US2014348872A1PendingUtilityA1

Compositions and methods for establishing and/or maintaining pregnancy

58
Assignee: ALLTECH INCPriority: May 18, 2007Filed: Aug 11, 2014Published: Nov 27, 2014
Est. expiryMay 18, 2027(~0.8 yrs left)· nominal 20-yr term from priority
A61K 36/06A61K 33/04A61P 15/00A61K 36/064A61K 48/00
58
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Claims

Abstract

The present invention relates to compositions comprising selenium (e.g., organic selenium (e.g., selenized yeast (e.g., SEL-PLEX))) and methods of using the same (e.g., as a therapeutic and/or prophylactic treatment). For example, the present invention provides compositions comprising selenium (e.g., organic selenium (e.g., selenized yeast (e.g., SEL-PLEX))) and methods of using the same for treating and/or preventing one or more conditions (e.g., problems) disorders, and/or diseases related to establishing and/or maintaining a pregnancy. Compositions and methods of the present invention find use in, among other things, research and clinical (e.g., preventative and therapeutic) applications.

Claims

exact text as granted — not AI-modified
1 . A method of altering expression of one or more genes associated with establishment of and/or maintenance of pregnancy in a subject comprising:
 administering an effective amount of a composition comprising a dried, nonviable selenium-enriched yeast to the subject wherein the effective amount enhances the expression of one or more genes associated with establishment of and/or maintenance of pregnancy in the subject compared to a control subject.   
     
     
         2 . The method of  claim 1 , wherein the control subject is not administered selenium. 
     
     
         3 . The method of  claim 1 , wherein the control subject is administered a composition comprising selenium, wherein the selenium is not present in a dried, nonviable selenium enriched yeast. 
     
     
         4 . The method of  claim 1 , wherein the one or more genes associated with establishment of and/or maintenance of pregnancy is serum and glucocorticoid inducible-protein kinase (sgk). 
     
     
         5 . The method of  claim 1 , wherein enhancing expression of one or more genes associated with establishment of and/or maintenance of pregnancy reduces and/or eliminates the risk of perinatal morbidity and/or mortality in the subject. 
     
     
         6 . The method of  claim 1 , wherein enhancing expression of one or more genes associated with establishment of and/or maintenance of pregnancy increases fetal growth in the subject. 
     
     
         7 . The method of  claim 7 , wherein increasing fetal growth in said subject comprises increasing fetal growth rate in said subject. 
     
     
         8 . The method of  claim 1 , wherein enhancing expression of one or more genes associated with establishment of and/or maintenance of pregnancy increases the duration of gestation in said subject. 
     
     
         9 . The method of  claim 1 , wherein enhancing expression of one or more genes associated with establishment of and/or maintenance of pregnancy promotes the health of the uterus. 
     
     
         10 . The method of  claim 10 , wherein promoting the health of the uterus comprises promoting connective tissue formation and/or rearrangement. 
     
     
         11 . The method of  claim 1 , wherein enhancing expression of one or more genes associated with establishment of and/or maintenance of pregnancy promotes proper formation of the pubis. 
     
     
         12 . The method of  claim 1 , wherein enhancing expression of one or more genes associated with establishment of and/or maintenance of pregnancy promotes the health of the embryo and/or fetus in said subject. 
     
     
         13 . The method of  claim 13 , wherein promoting the health of the embryo and/or fetus in said subject comprises promoting limb and nervous system development. 
     
     
         14 . The method of  claim 13 , wherein promoting the health of the embryo and/or fetus in said subject comprises promoting muscle growth and differentiation. 
     
     
         15 . The method of  claim 13 , wherein promoting the health of the embryo and/or fetus in said subject comprises promoting neural tube development. 
     
     
         16 . The method of  claim 13 , wherein enhancing expression of one or more genes associated with establishment of and/or maintenance of pregnancy reduces the risk of and/or incidence of an event selected from the group consisting of spontaneous abortion, miscarriage, and birthing complications. 
     
     
         17 . The method of  claim 1 , wherein the subject is a human. 
     
     
         18 . The method of  claim 1 , wherein the subject is a non-human mammal. 
     
     
         19 . The method of  claim 1 , wherein the subject is selected from the group consisting of a subject from an avian species and a subject from an aquatic species. 
     
     
         20 . The method of  claim 1 , wherein said expression is enhanced two fold or greater in said subject compared to the control subject. 
     
     
         21 . The method of  claim 1 , wherein said composition comprising selenium is administered in such a way so as to provide between 100 and 400 μg of selenium to said subject each day. 
     
     
         22 . The method of  claim 1 , wherein said subject is administered said composition for a period of no less than 6 months prior to establishing and/or attempting to establishing a pregnancy. 
     
     
         23 . The method of  claim 1 , wherein said subject is administered said composition during pregnancy. 
     
     
         24 . The method of  claim 1 , wherein said one or more genes associated with establishment of and/or maintenance of pregnancy in a subject are selected from the group consisting fibroblast growth factor 2 (FGF2), SNF1-like kinase, platelet-derived growth factor alpha (PDFGA), cyclin D1 (CCND1), activin A receptor type 1 (ACVR1), Sp3 transcription factor (SP3), homeobox A7, homeobox D12, retinoic acid receptor beta (RARB), insulin-like growth factor binding protein 7, and Protein Kinase A.

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