     
     
       23. The method of claim 20, wherein the hybridization method is selected from the group consisting of Southern blotting, northern blotting, dot blotting, polymerase chain reaction (PCR), microarray analysis, and in situ hybridization. 
     
     
       24. The method of claim 23, wherein the hybridization method is microarray analysis. 
     
     
       25. A method of diagnosing and treating an immune related disease in a human, wherein the immune related disease is cancer, said method comprising the steps of:
 (a) contacting an antibody that specifically binds to a polypeptide comprising the amino acid sequence of SEQ ID NO: 2, or fragments thereof, with a test sample of tissue cells obtained from said human,   (b) contacting the antibody with a control sample of known normal tissue cells of the same cell type,   (c) detecting the formation of a complex between the antibody and the polypeptide in the test sample and in the control sample,   (d) diagnosing the immune related disease in the human from which the test sample of tissue cells were obtained when the quantity of complexes formed in the test sample is larger as compared to the quantity of complexes formed in the control sample, and   (e) administering to the human a therapeutically effective amount of an antagonist of the polypeptide of SEQ ID NO: 2, wherein the antagonist is an antibody or antigen-binding fragment thereof.   
     
     
       26. The method of claim 25, wherein the formation of a complex between the antibody and the polypeptide is detected by immunohistochemical staining or ELISA. 
     
     
       27. The method of claim 26, wherein the formation of a complex between the antibody and the polypeptide is detected by ELISA. 
     
     
       28. The method of claim 18 or 25, wherein the antibody or antigen-binding fragment thereof is human. 
     
     
       29. The method of claim 18 or 25, wherein the antibody or antigen-binding fragment thereof is humanized. 
     
     
       30. The method of claim 18 or 25, wherein the antibody or antigen-binding fragment thereof is monoclonal, chimeric, bispecific, monovalent, bivalent, or single chain. 
     
     
       31. The method of claim 18 or 25, wherein the antibody or antigen-binding fragment thereof is in a heteroconjugate or an immunoconjugate. 
     
     
       32. The method of claim 18 or 25, comprising administering the antagonist of the polypeptide of SEQ ID NO: 2 in combination with an anti-cancer therapeutic regimen. 
     
     
       33. The method of claim 32, wherein the anti-cancer therapeutic regimen comprises administering an antibody. 
     
     
       34. The method of claim 33, wherein the antibody binds to CD20, CD11a, CD18, ErbB2, EGFR, ErbB3, ErbB4, or VEGF. 
     
     
       35. The method of claim 32, wherein the anti-cancer therapeutic regimen comprises administering a growth regulating agent, a cytotoxic agent, or a chemotherapeutic agent. 
     
     
       36. The method of claim 32, wherein the anti-cancer therapeutic regimen comprises administering radiation therapy. 
     
     
       37. The method of claim 18 or 25, wherein the antagonist of the polypeptide of SEQ ID NO: 2 is administered in an amount sufficient to stimulate the immune response.

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