# US 11,028,446 B2 · Methods for treatment of oncological disorders using an epimetabolic shifter (coenzyme Q10)

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- Number: US 11,028,446 B2
- Document ID: US11028446B2
- Status: Granted
- Kind: B2
- Application number: 16/421,788
- Filed: 2019-05-24
- Published: 2020-05-21
- Granted: 2021-06-08
- Earliest claimed: 2009-05-11
- Assignees: Berg LLC
- Applicants: Berg LLC
- Inventors: Niven Rajin Narain; John Patrick McCook
- Web page: https://patentgrep.com/patent/US11028446B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/06: Antihyperlipidemics
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/04: Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/12: Antihypertensives
- A61P 13/12: of the kidneys
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 35/04: specific for metastasis
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12Q 1/6883: for diseases caused by alterations of genetic material
- G01N 33/5735: {co-enzymes or co-factors, e.g. NAD or ATP}
- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/136: Screening for pharmacological compounds
- C12Q 2600/158: Expression markers
- C12Q 2600/16: Primer sets for multiplex assays
- G01N 2570/00: Omics, e.g. proteomics, glycomics or lipidomics; Methods of analysis focusing on the entire complement of classes of biological molecules or subsets thereof, i.e. focusing on proteomes, glycomes or lipidomes
- G01N 2800/042: Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Methods and formulations for treating oncological disorders in humans using Coenzyme Q10 are described.

## Claims

### Claim 1

A method for treating an oncological disorder in a human, comprising:
administering Coenzyme Q10 (CoQ10) to the human such that treatment occurs, wherein the CoQ10 is in its oxidized form and has a purity between 95% and 100%, and wherein administration of the CoQ10 to the human results in an increase of CoQ10 in the oxidized form in the human, wherein the oncological disorder is selected from the group consisting of pancreatic carcinoma, hepatocellular carcinoma, Ewing's sarcoma, breast cancer, brain cancer, astrocytoma, neuroendocrine cancer, colon cancer, lung cancer, osteosarcoma, prostate cancer, ovarian cancer, Squamous cell Carcinoma, Basal Cell Carcinoma and non-Hodgkin's Lymphoma.

### Claim 2 (depends on 1)

The method of claim 1, wherein the CoQ10 induces apoptosis or cell death mechanism in a cancerous cell of the oncological disorder.

### Claim 3 (depends on 1)

The method of claim 1, wherein the Coenzyme Q10 is administered such that it is maintained in its oxidized form during treatment.

### Claim 4 (depends on 1)

The method of claim 1, further comprising a treatment regimen selected from the group consisting of surgery, radiation, hormone therapy, antibody therapy, therapy with growth factors, cytokines, and chemotherapy.

### Claim 5 (depends on 1)

The method of claim 1, wherein the Coenzyme Q10 is administered by intravenous administration.

### Claim 6 (depends on 1)

The method of claim 1, wherein the Coenzyme Q10 is administered by topical administration.

### Claim 7 (depends on 1)

The method of claim 1, wherein the Coenzyme Q10 is administered with an additional therapeutic agent.

### Claim 8 (depends on 7)

The method of claim 7, wherein the Coenzyme Q10 is administered concurrently with the additional therapeutic agent.

### Claim 9 (depends on 7)

The method of claim 7, wherein the Coenzyme Q10 is administered prior to administration of the additional therapeutic agent.

### Claim 10 (depends on 7)

The method of claim 7, wherein the Coenzyme Q10 is administered subsequent to administration of the additional therapeutic agent.

### Claim 11 (depends on 7)

The method of claim 7, wherein the additional therapeutic agent is a chemotherapeutic agent.

### Claim 12 (depends on 11)

The method of claim 11, wherein the chemotherapeutic agent is selected from the group consisting of amifostine (ethyol), cisplatin, dacarbazine (DTIC), dactinomycin, mechlorethamine (nitrogen mustard), streptozocin, cyclophosphamide, carrnustine (BCNU), lomustine (CCNU), doxorubicin (adriamycin), doxorubicin lipo (doxil), gemcitabine (gemzar), daunorubicin, daunorubicin lipo (daunoxome), procarbazine, mitomycin, cytarabine, etoposide, methotrexate, 5-fluorouracil (5-FU), vinblastine, vincristine, bleomycin, paclitaxel (taxol), docetaxel (taxotere), aldesleukin, asparaginase, busulfan, carboplatin, cladribine, camptothecin, CPT-I1, 10-hydroxy-7-ethyl-camptothecin (SN38), dacarbazine, S-I capecitabine, ftorafur, 5′deoxyflurouridine, UFT, eniluracil, deoxycytidine, 5-azacytosine, 5-azadeoxycytosine, allopurinol, 2-chloro adenosine, trimetrexate, aminopterin, methylene-10-deazaaminopterin (MDAM), oxaplatin, picoplatin, tetraplatin, satraplatin, platinum-DACH, ormaplatin, CI-973, JM-216, and analogs thereof, epirubicin, etoposide phosphate, 9- aminocamptothecin, 10, 11-methylenedioxycamptothecin, karenitecin, 9-nitrocamptothecin, TAS 103, vindesine, L-phenylalanine mustard, ifosphamidemefosphamide, perfosfamide, trophosphamide carmustine, semustine, epothilones A-E, tomudex, 6-mercaptopurine, 6-thioguanine, amsacrine, etoposide phosphate, karenitecin, acyclovir, valacyclovir, ganciclovir, amantadine, rimantadine, lamivudine, zidovudine, bevacizumab, trastuzumab, rituximab, 5-Fluorouracil, Capecitabine, Pentostatin, Trimetrexate, Cladribine, floxuridine, fludarabine, hydroxyurea, ifosfamide, idarubicin, mesna, irinotecan, mitoxantrone, topotecan, leuprolide, megestrol, melphalan, mercaptopurine, plicamycin, mitotane, pegaspargase, pentostatin, pipobroman, plicamycin, streptozocin, tamoxifen, teniposide, testolactone, thioguanine, thiotepa, uracil mustard, vinorelbine, chlorambucil, and combinations thereof.

### Claim 13 (depends on 1)

The method of claim 1, wherein the oncological disorder is pancreatic cancer.

### Claim 14 (depends on 1)

The method of claim 1, wherein the oncological disorder is brain cancer.

### Claim 15 (depends on 1)

The method of claim 1, wherein the CoQ10 is administered at a dose of at least 5 mg/kg.