# US 12,766,120 B2 · Compositions for and methods of precision cancer treatment

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- Number: US 12,766,120 B2
- Document ID: US12766120B2
- Status: Granted
- Kind: B2
- Application number: 18/073,944
- Filed: 2022-12-02
- Published: 2023-06-22
- Granted: 2026-10-20
- Earliest claimed: 2021-11-03
- Applicants: Stanislaw R. Burzynski
- Inventors: Stanislaw R. Burzynski
- Web page: https://patentgrep.com/patent/US12766120B2

## CPC

- A61K 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate
- A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- 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

## Abstract

Disclosed herein are compositions comprising one or more antineoplastons and using those compositions in methods of treating and/or preventing cancer, prolonging the survival of a subject, and preventing and/or decreasing metastasis of cancer.

## Claims

### Claim 1

A method for treating cancer, the method comprising:
sequencing a biological sample obtained from a subject having metastatic and/or terminal pancreatic cancer; and
if one or more genomic aberrations in a combination of cancer related genes in the biological sample are identified, then administering to the subject a therapeutically effective amount of A10 and AS2-1,
wherein A10 comprises phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG) in a 4:1 ratio;
wherein AS2-1 comprises phenylacetate (PN) and PG in a 4:1 ratio;
wherein the combination of cancer related genes comprises ARID1A, KIT, KRAS, NF1, SMAD4, and TP53; and
measuring the subject's tumor response and/or molecular response to the A10 and AS2-1,
wherein treating the cancer comprises increasing the subject's survivability, increasing the length of time before metastasis, reducing the likelihood of surgical intervention, reducing the need for administration of one or more additional therapeutic agents or regiments, reducing the size of one or more tumors in the subject, eliminating one or more tumors in the subject, reducing or eliminating the prevalence of one or more genomic aberrations, restoring the normal metabolism of one or more organ systems in the subject, restoring one or more aspect of cellular homeostasis and/or cellular functionality and/or metabolic dysregulation, or any combination thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the dose of A10 comprises about 0.4 g/kg/day to about 16 g/kg/day PG and about 0.1 g/kg/day to about 4 g/kg/day iso-PG.

### Claim 3 (depends on 1)

The method of claim 1, wherein the dose of AS2-1 comprises about 0.064 g/kg/day to about 0.48 g/kg/day PN and about 0.016 g/kg/day to about 0.12 g/kg/day PG.

### Claim 4 (depends on 1)

The method of claim 1, further comprising administering to the subject one or more additional therapeutic agents.

### Claim 5 (depends on 4)

The method of claim 4, wherein the one or more additional therapeutic agents comprise bevacizumab, pazopanib, sorafenib, dasatinib, everolimus, or any combination thereof.

### Claim 6 (depends on 1)

The method of claim 1, further comprising repeating the administering to the subject of the A10 and AS2-1.

### Claim 7 (depends on 1)

The method of claim 1, wherein the one or more genomic aberrations comprise mutations, insertions, deletions, chromosomal rearrangements, copy number aberrations, or any combination thereof.

### Claim 8 (depends on 1)

The method of claim 1, wherein the presence of the one or more genomic aberrations in the combination of cancer related genes in the biological sample obtained from the subject indicates that the administration of A10 and AS2-1 is likely to achieve a tumor response and/or a molecular response.

### Claim 9 (depends on 1)

The method of claim 1, further comprising obtaining one or more biological samples from the subject.

### Claim 10 (depends on 1)

The method of claim 1, wherein
(i) if the expression and/or amount of the one or more genomic aberrations in the biological sample obtained after administering the A10 and AS2-1 is lower than the expression and/or amount of the same one or more genomic aberrations in a pre-administration biological sample, then continuing to administer to the subject the A10 and AS2-1, or
(ii) if the expression and/or amount of the one or more genomic aberrations in the biological sample obtained after administering the A10 and AS2-1 is lower than the expression and/or amount of the same one or more genomic aberrations in a prior sample obtained after administering the A10 and AS2-1, then continuing to administer to the subject the A10 and AS2-1.

### Claim 11 (depends on 4)

The method of claim 4, wherein the one or more additional therapeutic agents comprise chemotherapeutic agents, monoclonal antibodies, small molecules, or any combination thereof.

### Claim 12 (depends on 11)

The method of claim 11, wherein monoclonal antibodies comprise adotrastuzumab, alemtuzumab, atezolizumab, avelumab, bevacizumab, blinatumomab, brentuximab, cemiplimab, cetuximab, daratumumab, denosumab, dinutuximab, durvalumab, elotuzumab, gemtuzumab, ibritumomab, inotuzumab, ipilimumab, necitumumab, nivolumab, obinutuzumab, ofatumumab, olaratumab, panitumumab, pembrolizumab, pertuzumab, ramucirumab, rituximab, tositumomab, trastuzumab, or any combination.

### Claim 13 (depends on 11)

The method of claim 11, wherein small molecules comprise abemaciclib, afatinib, alectinib, alpelisib, axitinib, binimetinib, bosutinib, brigatinib, cabozantinib, carfilzomib, ceritinib, cgilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, dasatinib, duvelisib, encorafenib, entrectinib, erdafitinib, erlotinib, gefitinib, ibrutinib, imatinib, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, marizomib, neratinib, nilotinib, niraparib, olaparib, osimertinib, palbociclib, pazopanib, ponatinib, regorafenib, ribociclib, rucaparib, sorafenib, sunitinib, talazoparib, trametinib, vandetanib, vemurafenib, or any combination thereof.

### Claim 14 (depends on 1)

The method of claim 1, wherein
(i) the subject has not received treatment prior to the administering of the A10 and AS2-1, or
(ii) wherein the subject has received treatment prior to the administering of the A10 and AS2-1, and
wherein the treatment comprises surgical treatment, antibody treatment, chemotherapy treatment, radiation treatment, immunotherapy treatment, or any combination thereof.
