IP Library › Granted Patent US 12,622,938
Granted Patent B2
US 12,622,938 · App. 18/326,763 · Granted May 12, 2026

Compositions and methods for modulating inflammatory response

Inventor: Paul E. Stamets (Shelton, WA)
Assignee: TURTLE BEAR HOLDINGS, LLC
A61K36/07A61K9/0053A61K9/48A61K47/10A61K47/26A61P31/14A61K2236/11A61K2236/331
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,622,938
App. No.
18/326,763
Granted
May 12, 2026
Kind
B2
Abstract

Described herein are mushroom compositions and methods for treating, prophylaxis of, or ameliorating symptoms of one or more adverse reactions triggered by an infectious disease or condition that increases an anti-inflammatory response in a subject with such compositions. In one aspect the composition comprises an aqueous or solid fraction of a mycelium, a fermented substrate thereof, or a combination thereof optionally combined with one or more buffering agents, ethanol, and water.

Claims (22)

1 . A method for treating, prophylaxis of, or ameliorating symptoms of an infectious disease in a subject in need thereof comprising:

administering to the subject a therapeutically effective amount of a composition comprising:

580-1,750 mg of an aqueous or solid fraction of Fomitopsis officinalis mycelium, a fermented substrate thereof, or a combination thereof; and

580-1,750 mg of an aqueous or solid fraction of Trametes versicolor mycelium, a fermented substrate thereof, or a combination thereof.

2 . The method of claim 1 , wherein the aqueous or solid fraction comprises beta-glucans.

3 . The method of claim 1 , wherein a dose of the composition is administered to the subject 3 times per day.

4 . The method of claim 1 , wherein the composition is in the form of a capsule.

5 . The method of claim 3 , wherein the dose comprises at least 4 capsules.

6 . The method of claim 1 , wherein the composition is administered to the subject for about 10 to 30 consecutive days.

7 . The method of claim 1 , wherein the composition is administered to the subject for about 14 days.

8 . The method of claim 1 , wherein the subject has COPD, Cardiovascular disease, diabetes mellitus, hypertension, or a combination thereof.

9 . The method of claim 1 , wherein the subject is at least 60 years old.

10 . The method of claim 1 , wherein the composition is administered orally.

11 . The method of claim 1 , wherein the composition further comprises one or more preservatives, flavorings, colorings, stabilizers, emulsifiers, or other pharmaceutically acceptable excipients.

12 . The method of claim 1 , wherein the infectious disease comprises one or more symptoms comprising shortness of breath, wheezing, coughing, yellow mucus, green mucus, blood-tinged mucus, chest pain, breathlessness, rapid breathing, hypoxia, inflammation of the lung tissue, rapid heart rate, or increased blood pressure, or decreased blood pressure.

13 . The method of claim 1 , wherein the infectious disease comprises a bacterial infection.

14 . The method of claim 13 , wherein the bacterial infection comprises one or more of Streptococcus pneumoniae, Mycobacterium tuberculosis, Bordetella pertussis, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Stenotrophomonas maltophila, Staphylococcus aureus, Streptococcus pyogenes, Neisseria meningitidis, Klebsiella pneumoniae , or Non-tuberculosis Mycobacterium.

15 . The method of claim 1 , wherein the infectious disease comprises a viral infection.

16 . The method of claim 15 , wherein the viral infection comprises one or more of Paramyxoviridae (respiratory syncytial virus (RSV), parainfluenza virus (PIV), metapneumovirus (MPV), enteroviruses), Picornaviridae (Rhinovirus, RV), Coronaviridae (CoV), Adenoviridae (Adenovirus), Parvoviridae (HBoV), Orthomyxoviridae (influenza A, B, C, D, Isavirus, Thogotovirus, Quaranjavirus), or Herpesviridae (human herpes viruses, Varicella zoster virus, Epstein-Barr virus, cytomegalovirus).

17 . The method of claim 16 , wherein the CoV comprises one or more of Severe Acute Respiratory Syndrome (SARS-CoV), Middle East Respiratory Syndrome (MERS-CoV), COVID-19 (2019-nCoV, SARS-CoV-2), 229E, NL63, 0043, or HKU1.

18 . The method of claim 1 , wherein the symptoms of an infectious disease comprises an inflammatory response associated with a bacterial or viral infection.

19 . The method of claim 1 , wherein the administration modulates one or more of cytokine storms, neuroinflammation, or blood clotting.

Continuity (4)
Division 17221437 · Apr 2, 2021
Provisional Application 63029830 · May 26, 2020
Provisional Application 63004788 · Apr 3, 2020
Related Publication 20230364168A1 · Nov 16, 2023
References Cited (48)
US 7790175B2 · Eguchi et al. · 2010 [cited by applicant]
US 11730784B2 · Stamets · 2023 [cited by applicant]
US 11779620B2 · Stamets · 2023 [cited by applicant]
US 20090130138A1 · Stamets et al. · 2009 [cited by applicant]
US 20100047269A1 · Eguchi et al. · 2010 [cited by applicant]
US 20110189220A1 · Yang et al. · 2011 [cited by applicant]
US 20120294897A1 · Fiorentino Gomez et al. · 2012 [cited by applicant]
US 20140105928A1 · Stamets et al. · 2014 [cited by applicant]
US 20140364499A1 · Lau et al. · 2014 [cited by applicant]
US 20200023024A1 · Jin · 2020 [cited by applicant]
US 20210308200A1 · Stamets · 2021 [cited by applicant]
US 20210308201A1 · Stamets · 2021 [cited by applicant]
CN 102792851A · 2012 [cited by applicant]
WO 2016161138A1 · 2016 [cited by applicant]
WO 2020014745A1 · 2020 [cited by applicant]
European Search Report for Application No. 21782406.9, dated May 6, 2024 (11 pages). [cited by applicant]
European Search Report for Application No. 21779226.6, dated Mar. 1, 2024 (16 pages). [cited by applicant]
Hsieh, T.-C., et al. “Effects of extracts of Coriolus versicolor (I'm-Yunity™) on cell-cycle progression and expression of interleukins-1β,-6, and-8 in Promyelocytic HL-60 leukemic cells and mitogenically stimulated and… [cited by applicant]
Ho, C. Y., et al. “Differential effect of Coriolus versicolor (Yunzhi) extract on cytokine production by murine lymphocytes in vitro.” International immunopharmacology 4.12 (2004): 1549-1557. [cited by applicant]
Ascherl et al., “Infection With Human Immunodeficiency Virus-1 Increases Expression of Vascular Endothelial Cell Growth Factor in T Cels: Implications for Acquired Immunodeficiency Syndrome-Assicated Vasculopathy”, Bloo… [cited by applicant]
Bachstetter et al., “The p38 MAP Kinase Family as Regulators of Proinflammatory Cytokine Production in Degenerative Diseases of CNS”, Aging and Disease, vol. 1, No. 3, 2010, pp. 199-211. [cited by applicant]
Baig et al., “Evidence of the Covid-19 Virus Targeting the CNS: Tissue Distribution, Host-Virus Interaction, and Proposed Neurotropic Mechanisms”, ACS Chemical Neuroscience, vol. 11, 2020, pp. 995-998. [cited by applicant]
Benson et al., “The mycelium of the [cited by applicant]
Chen et al., “Measuring IL-6 and sIL-6R in serum from patients treated with tocilizumb and/or siltuximab following CAR T cell therapy”, J. Immunol. Meth., vol. 434, 2016, pp. 1-8. [cited by applicant]
Choi et al., “Antithrombotic and Antiplatelet Effects of Cordyceps militaris”, Mycobiology, 2020, 5 pages. [cited by applicant]
Davis et al., “Differential Immune Activating, Anti-Inflammatory, and Regenerative Properties of the Aqueous, Ethanol, and Solid Fractions of a Medicinal Mushroom Blend”, Journal of Inflammation Research, vol. 13, 2020,… [cited by applicant]
De Lemos et al., “Neuroprotective Effects of the Absence of JNK1 or JNK3 Isoforms on Kainic Acid-Induced Temporal Lobe Epilepsy-Like Symptoms”, Molecular Neurobiology, vol. 55, No. 5, 2018, pp. 4437-4452. [cited by applicant]
D'Elia et al., “Targeting the “Cytokine Storm” for Therapeutic Benefit”, Clinical and Vaccine Immunology, vol. 20, No. 3, 2013, pp. 319-327. [cited by applicant]
Diao et al., “Reduction and Functional Exhaustion of T Cells in Patients with Coronavirus Disease”, Frontiers in Immunology, vol. 11, 2020, pp. 1-8. [cited by applicant]
Fabian et al., “A small molecule-kinase interaction map for clinical kinase inhibitors”, Nature Biotechnology, vol. 23, No. 3, 2005, pp. 329-336. [cited by applicant]
Gibbons et al., “Random Regression Models: A Comprehensive Approach to the Analysis of Longitudinal Psychiatric Data”, Psychopharmacology Bulletin, vol. 24, No. 3, 1988, pp. 438-443. [cited by applicant]
Heagerty et al., “Time-Dependent ROC Curves for Censored Survival Data and a Diagnostic Marker”, Biometrics, vol. 56, 2000, pp. 337-344. [cited by applicant]
Hedeker et al., “Random Regression Models for Multicenter Clinical Trials Data”, Psychopharmacology Bulletin, vol. 27, No. 1, 1991, pp. 73-77. [cited by applicant]
International Search Report and Written Opinion for Application No. PCT/US21/25553 dated Aug. 6, 2021 (19 pages). [cited by applicant]
International Search Report and Written Opinion for Application No. PCT/US21/25564 dated Sep. 27, 2021 (18 pages). [cited by applicant]
Laird et al., “Random-Effects Models for Longitudinal Data”, Biometrics, vol. 38, No. 4, 1982, pp. 963-974. [cited by applicant]
Liang et al., “The activation of BDNF reduced inflammation in a spinal cord injury model by TrkB/p38 Mark signaling”, Experimental and Therapeutic Medicine, vol. 17, 2019, pp. 1688-1696. [cited by applicant]
Pleszczynska et al., “Fomitopsis betulina (formerly Piptoporus betulinus): the Iceman's polypore fungus with modern biotechnological potential”, World J Microbiol Biotechnol, vol. 33, No. 83, 2017, 12 pages. [cited by applicant]
Prencipe et al., “Nerve Growth Factor Downregulates Inflammatory Response in Human Monocytes through TrkA”, Journal of Immunology, vol. 192, No. 7, 2014, pp. 3345-3354. [cited by applicant]
Redondo-Castro et al., “Interleukin-1 primes human mesenchymal stem cells towards an anti-inflammatory and pro-trophic phenotype in vitro”, Stem Cell Res. Ther., vol. 8, 2017, pp. 1-11. [cited by applicant]
Savory et al., “Viral Vascular Endothelial Growth Factor Plays a Critical Role in Orf Virus Infections”, Journal of Virology, vol. 74, No. 20, 2000, pp. 10699-10706. [cited by applicant]
Thevarajan et al., “Breadth of concomitant immune responses prior to patient recovery: ac ase report of non-severe Covid-19”, Nature Medicine, vol. 26, 2020, pp. 453-456. [cited by applicant]
Torkelson et al., “Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer”, ISRN Oncology, 2012, pp. 1-7. [cited by applicant]
Velazquez-Salinas et al., “The Role of Interleukin 6 During Viral Infections”, Frontiers in Microbiology, vol. 10, No. 1067, 2019, pp. 1-6. [cited by applicant]
Zheng et al., “Functional exhaustion of antiviral lymphocytes in Covid-19 patients”, Cellular & Molecular Immunology, 2020, 3 pages. [cited by applicant]
Australian Patent Office. Examination Report No. 1 for Application No. 2021246099, dated Feb. 28, 2025 (3 pages). [cited by applicant]
Australian Patent Office. Examination Report No. 1 for Application No. 2021246519, dated Feb. 28, 2025 (3 pages). [cited by applicant]
Canada Patent Office Action for Application No. 3173635 dated Feb. 20, 2026 (8 pages). [cited by applicant]