Claims for Patent: 7,943,310

Summary for Patent: 7,943,310

Title:	Methods for assessing response to therapy in subjects having ulcerative colitis
Abstract:	A method for prognostic or diagnostic assessment of a gastrointestinal-related disorder, such as ulcerative colitis, in a subject correlates the presence, absence, and/or magnitude of a gene in a sample with a reference standard to determine the presence and/or severity of the disorder, and/or the response to treatment for the disorder. The method enables identification of the effectiveness of candidate therapies.
Inventor(s):	Li; Xilin (Wallingford, PA), Song; Xiao-yu (Bridgewater, NJ)
Assignee:	Centocor Ortho Biotech Inc. (Horsham, PA)
Application Number:	11/847,812
Patent Claims:	1. A method for determining the likelihood that a human subject with ulcerative colitis will respond to an anti-TNF.alpha. therapy, comprising: a) preparing a sample of mRNA from a specimen obtained from a colon biopsy of a human subject with ulcerative colitis treated with the anti-TNF.alpha. therapy; b) contacting the sample with a panel of nucleic acid probes that hybridize to the nucleic acid sequences of SEQ ID NOS: 8, 9, 28, 37, and 66; c) hybridizing the sample with the panel of nucleic probes to detect levels of the mRNAs in the sample encoded by the nucleic acid sequences of SEQ ID NOS: 8, 9, 28, 37, and 66; d) comparing the levels of the mRNAs in the sample encoded by the nucleic acid sequences of SEQ ID NOS: 8, 9, 28, 37, and 66 against a reference standard of mRNAs encoded by nucleic acid sequences of SEQ ID NOS: 8, 9, 28, 37, and 66; and e) determining the likelihood that the human subject will respond to the anti-TNF.alpha. therapy based on the comparison in step d). 2. The method of claim 1, wherein the anti-TNF.alpha. therapy is an anti-TNF.alpha. antibody. 3. The method of claim 2, wherein the anti-TNF.alpha. antibody is infliximab. 4. The method of claim 1, wherein the determining step comprises performing a statistical comparison of the levels of the mRNAs in the sample from the subject to a reference standard to determine the likelihood that the subject will respond to the anti-TNF.alpha. therapy. 5. The method of claim 1, wherein the levels of the mRNAs in the sample are determined using RT-PCR. 6. The method of claim 1, wherein the specimen is obtained from the subject about 8 weeks after commencement of treatment with the anti-TNF.alpha. therapy. 7. The method of claim 6, wherein the anti-TNF.alpha. therapy is infliximab. 8. The method of claim 1, wherein the specimen is obtained from the subject about 30 weeks after commencement of treatment with the anti-TNF.alpha. therapy. 9. The method of claim 8, wherein the anti-TNF.alpha. therapy is infliximab. 10. The method of claim 1, wherein the determining step further comprises determining the likelihood that the subject will respond to the anti-TNF.alpha. therapy if there is about a two fold change in the levels of mRNAs in the sample encoded by the nucleic acid sequences of SEQ ID NOS: 8, 9, 28, 37, and 66 as compared to the reference standard of mRNAs encoded by the nucleic acid sequences of SEQ ID NO: 8, 9, 28, 37 and 66. 11. The method of claim 1, further comprising the step of continuing treatment with the anti-TNF.alpha. therapy if the subject is determined likely to respond to the therapy. 12. The method of claim 1, further comprising the step of discontinuing treatment with the anti-TNF.alpha. therapy if the subject is determined not likely to respond to the therapy.

Details for Patent 7,943,310

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2039-02-26