IP Library Granted Patent US 10,471,080
Granted Patent B2
US 10,471,080 · App. 13/901,784 · Granted Nov 12, 2019

Use of trehalose for prevention of neural tube defects

Inventors: Peixin Yang (Woodstock, MD); E. Albert Reece (Lutherville, MD)
Assignee: UNIVERSITY OF MARYLAND, BALTIMORE
A61K31/7016A46B15/0093A46B2200/1046
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Quick Facts
Patent No.
US 10,471,080
App. No.
13/901,784
Granted
Nov 12, 2019
Kind
B2
Abstract

Maternal diabetes suppresses autophagy in neuroepithelial cells of the developing neural tube which leads to neural tube defect formation. Trehalose treatment reversed autophagy impairment and prevented neural tube defects in diabetic pregnancies. Trehalose resolved homeostatic imbalance by correcting mitochondrial defects, dysfunctional proteins, ER stress, apoptosis, and delayed neurogenesis in the neural tubes exposed to hyperglycemia. Methods of using trehalose as an intervention against hyperglycemia-induced neural tube defects are provided herein.

Claims (10)

1. A method for reducing the risk of a hyperglycemia-induced neural tube defect in an embryo, comprising administering a therapeutically-effective amount of a pharmaceutical formulation consisting of trehalose-in-water to a pregnant subject or a subject intending to become pregnant, wherein the subject is hyperglycemic, wherein the therapeutically-effective amount of the formulation is an amount that achieves between about 260 and 500 ug/ml trehalose in the maternal blood, wherein when the subject is pregnant, the therapeutically-effective amount of the formulation is administered daily through the first month of pregnancy, and wherein when the subject is intending to become pregnant,the therapeutically-effective amount of the formulation is administered daily from a few days before the date on which conception is attempted through the first month of pregnancy.

2. The method of claim 1 , wherein the hyperglycemia is diabetes mellitus-induced hyperglycemia, drug-induced hyperglycemia, or illness-induced hyperglycemia.

3. The method of claim 1 , wherein the neural tube defect is failure of neural tube closure.

4. The method of claim 1 , wherein the therapeutically-effective amount of the formulation is an amount that achieves about 350 ug/ml trehalose in the maternal blood.

5. The method of claim 1 , wherein the therapeutically-effective amount of the formulation is administered to the subject orally or via parenteral administration.

6. A method for preventing a hyperglycemia-induced neural tube defect in an embryo, comprising administering a therapeutically-effective amount of a pharmaceutical formulation consisting of trehalose-in-water to a pregnant subject or a subject intending to become pregnant, wherein the subject is hyperglycemic, wherein the therapeutically-effective amount of the formulation is an amount that achieves between about 260 and 500 ug/ml trehalose in the maternal blood, wherein when the subject is pregnant, the therapeutically-effective amount of the formulation is administered daily through the first month of pregnancy, and wherein when the subject is intending to become pregnant, the therapeutically-effective amount of the formulation is administered daily from a few days before the date on which conception is attempted through the first month of pregnancy.

7. The method of claim 6 , wherein the hyperglycemia is diabetes mellitus-induced hyperglycemia, drug-induced hyperglycemia, or illness-induced hyperglycemia.

8. The method of claim 6 , wherein the neural tube defect is failure of neural tube closure.

9. The method of claim 6 , wherein the therapeutically-effective amount of the formulation is an amount that achieves about 350 ug/ml trehalose in the maternal blood.

10. The method of claim 6 , wherein the therapeutically-effective amount of the formulation is administered to the subject orally or via parenteral administration.

Assignments (2)
CONFIRMATORY LICENSE Recorded May 29, 2013
From: THE UNIVERSITY OF MARYLAND, BALTIMORE
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 030501/0775 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2013
From: YANG, PEIXIN; REECE, E. ALBERT
To: UNIVERSITY OF MARYLAND, BALTIMORE
Reel/Frame 030481/0275 →
Continuity (2)
Provisional Application 61651189 · May 24, 2012
Related Publication 20130316971A1 · Nov 28, 2013