# US 11,994,511 B2 · Biomarkers indicative of prostate cancer and treatment thereof

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- Number: US 11,994,511 B2
- Document ID: US11994511B2
- Status: Granted
- Kind: B2
- Application number: 16/500,722
- Filed: 2018-04-04
- Published: 2023-05-04
- Granted: 2024-05-28
- Earliest claimed: 2017-04-04
- Assignees: University of Miami
- Applicants: University of Miami
- Inventors: Kerry L. Burnstein; Fiorella Magani
- Web page: https://patentgrep.com/patent/US11994511B2

## CPC

- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- G01N 33/5011: {for testing antineoplastic activity}
- A61K 31/52: Purines, e.g. adenine
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- A61P 35/00: Antineoplastic agents
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/5044: {involving specific cell types}
- C12Q 2600/158: Expression markers
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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

## Abstract

Described herein are materials and methods for the treatment of prostate cancer.

## Claims

### Claim 1

A method of decreasing proliferation of prostate cancer cells comprising contacting the cells with doxorubicin (DOX) and N9-isopropylolomoucine (N-9) in an amount effective to decrease proliferation of the cancer cells, wherein the prostate cancer is castrate-resistant prostate cancer (CRPC).

### Claim 2 (depends on 1)

The method of claim 1, wherein the CRPC cells are selected from the group consisting of 22Rv1 cells and C4-2B cells.

### Claim 3 (depends on 1)

The method of claim 1, wherein the amount of DOX in the combination is less than 2 mg/mL.

### Claim 4 (depends on 1)

The method of claim 1, wherein the amount of N-9 in the combination is less than 2 mg/mL.

### Claim 5

A method of treating prostate cancer in a subject in need thereof comprising administering to the subject doxorubicin (DOX) and N9-isopropylolomoucine (N-9) a mitotic cyclin dependent kinase inhibitor in amounts effective to treat prostate cancer in the subject, wherein the prostate cancer is castrate-resistant prostate cancer (CRPC).

### Claim 6 (depends on 5)

The method of claim 5, wherein the subject is resistant to treatment with enzalutamide.

### Claim 7 (depends on 5)

The method of claim 5, wherein the DOX and N-9 are administered to the subject in separate compositions.

### Claim 8 (depends on 5)

The method of claim 5, wherein the DOX and N-9 are administered in the same composition.

### Claim 9 (depends on 7)

The method of claim 7, wherein DOX is administered within 24 hours of N-9.

### Claim 10 (depends on 5)

The method of claim 5, wherein the amount of the DOX in the combination is less than 2 mg/mL.

### Claim 11 (depends on 5)

The method of claim 5, wherein the amount of N-9 in the combination is less than 2 mg/mL.

### Claim 12 (depends on 5)

The method of claim 5, further comprising administering a further therapeutic agent selected from the group consisting of an androgen receptor antagonist, an inhibitor of androgen synthesis, a gonadotropin-releasing hormone (GnRH) agonist and a GnRH antagonist to the subject.

### Claim 13

A method of treating prostate cancer in a subject in need thereof comprising
(a) identifying elevated levels of kinesin family-member 20A (KIF20A), kinesin family-member 23 (KIF23), topoisomerase DNA II alpha (TOP2A), cyclin B1 (CCNB1) cyclin B2 (CCNB2), mitotic checkpoint serine/threonine kinase (BUB1) and mitotic checkpoint serine/threonine kinase B (BUB1b) in a tumor sample from the subject relative to a reference standard; and
(b) administering doxorubicin (DOX) and a mitotic cyclin dependent kinase inhibitor in amounts effective to treat prostate cancer in the subject.

### Claim 14 (depends on 13)

The method of claim 13, wherein the prostate cancer is castrate-resistant prostate cancer (CRPC).