IP Library Granted Patent US 12,313,635
Granted Patent B2
US 12,313,635 · App. 17/263,762 · Granted May 27, 2025

Biomarker for thoracic aortic aneurysm

Inventor: Hua Cai (Los Angeles, CA)
Assignee: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
G01N33/6893A61K31/519A61P9/00G01N2800/329G01N2800/52
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Quick Facts
Patent No.
US 12,313,635
App. No.
17/263,762
Granted
May 27, 2025
Kind
B2
Abstract

A method for detecting thoracic aortic aneurysm (TAA) or predisposition to TAA in a subject comprises measuring the amount of tetrahydrobiopterin (H 4 B) present in the test sample; and comparing a measured amount of HUB to a standard amount of H 4 B. A decreased amount of H 4 B present in the test sample compared to the standard is indicative of TAA or predisposition to TAA. The method can further comprise identifying a candidate for further testing or monitoring for TAA, such as by ultrasound or by repeated testing for H 4 B after one or more designated intervals. The method can also further comprise prescribing treatment for TAA to the subject, such as with folic acid therapy, and/or DHFR therapy, including gene therapy, and other therapies effective for recoupling eNOS and/or therapies targeting uncoupled eNOS. Methods are also described for monitoring the efficacy of treatment of TAA, and for evaluating the severity of TAA or risk of TAA.

Claims (18)

1. A method for treating thoracic aortic aneurysm (TAA) in a subject having TAA, the method comprising:

(a) measuring, in a test sample of serum, plasma or whole blood from the subject, the amount of tetrahydrobiopterin (H 4 B) present in the test sample; wherein a decrease is detected in the measured amount of H 4 B present in the test sample relative to a standard amount of H 4 B; and

(b) treating the subject with oral administration of folic acid or dihydrofolate reductase (DHFR) gene therapy.

2. The method of claim 1 , wherein the decrease is a 30% decrease in the amount of H 4 B present in the test sample compared to the standard.

3. The method of claim 1 , wherein the decrease is a 40% decrease in the amount of H 4 B present in the test sample compared to the standard.

4. The method of claim 1 , wherein the decrease is a 50% decrease in the amount of H 4 B present in the test sample compared to the standard.

5. The method of claim 1 , wherein the measuring comprises an immunoassay or a chemiluminescence assay.

6. The method of claim 1 , wherein the measuring comprises high performance liquid chromatography (HPLC).

7. The method of claim 1 , wherein the treating comprises oral administration of folic acid.

8. The method of claim 1 , wherein the decrease is a 20% decrease in the amount of H 4 B present in the test sample compared to the standard.

9. The method of claim 1 , wherein the sample is plasma.

10. The method of claim 1 , further comprising measuring, in a second test sample of serum, plasma or whole blood obtained from the subject at a second time point, the amount of H 4 B present in the second test sample; wherein treatment with folic acid therapy is administered to the subject prior to the second time point.

11. The method of claim 10 , wherein a 20% increase is measured in the amount of H 4 B present in the second test sample compared to the amount of H 4 B measuring in step (a).

12. The method of claim 10 , further comprising prescribing a modified treatment for TAA to the subject whose H 4 B is decreased in the second test sample compared to the amount measured in step (a).

13. The method of claim 1 , further comprising prescribing a modified treatment for TAA to the subject whose H 4 B is insufficiently increased in the second test sample compared to the amount measured in step (a).

14. The method of claim 1 , wherein the decrease is a 60% decrease in the amount of H 4 B present in the test sample compared to the standard.

15. The method of claim 1 , wherein the decrease is a 70% decrease in the amount of H 4 B present in the test sample compared to the standard.

16. The method of claim 1 , wherein the decrease is a 80% decrease in the amount of H 4 B present in the test sample compared to the standard.

Assignments (2)
CONFIRMATORY LICENSE Recorded Nov 15, 2023
From: UNIVERSITY OF CALIFORNIA LOS ANGELES
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 065593/0749 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2021
From: CAI, HUA
To: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
Reel/Frame 055875/0518 →
Continuity (2)
Provisional Application 62711348 · Jul 27, 2018
Related Publication 20210302438A1 · Sep 30, 2021
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