Compositions and methods useful for the treatment and diagnosis of inflammatory bowel disease

• US 9,279,158 B2
• Filed: 03/27/2013
• Issued: 03/08/2016
• Est. Priority Date: 09/27/2010
• Status: Active Grant

• Current Assignee: Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Foundation)
• Original Assignee: Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Foundation)
• Inventors: Friedman, Joshua R., Zahm, Adam, Thayu, Meena, Hand, Nicholas, deZoeten, Edwin
• Primary Examiner(s): Leith, Nancy J
• Application Number:
  US13/851,623
• Publication Number:
  US 20130225440A1
• Time in Patent Office: 1,077 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/136 Screening for pharmacological compounds
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: C12Q 2600/178 miRNA, siRNA or ncRNA

Abstract

Compositions and methods useful for the diagnosis and treatment of IBD including Crohn'"'"'s disease are disclosed.

Claims

1. A kit for practicing a method of determining response to therapy in a human subject having Inflammatory Bowel Disease (IBD) that includes measuring in a serum sample from the subject the level of at least one differentially expressed miRNA, wherein the differentially expressed miRNA comprises miR-484 having a serum miRNA significance threshold of p<

0.05,

said kit comprising an oligonucleotide that specifically hybridizes to at least one differentially expressed miRNA, said oligonucleotide being (i) immobilized on a solid support or (ii) detectably labeled, and one or more of a physiologically acceptable carrier, instructions for use, a container for serum, and an assay substrate;

wherein said at least one differentially expressed miRNA comprises miR-484.

2. The kit of claim 1, wherein said kit comprises an internal reference miRNA that is one or both of miR-150 and miR-342-3p.

3. The kit of claim 1, wherein the differentially expressed miRNA comprises at least two miRNA selected from the group consisting of miR-195, miR-16, miR-93, miR-140, miR-30e, miR-20a, miR-106a, miR-192, let-7b, miR-21, and miR-484.

4. The kit of claim 1, wherein the differentially expressed miRNA comprises at least five miRNA selected from the group consisting of miR-195, miR-16, miR-93, miR-140, miR-30e, miR-20a, miR-106a, miR-192, let-7b, miR-21, and miR-484.

5. The kit of claim 1, wherein the differentially expressed miRNA comprises at least ten miRNA selected from the group consisting of miR-195, miR-16, miR-93, miR-140, miR-30e, miR-20a, miR-106a, miR-192, let-7b, miR-21, and miR-484.

6. The kit of claim 1, wherein the differentially expressed miRNA comprises miR-195, miR-16, miR-93, miR-140, miR-30e, miR-20a, miR-106a, miR-192, let-7b, miR-21, and miR-484.