Claims for Patent: 9,651,562

Summary for Patent: 9,651,562

Title:	Cathelicidin as novel inflammatory bowel disease marker and therapy for colitis associated intestinal fibrosis
Abstract:	Method of diagnosing and treating inflammatory bowel disease are disclosed herein. Inflammatory bowel disease can be treated and diagnosed using cathelicidin peptides and detection agents thereof. Specifically, method of treating and diagnosing Crohn\'s disease and ulcerative colitis are disclosed herein.
Inventor(s):	Koon; Hon Wai (Los Angeles, CA), Pothoulakis; Charalabos (Los Angeles, CA)
Assignee:	THE REGENTS OF THE UNIVERSITY OF CALIFORNIA (Oakland, CA)
Application Number:	14/648,207
Patent Claims:	1. A method of determining inflammatory bowel disease activity in a subject, the method comprising: (a) contacting a biological sample obtained from the subject with an antibody that Specifically binds cathelicidin; (b) detecting the binding of antibody to cathelicidin in (a), thereby measuring cathelicidin protein level; (c) determining inflammatory bowel disease activity level in the subject when the cathelicidin protein level is lower than 35 pg/.mu.g protein or lower than 40 ng/ml plasma; and (d) treating the patient with an immunosuppressant or anti-inflammatory agent effective against inflammatory bowel disease in accordance with the inflammatory bowel disease activity level determined in step (c). 2. The method of claim 1, wherein the biological sample is a colonic sample. 3. The method of claim 1, wherein the sample is a blood sample, serum sample, plasma sample, fecal sample, or intestinal sample. 4. The method of claim 1, wherein the sample is a colonic biopsy. 5. The method of claim 1, wherein the cathelicidin protein is LL-37 peptide. 6. The method of claim 1, wherein the subject is human. 7. The method of claim 1, wherein the subject has Crohn's Disease. 8. The method of claim 1, wherein the subject has Ulcerative Colitis. 9. The method of claim 1, wherein the determining of step (c) further comprises determining inflammatory bowel disease activity when an increased level of C-reactive protein (CRP) or an increased level of erythrocyte sedimentation rate (ESR) is detected. 10. A method for treating a patient who has high inflammatory bowel disease activity, the method comprising: (a) providing a biological sample from a patient; (b) applying the biological sample to a solid support mechanism; and (c) assaying the biological sample on the solid support mechanism to detect a level of cathelicidin peptide; wherein the patient is administered a pharmaceutical composition comprising an amount of an immunosuppressant or anti-inflammatory agent sufficient to effect a positive therapeutic response against inflammatory bowel disease in accordance with the level of cathelicidin detected, wherein the positive therapeutic response is a protein level higher than 35 pg/.mu.g protein or 40 ng/ml plasma. 11. The method of claim 10, wherein the biological sample is a colonic sample. 12. The method of claim 10, wherein the sample is a blood sample, serum sample, plasma sample, fecal sample, or intestinal sample. 13. The method of claim 10, wherein the sample is a colonic biopsy. 14. The method of claim 10, wherein the cathelicidin peptide is LL-37. 15. The method of claim 10, wherein the patient is human. 16. The method of claim 10, wherein the patient has Crohn's Disease. 17. The method of claim 10, wherein the patient has Ulcerative Colitis. 18. The method of claim 10, wherein the anti-inflammatory agent comprises an anti-TNF.alpha. agent. 19. The method of claim 10, wherein the assaying is performed using an ELISA. 20. The method of claim 10, wherein the assaying is performed using FACS, Western blot, immunohistochemistry, or RT-PCR. 21. The method of claim 10, wherein the cathelicidin level is less than 20 pg/.mu.g protein. 22. The method of claim 10, further comprising assaying the sample for C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), wherein a low concentration of cathelicidin protein is correlated with increased CRP or ESR. 23. The method of claim 10, wherein the positive therapeutic response is a cathelicidin protein level higher than 35 pg/.mu.g protein or 40 ng/ml plasma. 24. A method for determining the likelihood of a patient who previously suffered from inflammatory bowel disease to relapse, the method comprising detecting cathelicidin protein levels in a sample obtained from the patient, wherein levels of cathelicidin protein higher than 35 pg/.mu.g protein or 40 ng/ml in plasma are predictive of a longer disease free period, and administering or adjusting an immunosuppressant or anti-inflammatory treatment effective against inflammatory bowel disease to the patient in accordance with the level of cathelicidin. 25. The method of claim 24, further comprising assaying the sample for CRP, wherein low levels of CRP are further predictive of a longer disease free period. 26. The method of claim 1, wherein steps (c) and (d) are repeated after the subject has been treated for inflammatory bowel disease and wherein the treating of repeated step (d) comprises adjusting the amount of immunosuppressant or anti-inflammatory agent with which the subject is treated. 27. The method of claim 1, wherein the anti-inflammatory agent is an anti-TNF.alpha. agent. 28. The method of claim 10, wherein the immunosuppressant is methotrexate or an equivalent thereof. 29. The method of claim 10, wherein the immunosuppressant is natalizumab or an equivalent thereof. 30. A method of determining inflammatory bowel disease activity in a subject, the method comprising: (a) contacting a biological sample obtained from the subject with an antibody that specifically binds CRP; (b) detecting the binding of antibody to CRP in (a), thereby measuring a CRP level; (c) contacting a biological sample obtained from the subject with an antibody that specifically binds cathelicidin; (d) detecting the binding of antibody to cathelicidin in (c), thereby measuring a cathelicidin level; (e) administering or adjusting treatment for inflammatory bowel disease activity level in the subject with an immunosuppressant or anti-inflammatory agent effective against inflammatory bowel disease in accordance with the cathelicidin level determined in step (d); wherein a cathelicidin level higher than 35 pg/.mu.g protein or 40 ng/ml plasma is associated with inflammatory bowel disease.

Details for Patent 9,651,562

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2032-12-10