Method and System for Treating Cancer Cachexia

• US 20160339064A1
• Filed: 08/04/2016
• Published: 11/24/2016
• Est. Priority Date: 02/04/2011
• Status: Active Grant

• Current Assignee: Seed Health, Inc.
• Original Assignee: Joseph E. Kovarik, Katherine Rose Kovarik
• Inventors: Kovarik, Katherine Rose, Kovarik, Joseph E.
• Granted Patent: US 9,585,920 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• 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 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 35/742 Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 38/1758 p53
• CPC Class Codes: A61K 39/35 Allergens
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: C07K 16/00 Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies antibodies with enzymatic activity, e.g. abzymes C12N9/0002

Abstract

Various embodiments of the present invention are directed to the field of Oncology, and in particular, embodiments directed to a method of ameliorating, treating, or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells. In certain embodiments, administration of beneficial bacteria to an individual'"'"'s microbiome that have been modified so as to produce effective amounts of desired compositions, compounds, agents, e.g. tomatidine, p53 protein, etc., is employed to address cancerous conditions. In several embodiments, the administration of such beneficial bacteria and microbes to an individual'"'"'s microbiome invokes either an active (or a passive) immune response to destroy, weaken or render less invasive certain cancerous cells, and preferably maintains muscle tissue to combat cancer cachexia.

Claims

1. A method of treating a cancer using immunotherapy comprising, administering to a microbiome of a subject in need thereof an effective amount of a bacterial composition that expresses p53 protein and tomatidine.

2. The method of claim 1, wherein the cancer is breast cancer, bladder cancer, kidney cancer, or colorectal cancer.

3. The method of claim 1, wherein the cancer is a metastatic cancer.

4. The method of claim 1, wherein the microbiome is the gut microbiome.

5. The method of claim 1, wherein the microbiome is the oral microbiome.

6. The method of claim 1, wherein the microbiome is the skin microbiome.

7. A method of claim 1, wherein the method comprises mucosally administering to the subject an effective amount of the bacterial composition that includes a bacteria that has been modified to express one of tomatidine and p53, said bacteria selected from the group consisting of Streptococcus, Actinomyces, Veillonella, Fusobacterium, Porphromonas, Prevotella, Treponema, Nisseria, Haemophilis, Eubacteria, Lactobacterium, Capnocytophaga, Eikenella, Leptotrichia, Peptostreptococcus, Staphylococcus, and Propionibacterium.

8. The method as set forth in claim 7, further comprising including Streptomyces hygroscopicus in an amount effective to provide rayamycin to the subject.

9. The method of claim 7, wherein the mucosal administration is oral administration.

10. The method of claim 1, wherein said method maintains or increases the muscle mass of an individual suffering from cancer, and wherein the bacterial composition has been modified via a CRISPR-Cas system to express tomatidine.

11. The method of claim 1, wherein the bacterial composition expresses a therapeutically effective amount of tomatidine p53 protein.

12. The method of claim 1, wherein the bacterial composition comprises one of a Chlamydia, Shigella flexneri, Mycoplasma bacteria, and H. pylori.

13. The method of claim 1, wherein the subject is a human female and the bacterial composition comprises Chlamydia.

14. The method of claim 1, wherein the bacterial composition comprises H. pylori bacteria that has been modified using a CRISPR-Cas system to produce tomatidine.

15. A method for treating cancer cachexia in humans comprising administering to the microbiome of an individual a composition comprising a bacteria that has been modified to express a therapeutically effective amount of both tomatidine and p53, said bacteria selected from the group consisting of Streptococcus, Actinomyces, Veillonella, Fusobacterium, Porphromonas, Prevotella, Treponema, Nisseria, Haemophilis, Eubacteria, Lactobacterium, Capnocytophaga, Eikenella, Leptotrichia, Peptostreptococcus, Staphylococcus, Propionibacterium, Chlamydia, Shigella flexneri, Mycoplasma bacteria, H. pylori, and Streptomyces hygroscopicus.

16. A method of treating cancer cachexia in a subject in need of such treatment, said method comprising a step of administering a therapeutically effective amount of a composition comprising bacteria of a species found in the subject'"'"'s gut microbiome, wherein the bacteria has been modified using a CRISPR-Cas system to produce one of tomatidine or p53.

17. The method of claim 16, wherein the bacteria is H. pylori.

18. The method as set forth in claim 16, further comprising administering a therapeutically effective amount of a bacterial composition comprising Streptomyces hygroscopicus in an amount effective to provide rayamycin to the subject.

19. The method of claim 16, wherein the cancer is breast cancer, bladder cancer, kidney cancer, or colorectal cancer.

20. The method of claim 16, wherein the composition comprises bacillus calmette-guerin.