IP Library Granted Patent US 12,083,123
Granted Patent B2
US 12,083,123 · App. 17/494,968 · Granted Sep 10, 2024

Method for the detection of drug-induced organ or tissue injury in IMPDH inhibitor treated patients

Inventors: Atsuo Sasaki (Cincinnati, OH); Mikako Warren (Pasadena, CA)
A61K31/5377A61P1/16G01N33/5008
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Quick Facts
Patent No.
US 12,083,123
App. No.
17/494,968
Granted
Sep 10, 2024
Kind
B2
Abstract

The present disclosure concerns methods of detecting injury to a tissue and/or organ in a subject. In some aspects, the subject is the recipient of a transplant, such as a liver transplant. In some aspects, the subject is undergoing treatment with an immunosuppressant. In some aspects, the present disclosure concerns the identification of aberrant mitochondria in the subject to identify injury to the tissue and/or organ of the subject. Detecting aberrant mitochondria allows for remedial and/or corrective action to prevent or avoid significant injury.

Claims (16)

1. A method for detecting injury to a tissue in a subject undergoing a drug regimen for tissue or organ transplantation, comprising:

obtaining a tissue or organ sample from a transplanted tissue or organ in a subject at a first time point;

determining the presence of aberrant mitochondria in the tissue or organ sample, wherein the aberrant mitochondria in the tissue or organ sample signify injury to the transplanted tissue or organ; and,

taking remedial action to prevent further injury to the transplanted tissue or organ.

2. The method of claim 1 , further comprising determining the presence of aberrant nuclei in the tissue or organ sample.

3. The method of claim 1 , further comprising determining the presence of IMPDH2 (inosine monophosphate dehydrogenase 2) and/or guanosine monophosphate synthetase (GMPS) in the tissue or organ sample.

4. The method of claim 1 , further comprising determining lysosomal activity in cells of the tissue or organ sample.

5. The method of claim 1 , wherein the tissue or organ sample is a liver or kidney sample.

6. The method of claim 1 , wherein the subject is a liver transplant recipient.

7. The method of claim 1 , wherein the drug regimen comprises treatment with an IMPDH inhibitor.

8. The method of claim 7 , wherein the IMPDH inhibitor is selected from the group consisting of mycophenolate mofetil (MMF), mycophenolic acid (MPA), tiazofurin, ribavirin, VX-944, or FF-10501.

9. The method of claim 1 , wherein the remedial action is to cease the drug regimen.

10. The method of claim 1 , wherein the remedial action is changing to a different drug.

11. The method of claim 10 , wherein the subject is changed to a drug regimen of one of prednisone, tacrolimus, sirolimus, everolimus, azathioprine, leflunomide, prednisolone, budesonide, and/or cyclosporine.

12. The method of claim 1 , further comprising obtaining a second tissue or organ sample from the transplanted tissue or organ in the subject at a second time point different from the first time point.

13. The method of claim 1 , wherein the transplanted organ or tissue is liver and wherein the subject is undergoing a treatment regimen with mycophenolate mofetil (MMF) or mycophenolic acid (MPA).

Assignments (3)
CONFIRMATORY LICENSE Recorded Dec 13, 2023
From: UNIVERSITY OF CINCINNATI
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 065858/0521 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 6, 2021
From: WARREN, MIKAKO
To: CHILDREN'S HOSPITAL LOS ANGELES
Reel/Frame 057717/0879 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 6, 2021
From: SASAKI, ATSUO
To: UNIVERSITY OF CINCINNATI
Reel/Frame 057717/0963 →
Continuity (2)
Provisional Application 63088106 · Oct 6, 2020
Related Publication 20220105099A1 · Apr 7, 2022