IP Library Granted Patent US 11,065,351
Granted Patent B2
US 11,065,351 · App. 16/502,328 · Granted Jul 20, 2021

Methods for diagnosing and monitoring eosinophilic esophagitis

Inventors: Leonard F. Pease (Bountiful, UT); Hedieh Saffari (Salt Lake City, UT); Gerald J. Gleich (Salt Lake City, UT); Kristin M. Leiferman (Salt Lake City, UT); Kathryn A. Peterson (Salt Lake City, UT); Russell Morris Condie (Salt Lake City, UT)
Assignee: University of Utah Research Foundation
A61K51/0491A61K51/08
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Quick Facts
Patent No.
US 11,065,351
App. No.
16/502,328
Granted
Jul 20, 2021
Kind
B2
Abstract

Disclosed are compositions and methods for diagnosing eosinophilic esophagitis in a subject. Also disclosed are methods for monitoring the course of eosinophilic esophagitis in a subject before, during, and after treatment. In another aspect, disclosed is a method of diagnosing eosinophilic esophagitis or eosinophilic diseases in a subject, comprising detecting an eosinophil granule protein in the mucosal tissue of the esophagus or other organs in a subject.

Claims (35)

1. A method of producing a medical image of an esophagus of a subject, the method comprising:

orally administering radiolabeled heparin to the subject, wherein the radiolabeled heparin binds to one or more eosinophil granule proteins in the mucosal tissue of the esophagus; and

detecting the radiolabeled heparin to produce a medical image of the esophagus comprising one or more of a furrow, a ring, and a stricture along the esophagus.

2. The method of claim 1 , wherein the binding generates a radiolabeled heparin eosinophil granule protein complex and detecting the radiolabeled heparin comprises detecting the radiolabeled heparin eosinophil granule protein complex.

3. The method of claim 1 , wherein the one or more eosinophil granule proteins comprise one or more of major basic protein 1 (MBP-1), major basic protein 2 (MBP-2), eosinophil derived neurotoxin (EDN), eosinophil cationic protein (ECP), and eosinophil peroxidase (EPO).

4. The method of claim 1 , wherein the radiolabel is 99m Tc.

5. The method of claim 1 , wherein the radiolabeled heparin is orally administered during the detection of the radiolabeled heparin.

6. The method of claim 1 , wherein a density of the radiolabeled heparin in the medical image is indicative of a degree of inflammation in the mucosal tissue.

7. The method of claim 1 , wherein detecting the radiolabeled heparin comprises detecting by single-photon emission computed tomography (SPECT), positron emission tomography (PET), X-ray, conventional or computed tomography (CT), magnetic resonance imaging (MRI), or combinations thereof.

8. A method of detecting a structural narrowing along an esophagus of a subject, wherein the structural narrowing comprises one or more of a furrow, a ring and a stricture, the method comprising:

producing a first medical image according to the method of claim 1 ;

producing a second medical image according to the method of claim 1 ; and

comparing the second medical image with the first medical image, whereby detecting a change therebetween detects a structural narrowing along the esophagus of the subject.

9. The method of claim 8 , further comprising administering a suspected allergen to the subject prior to producing the second medical image, wherein the suspected allergen is selected from the group consisting of a food allergen and an aero-allergen.

10. The method of claim 8 , further comprising administering a treatment of eosinophilic esophagitis to the subject prior to producing the second medical image.

11. A method of producing a medical image of a gastrointestinal tract of a subject, the method comprising:

orally administering radiolabeled heparin to the subject, wherein the radiolabeled heparin binds to one or more eosinophil granule proteins in the mucosal tissue of the gastrointestinal tract; and

detecting the radiolabeled heparin to produce a medical image of the gastrointestinal tract comprising a structural narrowing along the gastrointestinal tract.

12. The method of claim 11 , wherein the structural narrowing comprises one or more of a furrow, a ring, and a stricture.

13. The method of claim 11 , wherein the binding generates a radiolabeled heparin eosinophil granule protein complex and detecting the radiolabeled heparin comprises detecting the radiolabeled heparin eosinophil granule protein complex.

14. The method of claim 11 , wherein the one or more eosinophil granule proteins comprise one or more of major basic protein 1 (MBP-1), major basic protein 2 (MBP-2), eosinophil derived neurotoxin (EDN), eosinophil cationic protein (ECP), and eosinophil peroxidase (EPO).

15. The method of claim 11 , wherein the radiolabel is 99m Tc.

16. The method of claim 11 , wherein the radiolabeled heparin is orally administered during the detection of the radiolabeled heparin.

17. The method of claim 11 , wherein a density of the radiolabeled heparin in the medical image is indicative of a degree of inflammation in the mucosal tissue.

18. The method of claim 11 , wherein the gastrointestinal tract includes the esophagus.

19. The method of claim 11 , wherein the gastrointestinal tract includes one or more of a stomach, a proximal large intestine, a distal large intestine, and a small intestine of the subject.

20. A method of diagnosing one or more of a furrow, a ring and a stricture in an esophagus of a subject, the method comprising:

orally administering radiolabeled heparin to the subject, wherein the radiolabeled heparin binds to one or more eosinophil granule proteins in the mucosal tissue of one or more of a furrow, a ring and a stricture in the esophagus; and

detecting the radiolabeled heparin in the mucosal tissue of one or more of a furrow, a ring and a stricture in the esophagus, whereby detecting the radiolabeled heparin in the mucosal tissue of one or more of a furrow, a ring and a stricture in the esophagus diagnoses one or more of a furrow, a ring and a stricture in the esophagus of the subject.

21. The method of claim 20 , wherein the binding generates a radiolabeled heparin eosinophil granule protein complex and detecting the radiolabeled heparin comprises detecting the radiolabeled heparin eosinophil granule protein complex.

22. The method of claim 20 , wherein the one or more eosinophil granule proteins comprise one or more of major basic protein 1 (MBP-1), major basic protein 2 (MBP-2), eosinophil derived neurotoxin (EDN), eosinophil cationic protein (ECP), and eosinophil peroxidase (EPO).

23. The method of claim 20 , wherein the radiolabel is 99m Tc.

24. The method of claim 20 , wherein the radiolabeled heparin is orally administered during the detection of the radiolabeled heparin.

25. The method of claim 20 , wherein detecting the radiolabeled heparin comprises detecting by single-photon emission computed tomography (SPECT), positron emission tomography (PET), X-ray, conventional or computed tomography (CT), magnetic resonance imaging (MRI), or combinations thereof.

26. The method of claim 20 , wherein the subject is a human.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 26, 2021
From: SAFFARI, HEDIEH; GLEICH, GERALD J.; LEIFERMAN, KRISTIN M.; PETERSON, KATHRYN A.; CONDIE, RUSSELL MORRIS
To: UNIVERSITY OF UTAH
Reel/Frame 057293/0472 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 22, 2021
From: PEASE, LEONARD F.; SAFFARI, HEDIEH; GLEICH, GERALD J.; LEIFERMAN, KRISTIN M.; PETERSON, KATHRYN A.; CONDIE, RUSSELL MORRIS
To: UNIVERSITY OF UTAH
Reel/Frame 056949/0880 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 22, 2021
From: UNIVERSITY OF UTAH
To: UNIVERSITY OF UTAH RESEARCH FOUNDATION
Reel/Frame 056949/0933 →
Continuity (5)
Continuation 15719827 · Sep 29, 2017
Continuation 14402070
Provisional Application 61786909 · Mar 15, 2013
Provisional Application 61688650 · May 18, 2012
Related Publication 20200016282A1 · Jan 16, 2020