IP Library Granted Patent US 9,896,731
Granted Patent B2
US 9,896,731 · App. 14/171,419 · Granted Feb 20, 2018

Methods for treatment of oncological disorders using an epimetabolic shifter (coenzyme Q10)

Inventors: Niven Rajin Narain (Cambridge, MA); John Patrick McCook (Frisco, TX)
Assignee: Berg LLC
C12Q1/6886A61K31/00A61K31/122G01N33/57484C12Q2600/106C12Q2600/112C12Q2600/136C12Q2600/158C12Q2600/16G01N2570/00
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Quick Facts
Patent No.
US 9,896,731
App. No.
14/171,419
Granted
Feb 20, 2018
Kind
B2
Abstract

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

Claims (23)

1. A method for treating or preventing a skin oncological disorder in a human, wherein the skin oncological disorder is basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), the method comprising: topically administering a pharmaceutical composition comprising about 3% Coenzyme Q10 (CoQ10) to a target tissue of the human at a dose in the range of 0.1 to 0.5 milligrams of CoQ10 per square centimeter of skin such that treatment or prevention occurs, wherein the CoQ10 is in its oxidized form and has a purity between 95% and 100%, and wherein administration of the composition to the subject results in an increase of CoQ10 in the oxidized form in the subject.

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

3. The method of claim 1 , wherein CoQ10 inhibits angiogenesis in a tumor of the oncological disorder.

4. The method of claim 1 , wherein CoQ10 induces a modulation of immune-related elements within the microenvironment of a cancerous cell of the oncological disorder.

5. The method of claim 1 , wherein CoQ10 induces a change in cell cycle control in a cancerous cell of the oncological disorder.

6. The method of claim 1 , wherein a population of humans are treated and at least 25% of the population experiences a diminishment of symptoms as measured by art-recognized endpoints including tissue pathology, clinical observations, photographic analyses, CT-scan, MRI imaging, blood, serum, or plasma markers of cancer.

7. The method of claim 1 , wherein a population of humans are treated and at least 25% of the population had a systemic Coenzyme Q10 level that was therapeutic for the disorder being treated.

8. The method of claim 1 , wherein the concentration of Coenzyme Q10 in the tissues of the humans being treated is different than that of a control standard of human tissue representative of a healthy or normal state.

9. The method of claim 1 , wherein the treatment occurs via an interaction of Coenzyme Q10 with a protein selected from the group consisting of HNF4-alpha, Bcl-xl, Bcl-xS, BNIP-2, Bcl-2, Birch, Bcl-2-L11 (Bim), XIAP, BRAF, Bax, c-Jun, Bmf, PUMA, cMyc, transaldolase 1, COQ1, COQ3, COQ6, prenyltransferase, 4-hydrobenzoate, neutrophil cytosolic factor 2, nitric oxide synthase 2A, superoxide dismutase 2, VDAC, Bax channel, ANT, Cytochrome c, complex 1, complex II, complex III, complex IV, Foxo 3a, DJ-1, IDH-1, Cpt1C, and Cam Kinase II and any one or more of genes listed in Tables 2-4 & 6-28.

10. The method of claim 1 , wherein Coenzyme Q10 is applied in a topical vehicle to a target tissue at a dose of about 0.12 milligrams of coenzyme Q10 per square centimeter of skin.

11. The method of claim 1 , wherein the oncological disorder is Squamous cell Carcinoma.

12. The method of claim 1 , wherein the oncological disorder is Basal Cell Carcinoma.

13. The method of claim 1 , wherein the oncological disorder is SCC, and wherein the method prevents the pre-cancerous lesion actinic keratosis from progressing into SCC.

14. The method of claim 1 , wherein the composition comprising Coenzyme Q10 is topically applied one or more times per 24 hours for six weeks or more.

15. The method of claim 1 , wherein the composition comprising Coenzyme Q10 is administered in the form of a CoQ10 cream.

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

17. The method of claim 1 , wherein the pharmaceutical composition comprises a CoQ10 cream comprising:

(1) a phase A having Capric/Caprylictriglyceride at 4.00% w/w of the composition, cetyl alcohol at 2.00% w/w of the composition, stearyl alcohol at 1.5% w/w, glyceryl stearate and PEG-100 at 4.5% w/w;

(2) a phase B having glycerin at 2.00% w/w, propylene glycol at 1.5% w/w, ethoxydiglycol at 5.0% w/w, phenoxyethanol at 0.475% w/w, a carbomer dispersion at 40.00% w/w, purified water at 16.725% w/w;

(3) a phase C having triethanolamine at 1.300% w/w, lactic acid at 0.500% w/w, sodium lactate solution at 2.000% w/w, water at 2.5% w/w;

(4) a phase D having titanium dioxide at 1.000% w/w; and

(5) a phase E having CoQ10 21% concentrate at 15.000% w/w.

18. The method of claim 17 , wherein the carbomer dispersion comprises water, phenoxyethanol and propylene glycol.

Assignments (8)
SECURITY INTEREST Recorded Aug 29, 2025
From: BPGBIO INC.
To: BERG SURVIVOR’S TRUST; BERG, KARA ANN; THLIVERIS, ANDREW T.
Reel/Frame 072805/0303 →
CORRECTIVE ASSIGNMENT TO CORRECT THE PATENT NUMBER 8147825 WAS ADDED PREVIOUSLY RECORDED AT REEL: 70903 FRAME: 693. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Apr 30, 2025
From: BPGBIO INC.
To: PHOENIX GENESIS LLC
Reel/Frame 071285/0001 →
SECURITY INTEREST Recorded Apr 21, 2025
From: BPGBIO INC.
To: PHOENIX GENESIS LLC
Reel/Frame 070903/0693 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2023
From: BERG LLC
To: BPGBIO, INC.
Reel/Frame 063842/0405 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2016
From: NARAIN, NIVEN RAJIN; MCCOOK, JOHN PATRICK
To: CYTOTECH LABS, LLC
Reel/Frame 038454/0719 →
CHANGE OF NAME Recorded May 4, 2016
From: BERG PHARMA LLC
To: BERG LLC
Reel/Frame 038605/0066 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2016
From: BERG BIOSYSTEMS, LLC
To: BERG PHARMA LLC
Reel/Frame 038454/0857 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2016
From: CYTOTECH LABS, LLC
To: BERG BIOSYSTEMS, LLC
Reel/Frame 038454/0757 →
Continuity (7)
Continuation 12778094 · May 11, 2010
Provisional Application 61177241 · May 11, 2009
Provisional Application 61177243 · May 11, 2009
Provisional Application 61177244 · May 11, 2009
Provisional Application 61177245 · May 11, 2009
Provisional Application 61177246 · May 11, 2009
Related Publication 20150023940A1 · Jan 22, 2015