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WO2021152555A1 - Novel immunotherapy for tumours and cancers, and associated inflammation - Google Patents

Novel immunotherapy for tumours and cancers, and associated inflammation Download PDF

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Publication number
WO2021152555A1
WO2021152555A1 PCT/IB2021/050766 IB2021050766W WO2021152555A1 WO 2021152555 A1 WO2021152555 A1 WO 2021152555A1 IB 2021050766 W IB2021050766 W IB 2021050766W WO 2021152555 A1 WO2021152555 A1 WO 2021152555A1
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WIPO (PCT)
Prior art keywords
formulation
tumours
apolar
cancers
picrorhiza
Prior art date
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Ceased
Application number
PCT/IB2021/050766
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French (fr)
Inventor
Munisekhar Medasani
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Individual
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Publication of WO2021152555A1 publication Critical patent/WO2021152555A1/en
Anticipated expiration legal-status Critical
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/68Plantaginaceae (Plantain Family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0031Rectum, anus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms

Definitions

  • Cancers and tumours are increasing year by year with changes in the life style and aging population. USA alone is having about 650,000 cancer related deaths a year.
  • metastatic cancers are with heterogeneity in the cancer cells. Which is making targeted therapies and specific anti-bodies less effective in metastatic cancers.
  • PE is for treatment of cancers and tumours and expected to address: -Heterogeneity in cancers and tumours -inflammation associated with cancers and tumours -safe and having less side-effects
  • PE is a speciality apolar extract from one or more plants materials selected from Picrorhiza kurrooa Royle, Picrorhiza Scrophulariiflora Pennell and Neopicrorhiza scrophulariiflora. Theses 3 plant species are referred as "PK Plants" in this invention. Where in plants materials are mainly of roots and rhizomes of PK Plants.
  • PE is speciality apolar extract which also contains bioactive microRNAs of PK Plants. PE also contains aglycons, steroidal fatty acids and fatty acids of PK Plants.
  • PE proved safe and side effects free, even at higher doses. PE could be used in the form of a vaccine or adjuvant to a vaccine or booster dose to increase or create immunity to the cancers or tumours
  • PE could also be used for treatment of cancers and tumours below detectable limits and micrometastasis in lymph nodes and other organs.
  • PE Since, PE is having potential to modulate immune system, modulate miRNAs, modulate T- Cells, reduce inflammation and has antioxidant effect, PE also can be used for prevention, treatment and management of neurological and neurodegenerative diseases and disorders like Alzheimer's, Parkinson's, Multiple Sclerosis, Amyotrophic Lateral Sclerosis and Autism.
  • PE may be further added or co-administered with Vitamins like A, B, C, D, E, K and Anti-oxidants like Lycopene, Astaxanthin, Glutathione and Enzymes which breaks oxidative stress.
  • this technology may also be used in other medicinal/herbal plants and herbal extractions which are good for treatment of cancers and tumours, like curcumin longa and other

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Dermatology (AREA)
  • Botany (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Mycology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Otolaryngology (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present application relates to an Apolar Picrorhiza Extract (PE) of one or more plants selected from the group consisting of Picrorhiza kurroa, Neopicrorhiza scrophulariiflora, and Picrorhiza scrophulariiflora Pennell for prevention, treatment and management of primary and metastatic cancers and tumours, and associated inflammation. PE is also useful for safe and effective treatment and management for paediatric and geriatric primary and metastatic cancers and tumours.

Description

Novel Immunotherapy for tumours and cancers, and associated inflammation
Description of invention:
Cancers and tumours are increasing year by year with changes in the life style and aging population. USA alone is having about 650,000 cancer related deaths a year.
In spite of research and latest medications like immunothepies and targeted nano therapies, one major issue researchers facing is how to manage the inflammation. Being more than 99% genetically similar to normal cells, Cancer is evading body own defence system and causing inflammation which is making difficult to treat cancers and tumours.
One of the major problem with immunotherapy is , it is targeted to particular type of mechanism in the cancer. But metastatic cancers are with heterogeneity in the cancer cells. Which is making targeted therapies and specific anti-bodies less effective in metastatic cancers.
Present invention, it is PE, is for treatment of cancers and tumours and expected to address: -Heterogeneity in cancers and tumours -inflammation associated with cancers and tumours -safe and having less side-effects
-Effective for even childhood and geriatric cancers and tumours -Effective for inoperable brain tumours and solid tumours
Inventor 's research with PE on in-vitro proved it is able to kill cancer cells, mutated cells , but do not kill healthy and normal cells, whereby it is making best possible immunotherapy for cancers and tumours, mainly for treatment of childhood and geriatric cancers and tumours where their body may not be able to withstand for conventional therapies like radiation and chemotherapy.
PE is a speciality apolar extract from one or more plants materials selected from Picrorhiza kurrooa Royle, Picrorhiza Scrophulariiflora Pennell and Neopicrorhiza scrophulariiflora. Theses 3 plant species are referred as "PK Plants" in this invention. Where in plants materials are mainly of roots and rhizomes of PK Plants.
PE is speciality apolar extract which also contains bioactive microRNAs of PK Plants. PE also contains aglycons, steroidal fatty acids and fatty acids of PK Plants.
PE proved safe and side effects free, even at higher doses. PE could be used in the form of a vaccine or adjuvant to a vaccine or booster dose to increase or create immunity to the cancers or tumours
PE could also be used for treatment of cancers and tumours below detectable limits and micrometastasis in lymph nodes and other organs.
Since, PE is having potential to modulate immune system, modulate miRNAs, modulate T- Cells, reduce inflammation and has antioxidant effect, PE also can be used for prevention, treatment and management of neurological and neurodegenerative diseases and disorders like Alzheimer's, Parkinson's, Multiple Sclerosis, Amyotrophic Lateral Sclerosis and Autism.
For increased efficacy PE may be further added or co-administered with Vitamins like A, B, C, D, E, K and Anti-oxidants like Lycopene, Astaxanthin, Glutathione and Enzymes which breaks oxidative stress.
Since, the process and formulation claimed is able to enhance efficacy, reduce the side- effects and toxicity, reduce the dosage requirement, this technology may also be used in other medicinal/herbal plants and herbal extractions which are good for treatment of cancers and tumours, like curcumin longa and other
Inventor has filed earlier US Patent Appl#20160067292-Bioacive Apolar Extract containing plant genetic material for treatment of mammalian diseases, which is abandoned now.

Claims

Claim:
1. Apolar Picrorhiza Extract (PE) of one or more plants selected from the group consisting of Picrorhiza kurroa, Neopicrorhiza scrophulariiflora, and Picrorhiza scrophulariiflora Pennell for use in subjects as immunotherapy or immune system modulator in the prevention, treatment or management of tumours and cancers, and associated inflammation
2. The PE as claimed in claim 1 comprises, one or more terpenes, and one or more fatty acids, one or more microRNAs wherein the one or more terpenes, one or more fatty acids, one or more microRNAs are collected during apolar extraction
3. The PE as claimed in claim 1 is further comprises NADPH modulators
4. The PE as claimed in claim 1 is further comprises one or more of the other apolar constituents and its degraded constituents of PK Plants.
5. The PE as claimed in claim 1 is substantially free from sugar moieties and polar components.
6. The PE as claimed in claim 1 is extracted using, but not limited to, apolar solvents like n-hexane, super critical carbon dioxide, super critical carbon dioxide and n-hexane
7. The PE as claimed in claim 1 is formulated in the form of a powder, syrup, drink, tablet, caplet, softgel, capsule, nanogel, nano-particles, injections, parenteral, transdermal patches, absorbent gels, nasal sprays, vaginal gel, and adsorbed on an excipient.
8. Formulation as claimed in claim 7 is further added one or more additional components that provide complementary or supplementary therapeutic efficacy and/or are additional factors for nutrition, food, color, taste, texture, odor, flavor, bulk , stability and other characteristics.
9. Formulation as claimed in claim 7 is in a form suitable for administration through oral, intravenous, intramuscular, Intravesical, sub-cutaneous, peritoneal, rectal, nasal, trans-dermal, dermal, sublingual, vaginal or other routes.
10. Formulation as claimed in claim 7 contains PE as an active or key ingredient in the range of lOmg to 500mg per dose
11. Formulation as claimed in claim 7, formulation is in the form of a food/dietary supplement, a medicine, or an alternative medicine with or without added adjuvants.
12. As claimed in claim 1, wherein the subject is an animal
13. As claimed in claim 1, wherein the subject is a human
PCT/IB2021/050766 2020-02-02 2021-02-01 Novel immunotherapy for tumours and cancers, and associated inflammation Ceased WO2021152555A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202016779625A 2020-02-02 2020-02-02
US16/779,625 2020-02-02

Publications (1)

Publication Number Publication Date
WO2021152555A1 true WO2021152555A1 (en) 2021-08-05

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011024196A2 (en) * 2009-08-12 2011-03-03 Munisekhar Medasani Picrorhiza kurroa extract for prevention, elimination and treatment of dna based viruses in humans and in biotech industry

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011024196A2 (en) * 2009-08-12 2011-03-03 Munisekhar Medasani Picrorhiza kurroa extract for prevention, elimination and treatment of dna based viruses in humans and in biotech industry

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE TKDL 2001, "Kukkil Nei-2", XP055846721, Database accession no. GP03/57 *
SONI, DEEPIKA ET AL.: ""Picrosides'' from Picrorhiza kurroa as potential anti-carcinogenic agents", BIOMEDICINE & PHARMACOTHERAPY, vol. 109, 2019, pages 1680 - 1687, XP085552081 *

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