# US 11,077,153 B2 · Composition for use in treating or preventing viral or bacterial infections in a subject undergoing anti-tumor chemotherapy, leukemia treatment or aids therapy comprising L. reuteri LER03 and/or L. salivarius LS06

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- Number: US 11,077,153 B2
- Document ID: US11077153B2
- Status: Granted
- Kind: B2
- Application number: 15/307,757
- Filed: 2015-04-30
- Published: 2017-04-27
- Granted: 2021-08-03
- Earliest claimed: 2014-05-05
- Assignees: Chiara Benassai et al.
- Applicants: Chiara Benassai; Elena Mogna; Vera Mogna
- Inventors: Giovanni Mogna
- Web page: https://patentgrep.com/patent/US11077153B2

## CPC

- A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 35/745: Bifidobacteria
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 31/18: for HIV
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A composition for use as adjunctive therapy to antitumor chemotherapeutic treatments, acquired immunodeficiency syndrome treatments and leukemia treatments is described. The composition includes a strain of bacteria Lactobacillus reuteri LRE 03 DSM 23879 which is able to strongly stimulate the production of pro-inflammatory cytokines (Th1) interferon INF-gamma, the cytokines exhibiting a marked antiviral and/or antibacterial activity, and/or a bacterial strain Lactobacillus salivarius LS06 DSM 26037 which is able to strongly stimulate dendritic cell production, the dendritic cells exhibiting a marked antiviral and/or antibacterial activity. The composition can include one or more of: a bacterial strain able to produce, when ingested, bacterial exopolysaccharides EPS; and/or a plant polysaccharide such as tara gum; and/or an Aloe arborescens gel; and/or a gelling agent such as sodium alginate and/or a highly bioavailable zinc internalized into a tyndallized bacterial cell.

## Claims

### Claim 1

A method to provide an adjunctive therapy to an individual undergoing antitumor chemotherapeutic treatment, acquired immunodeficiency syndrome treatment or leukemia treatment, the method comprising
administering to the individual an antiviral and/or antibacterial composition comprising:
a strain of bacteria belonging to the species Lactobacillus reuteri identified as Lactobacillus reuteri LRE03 with deposit number DSM 23879, deposited on 5 Aug. 2010 by Probiotical SpA at DSMZ—Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, and/or
a strain of bacteria belonging to the species Lactobacillus salivarius identified as Lactobacillus salivarius LS06 with deposit number DSM 26037, deposited on 6 Jun. 2012 by Probiotical SpA at DSMZ Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, thereby providing adjunctive therapy to said individual.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said composition further comprises:
a strain of bacteria belonging to the species Lactobacillus fermentum identified as Lactobacillus fermentum LF11 with deposit number DSM 19188, deposited on 20 Mar. 2007 by Anidral S.r.l. Company (now Probiotical S.p.A) at DSMZ Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said composition has a bacterial concentration from 1×108 UFC/g to 1×1012 UFC/g.

### Claim 4 (depends on 2)

The method according to claim 2, wherein said composition comprises:
a strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and a strain of bacteria Lactobacillus salivarius LS06 DSM 26037, in a weight ratio from 1:5 to 5:1,
a strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and a strain of bacteria Lactobacillus fermentum LF11 DSM 19188, in a weight ratio from 1:5 to 5:1, and
a strain of bacteria Lactobacillus salivarius LS06 DSM 26037 and a strain of bacteria Lactobacillus fermentum LF11 DSM 19188, in a weight ratio from 1:5 to 5:1.

### Claim 5 (depends on 3)

The method according to claim 3, wherein said composition comprises:
a strain of bacteria Lactobacillus reuteri LRE03 DSM 23879, a strain of bacteria Lactobacillus salivarius LS06 DSM 26037 and a strain of bacteria Lactobacillus fermentum LF11 DSM 19188 in a weight ratio of 3:2:1, 3:1:1, 2:1:1, 2:2:1, or 1:1:1.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said composition further comprises a strain of bacteria Streptococcus thermophilus ST10 DSM 25246 and a tara gum.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said composition further comprises a gum.

### Claim 8 (depends on 1)

The method according to claim 1, wherein said composition further comprises an Aloe gel, or a derivative thereof.

### Claim 9 (depends on 1)

The method according to claim 1, wherein said composition further comprises Bifidobacterium lactic Bb 1 with deposit number DSM 17850, deposited at DSMZ on 23 Dec. 2005, by BioMan S.r.l. Company.

### Claim 10 (depends on 1)

The method according to claim 1, wherein said composition is administered in an effective amount to protect gastric, esophageal and intestinal mucosae in the individual.

### Claim 11 (depends on 3)

The method according to claim 3, wherein the bacterial concentration is from 1×109 UFC/g to 1×1011 UFC/g.

### Claim 12 (depends on 4)

The method according to claim 4, wherein the strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and the strain of bacteria Lactobacillus salivarius LS06 DSM 26037 are in a weight ratio from 1:3 to 3:1.

### Claim 13 (depends on 4)

The method according to claim 4, wherein the strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and the strain of bacteria Lactobacillus salivarius LS06 DSM 26037 are in a weight ratio from 1:2 to 2:1.

### Claim 14 (depends on 4)

The method according to claim 4, wherein the strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and the strain of bacteria Lactobacillus salivarius LS06 DSM 26037 are in a weight ratio of 1:1.

### Claim 15 (depends on 4)

The method according to claim 4, wherein the strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and a strain of bacteria Lactobacillus fermentum LF11 DSM 19188 are in a weight ratio from 1:3 to 3:1.

### Claim 16 (depends on 4)

The method according to claim 4, wherein the strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and a strain of bacteria Lactobacillus fermentum LF11 DSM 19188 are in a weight ratio from 1:2 to 2:1.

### Claim 17 (depends on 4)

The method according to claim 4, wherein the strain of bacteria Lactobacillus reuteri LRE03 DSM 23879 and a strain of bacteria Lactobacillus fermentum LF11 DSM 19188 are in a weight ratio of 1:1.

### Claim 18 (depends on 7)

The method according to claim 7, wherein said gum is an alginate, an alginate derivative, or a sodium alginate.

### Claim 19 (depends on 8)

The method according to claim 8, wherein the Aloe gel is an Aloe arborescens gel.

### Claim 20 (depends on 19)

The method according to claim 19, wherein the Aloe arborescens gel is freeze-dried.
