U.S. patent application number 16/803874 was filed with the patent office on 2020-06-25 for composition for use as a support therapy for treatment of tumours, aids and leukaemia.
The applicant listed for this patent is Chiara MOGNA BENASSAI. Invention is credited to Giovanni MOGNA.
Application Number | 20200197453 16/803874 |
Document ID | / |
Family ID | 47720684 |
Filed Date | 2020-06-25 |
United States Patent
Application |
20200197453 |
Kind Code |
A1 |
MOGNA; Giovanni |
June 25, 2020 |
COMPOSITION FOR USE AS A SUPPORT THERAPY FOR TREATMENT OF TUMOURS,
AIDS AND LEUKAEMIA
Abstract
Described in the instant application are methods and
compositions for support therapy in antitumor chemotherapeutic
treatments, in acquired immunodeficiency syndrome treatments and in
leukemia treatments. Said methods and compositions comprise a
bacterial strain belonging to the species Lactobacillus pentosus
and having an antiviral and an antibacterial activity, and a highly
bioavailable zinc internalized in a tyndalized bacterial cell mixed
with at least one rubber, and in particular an alginate and/or a
gel, and in particular a gel.
Inventors: |
MOGNA; Giovanni; (NOVARA,
IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BENASSAI; Chiara
MOGNA; Elena
MOGNA; Vera |
NOVARA
NOVARA
NOVARA |
|
IT
IT
IT |
|
|
Family ID: |
47720684 |
Appl. No.: |
16/803874 |
Filed: |
February 27, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14758211 |
Jun 26, 2015 |
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PCT/IB2013/002890 |
Dec 31, 2013 |
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16803874 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 35/747 20130101;
A61P 31/18 20180101; A61P 35/02 20180101; A61P 35/00 20180101; A61P
37/04 20180101 |
International
Class: |
A61K 35/747 20060101
A61K035/747; A61P 35/02 20060101 A61P035/02; A61P 37/04 20060101
A61P037/04; A61P 35/00 20060101 A61P035/00; A61P 31/18 20060101
A61P031/18 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 31, 2012 |
IT |
MI2012A002270 |
Claims
1. A composition for supporting therapy in antitumor
chemotherapeutic treatments, in acquired immunodeficiency syndrome
treatments and or in leukemia treatments; said composition
comprising bacterial strain Lactobacillus pentosus LPS01 with
number of deposit DSM 21980, deposited on Nov. 14, 2008 by
Probiotical SpA in an effective amount between 1.times.10.sup.8 to
1.times.10.sup.11 CFUs/g; and zinc internalized in a tyndalized
bacterial strain,
2. (canceled)
3. The composition according to claim 1, wherein said tyndalized
bacterial cell is selected from strain Streptococcus thermophilus
ST16 BM DSM 19526 deposited in the DSMZ on Jul. 13, 2007 and strain
Bifidobacterium lactic Bb 1 DSM 17850 deposited in the DSMZ on Dec.
23, 2005.
4. The composition according to claim 1, further comprising at
least one rubber.
5. The composition according to claim 10, wherein said vegetable
rubber is at least one alginate.
6. The composition according to claim 1, further comprising at
least one gel.
7. The composition according to claim 6, wherein said gel is an
Aloe-based gel.
8. The composition according to claim 7, wherein said Aloe-based
gel is a gel based on Aloe arborescens.
9. The composition according to claim 1, wherein said composition
further comprises the bacterial strain Lactobacillus pentosus LPS01
with number of deposit DSM 21980; at least one bacterial strain
internalizing the zinc ion, selected from the group comprising the
strain Streptococcus thermophilus ST16 BM with number of deposit
DSM 19526 and the strain Bifidobacterium lactic Bb 1 with number of
deposit DSM 178505; an alginate, and a product based on Aloe
arborescens.
10. The composition according to claim 4, wherein the at least one
rubber is a vegetable rubber.
11. The composition according to claim 5, wherein the at least one
alginate is sodium alginate.
12. The composition according to claim 7, wherein said aloe-based
gel is based on Aloe arborescens.
13. The composition according to claim 9, wherein said alginate is
sodium alginate.
14. The composition according to claim 9, wherein the product based
on Aloe arborescens is in lyophilized form.
15. The composition according to claim 8, wherein the gel based on
Aloe arborescens is in lyophilized form.
16. The composition according to claim 3, wherein said composition
further comprises the bacterial strain Lactobacillus pentosus LPS01
with number of deposit DSM 21980; at least one bacterial strain
internalizing the zinc ion, selected from the group comprising the
strain Streptococcus thermophilus ST16 BM with number of deposit
DSM 19526 and the strain Bifidobacterium lactic Bb 1 with number of
deposit DSM 178505; an alginate, and a product based on Aloe
arborescens.
17. The composition according to claim 3, wherein said composition
further comprises the bacterial strain Lactobacillus pentosus LPS01
with number of deposit DSM 21980; at least one bacterial strain
internalizing the zinc ion, selected from the group comprising the
strain Streptococcus thermophilus ST16 BM with number of deposit
DSM 19526 and the strain Bifidobacterium lactic Bb 1 with number of
deposit DSM 178505; an alginate, and a product based on Aloe
arborescens.
18. The composition according to claim 17, wherein the product
based on Aloe arborescens is in lyophilized form.
19. The composition according to claim 17, wherein said alginate is
sodium alginate.
20. The composition according to claim 3, further comprising at
least one vegetable rubber.
Description
[0001] The present invention relates to a composition for use as
support therapy in antitumor chemotherapeutic treatments, in
acquired immunodeficiency syndrome treatments and in leukemia
treatments. Said composition comprising a bacterial strain
belonging to the species Lactobacillus pentosus and having an
antiviral and an antibacterial activity and a highly bioavailable
zinc internalized in a tyndalized bacterial cell mixed with at
least one rubber, preferably an alginate and/or a gel, preferably a
gel.
[0002] Chemotherapy is known to result in a reduction of the immune
system activity and a deficit immune system cannot protect the
organism from bacterial and viral infections.
[0003] Moreover, chemotherapy (chemo) is known to have a prevailing
effect on the tumor but, unfortunately, it also has side-effects on
healthy tissues, on all tissues, although mainly on some of them
such as the intestine causing mucositis, nausea, vomiting,
diarrhea, alimentation difficulty and thus malnutrition.
[0004] It would not be possible to administer effective
chemotherapy doses unless a therapy which can contrast--of course
within certain limits--the adverse effects of chemotherapy by means
of a support therapy were implemented.
[0005] Thus, there is still the need to have a support therapy to
chemotherapy, in particular a support therapy for the damages
caused to esophagus, stomach and intestine mucosae, and it is
therefore absolutely necessary to have these mucosae be suitably
protected.
[0006] Moreover, there is still the need to have a support therapy
to chemotherapy, in particular a support therapy to the immune
system since chemotherapy implies a reduction of the effectiveness
of the immune system, which results in a vulnerability of the
organism to bacteria and viruses causing the occurrence of
bacterial and viral infections.
[0007] After a long and deep research activity, the Applicant has
identified and selected a bacterial strain with a strong antiviral
activity. The bacterial strain selected by the Applicant, beyond a
remarkable antiviral activity, has a strong antibacterial activity
since it can produce bacteriocins and/or hydrogen peroxide and/or
metabolites with an antibacterial activity.
[0008] Therefore, the strain selected by the Applicant is unique
since it can exert an antiviral and an antibacterial activity at
the same time.
[0009] The bacterial strain selected by the Applicant shows a
remarkable stimulating activity on the immune system resulting in
the endogenous production of interleukin 17, in particular
interleukin 17A (IL-17A) and gamma-interferon.
[0010] Interleukin IL-17A can exert a vascularizing activity for
vessels in the regions where tumor cells are located. A stronger
blood circulation or vascularization in the vessels allows to
inhibit the production of metastasis since tumor cells are more
localized and coherent. Moreover, the aforesaid proangiogenic
effect allows chemotherapeutic treatments to better penetrate the
tumor mass and allows treatments to be more effective and
localized. Moreover, gamma-interferon has an antiviral
capacity.
[0011] The Applicant has found out that the selected bacterial
strain can activate and stimulate the immune system (IS) so as to
cause a higher endogenous production of interleukin 17, in
particular interleukin 17A (IL-17A) and gamma-interferon.
[0012] An object of the present invention is a bacterial strain
belonging to the species Lactobacillus pentosus having an antiviral
activity (cytokine production) and an antibacterial activity
(bacteriocin production).
[0013] In one embodiment, the bacterial strain belonging to the
species Lactobacillus pentosus and having an antiviral and an
antibacterial activity is the strain Lactobacillus pentosus LPS01
with number of deposit DSM 21980, deposited on Nov. 14, 2008 by
Probiotical SpA in compliance with the Budapest Treaty. Moreover,
the Applicant has found out that IS activation can be carried out
by means of a zinc with a very high bioavailability obtained with a
zinc internalized in a tyndalized bacterial cell, which cell
belongs to a strain belonging to the species B. lactis, preferably
the strain Bifidobacterium lactis Bb 1 DSM 17850 deposited in the
DSMZ on Dec. 23, 2005, which is the object of European Patent
Application no. 08789404 herein incorporated as reference.
[0014] In practice, the Applicant has found out that highly
bioavailable zinc internalized in a tyndalized (inactivated) cell
activates the IS, in particular the thymus which is appointed to
produce T-lymphocytes producing non-toxic endogenous cytokines such
as interleukin IL-17A and gamma-interferon. This mechanism as a
whole is activated thanks to the bacterial strain Lactobacillus
pentosus LPS01 with number of deposit DSM 21980.
[0015] The strain Lactobacillus pentosus LPS01 with number of
deposit DSM 21980 is suitable for the treatment of infections
caused by gram-negative bacteria such as enterococci, coliforms and
E. coli. As a matter of fact, the strain Lactobacillus pentosus
LPS01 DSM 21980 was successfully tested, by producing hydrogen
peroxide, bacteriocins and metabolites, against the following
target pathogens E. coli ATCC 8739, E. coli ATCC 10536, E. coli
ATCC 35218 and E. coli ATCC 25922 with a charge of about
1.times.10.sup.8 CFUs/g.
[0016] The strain Lactobacillus pentosus LPS01 with number of
deposit DSM 21980 was tested in order to evaluate its ability to
modulate in-vitro proliferation and release of cytokines from PBMC
cells from healthy donors. PBMC cells were isolated from human
peripheral blood and co-cultured with the strain Lactobacillus
pentosus LPS01 DSM 21980. The specific stimulation of different
populations of immune cells and the secretion of endogenous
cytokines were monitored by means of FACS and ELISA, respectively.
The results having a statistical value show that the strain
Lactobacillus pentosus LPS01 DSM 21980 induces a remarkable
secretion of endogeous Th1 cytokines with a strong increase for
IL-17A (Table A) and for IFN-.gamma. (Table B).
[0017] The dosage of IL-17A cytokine was made on supernatants from
PBMC cultures stimulated with three single bacterial strains: L.
salivarius DLV1 DSM 25138, L. salivarius LS01 DSM 22775 and L.
pentosus LPS01 DSM 21980, after 5 days of culture. The results
having a statistical value, expressed as IL-17A (pg/ml), are shown
in Table A below.
TABLE-US-00001 TABLE A IL-17A (pg/ml) Basal 13 DLV1 12 LS01 10
LPS01 41
[0018] The three bacterial strains as analyzed showed a different
ability to modulate IL-17A cytokine, in particular there is no
effect for L. salivarius DLV1 DSM 25138 and L. salivarius LS01 DSM
22775, whereas for L. pentosus LPS01 DSM 21980 this has highly
increased the secretion of IL-17A with respect to basal conditions
(Basal).
[0019] The dosage of gamma-interferon was made on PBMCs isolated
from human peripheral blood and co-cultured with the strain L.
plantarum LP01 (LMG P-21021) and with the strain L. pentosus LPS01
DSM 21980. The results having a statistical value, expressed as
IFN-gamma (pg/ml), are shown in Table B below.
TABLE-US-00002 TABLE B IFN-gamma (pg/ml) Control 150 LP01 210 LPS01
1550
[0020] The strain L. pentosus LPS01 DSM 21980 shows a 10-time
higher ability to stimulate gamma-interferon than the control.
[0021] Advantageously, the production of endogenous cytokines does
not involve toxicity unlike exogenous cytokines administered by
infusion.
[0022] An object of the present invention is a pharmaceutical
composition or a food composition or a composition including a food
supplement or a composition including a medical device (hereinafter
referred to as the composition according to the present invention),
having the characteristics as claimed in the attached claim.
[0023] Said composition according to the present invention usefully
applies as support therapy in antitumor chemotherapeutic
treatments, in acquired immunodeficiency syndrome treatments and in
leukemia treatments.
[0024] The composition according to the present invention comprises
a rubber, preferably an alginate or a derivative thereof and/or a
gel, preferably an Aloe gel or a derivative thereof.
[0025] The alginate or derivative thereof is preferably a sodium
alginate.
[0026] The Aloe-based product or derivative thereof is preferably
Aloe arborescens; preferably in lyophilized form. Aloe arborescens
is preferably in lyophilized form.
[0027] Both the alginate and the Aloe-based product, once they get
in contact with saliva or with water used for swallowing the tablet
or capsule or for dissolving the granule or powder composition, can
give rise to a gel. The alginate or the Aloe-based product in gel
form can have a mechanical effect or protect mucosae in the
esophagus, stomach and gastro-intestinal tract.
[0028] The alginate, preferably sodium alginate, has a mechanical
anti-regurgitation, anti-esophagitis and anti-gastritis activity
and can make the side-effects of a chemotherapeutic treatment more
tolerable to patients suffering from tumor diseases.
[0029] The Aloe-based product, preferably Aloe arborescens in
lyophilized form, has a mechanical function of physical protection
of esophagus, stomach and intestine mucosae. Moreover, the
Aloe-based product, preferably Aloe arborescens in lyophilized form
and reconstituted in gel form, can reduce the adhesive capacity of
pathogenic strains, in particular of flagellated pathogenic strains
both in the esophagus and in the gastro-intestinal tract. Finally,
the Aloe-based product, preferably Aloe arborescens in lyophilized
form and reconstituted in gel form, can reduce gastric and
intestinal permeability.
[0030] The Aloe-based product, preferably Aloe arborescens in
lyophilized form and reconstituted in gel form, by coating the
esophagus, stomach and intestine mucosae and by reducing the
adhesive capacity of flagellated pathogens, can make the
side-effects (bacterial infections) of a chemotherapeutic treatment
more tolerable to patients suffering from tumor diseases.
[0031] In one embodiment, the composition according to the present
invention comprises sodium alginate and Aloe arborescens in
lyophilized form in a weight ratio of 1:50 (alginate:Aloe) to 50:1,
preferably of 1:30 (alginate:Aloe) to 30:1.
[0032] Said composition according to the present invention further
comprises some bacterial strains in association with alginate,
preferably sodium alginate, and/or the Aloe-based product,
preferably Aloe arborescens in lyophilized form.
[0033] In one embodiment, the composition according to the present
invention comprises in association with alginate, preferably sodium
alginate, and/or the Aloe-based product, preferably Aloe
arborescens in lyophilized form, a bacterial strain belonging to
the species Lactobacillus pentosus having an antiviral and an
antibacterial activity; said strain being the strain Lactobacillus
pentosus LPS01 with number of deposit DSM 21980, deposited on Nov.
14, 2008 by Probiotical SpA.
[0034] In another embodiment, the composition according to the
present invention comprises in association with alginate,
preferably sodium alginate, and/or the Aloe-based product,
preferably Aloe arborescens in lyophilized form, the bacterial
strain Lactobacillus pentosus LPS01 DSM 21980 in association with a
highly bioavailable zinc internalized in a tyndalized bacterial
cell.
[0035] The Applicant has selected some bacterial strains which can
make zinc highly bioavailable (internalized) in the form of a
tyndalized (inactivated) cell. Zinc in this form is highly
bioavailable and as such can be assimilated more easily by the
organism. The zinc ion made bioavailable and easily assimilable by
the organism plays an important role and an action towards the
thymus, which is responsible for the formation/production of
lymphocytes.
[0036] Said bacterial strain internalizing the zinc ion is selected
from the group comprising or, as an alternative, made up of the
strain Streptococcus thermophilus ST16 BM DSM 19526 deposited in
the DSMZ on Jul. 13, 2007 and of the strain Bifidobacterium lactic
Bb 1 DSM 17850 deposited in the DSMZ on Dec. 23, 2005.
[0037] In another embodiment, the composition comprises, in
association with alginate, preferably sodium alginate, and/or the
Aloe-based product, preferably Aloe arborescens in lyophilized
form, the bacterial strain Lactobacillus pentosus LPS01 DSM 21980
in association with a highly bioavailable zinc internalized in a
tyndalized bacterial cell selected from the group comprising or, as
an alternative, made up of the strain Streptococcus thermophilus
ST16 BM DSM 19526 deposited in the DSMZ on Jul. 13, 2007 and of the
strain Bifidobacterium lactic Bb 1 DSM 17850 deposited in the DSMZ
on Dec. 23, 2005.
[0038] An object of the present invention is a composition for use
as support therapy in antitumor chemotherapy treatments, in
acquired immunodeficiency syndrome treatments and in leukemia
treatments; said composition comprising the bacterial strain
Lactobacillus pentosus LPS01 with number of deposit DSM 21980,
deposited on Nov. 14, 2008 by Probiotical SpA. The composition
comprises said strain in an amount of 1.times.10.sup.8 to
1.times.10.sup.11 CFUs/g of composition.
[0039] In one embodiment, said composition further comprises a
highly bioavailable zinc internalized in a tyndalized bacterial
cell. Preferably, said tyndalized bacterial cell is selected from
the group comprising the strain Streptococcus thermophilus ST16 BM
DSM 19526 deposited in the DSMZ on Jul. 13, 2007 and the strain
Bifidobacterium lactic Bb 1 DSM 17850 deposited in the DSMZ on Dec.
23, 2005.
[0040] In another embodiment, said composition further comprises at
least one rubber, preferably a vegetable rubber. Preferably, said
vegetable rubber is at least one alginate, preferably sodium
alginate.
[0041] In another embodiment, said composition further comprises at
least one gel. Preferably, said gel is an Aloe gel, preferably an
Aloe arborescens gel. Still more preferably, said Aloe gel is an
Aloe arborescens gel in lyophilized form.
[0042] In one embodiment, said composition comprises the bacterial
strain Lactobacillus pentosus LPS01 with number of deposit DSM
21980; at least one bacterial strain internalizing the zinc ion,
selected from the group comprising the strain Streptococcus
thermophilus ST16 BM with number of deposit DSM 19526 and the
strain Bifidobacterium lactic Bb 1 with number of deposit DSM
178505; an alginate, preferably a sodium alginate and a product
based on Aloe arborescens, preferably in lyophilized form.
* * * * *