Oral therapy of necrotizing enterocolitis

• US 9,562,066 B2
• Filed: 09/25/2013
• Issued: 02/07/2017
• Est. Priority Date: 09/25/2012
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Hackam, David J.
• Primary Examiner(s): Minnifield, Nita M
• Application Number:
  US14/036,960
• Publication Number:
  US 20140086982A1
• Time in Patent Office: 1,231 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A23L 33/17 Amino acids, peptides or proteins
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/711 Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: C07H 21/04 with deoxyribosyl as saccharide radical

Abstract

The present invention relates to methods of treating or reducing the risk of necrotizing enterocolitis (NEC) in an infant comprising orally administering an effective amount of a CpG-ODN. It is based, at least in part, on the results of experiments in which orally administered CpG-ODNs were observed to reduce the histopathology and markers of inflammation in a murine model for NEC. The present invention further provides for oral formulations of CpG-ODN for administration to infants.

Claims

1. An infant nutritional formula comprising a therapeutically effective amount of a CpG-ODN comprising 5′

TCGTCGTTTTGTCGTTCCTGACGTT 3′

(SEQ ID NO;

9), further comprising nutrients selected from the group consisting of proteins, lipids, carbohydrates, electrolytes, and vitamins.

2. The infant nutritional formula of claim 1, where the formula is nutritionally complete.

3. The infant nutritional formula of claim 1, where the concentration of CpG-ODN provides a daily dose of between about 0.1-10 mg/kg.

4. The infant nutritional formula of claim 3 where the daily dose provided is about 1 mg/kg.

5. The infant nutritional formula of claim 1, where the CpG-ODN is comprised in a particle selected from the group consisting of a micelle, liposome, microsphere or nanoparticle.

6. The infant nutritional formula of claim 1, wherein the CpG-ODN comprises one or more phosphorothioate linkage.