# US 10,945,981 B2 · Methods for treating familial adenomatous polyposis

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- Number: US 10,945,981 B2
- Document ID: US10945981B2
- Status: Granted
- Kind: B2
- Application number: 16/875,156
- Filed: 2020-05-15
- Published: 2020-11-19
- Granted: 2021-03-16
- Earliest claimed: 2019-05-17
- Assignees: Cancer Prevention Pharmaceuticals, Inc.
- Applicants: Cancer Prevention Pharmaceuticals, Inc.
- Inventors: Eugene Gerner; Alfred Cohen; Michelle Boytim
- Web page: https://patentgrep.com/patent/US10945981B2

## CPC

- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- 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

Provided are methods for preventing or delaying the need for surgical intervention in a patient having familial adenomatous polyposis (FAP) and an at least partially intact lower gastrointestinal tract. Also provided are methods for preventing or delaying the formation of neoplasia and/or cancer in a patient having FAP. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine and sulindac to a patient having FAP and an intact lower gastrointestinal tract.

## Claims

### Claim 1

A method of treating a patient having familial adenomatous polyposis (FAP), the method comprising administering to the patient a pharmaceutical therapy comprising a combined effective amount of eflornithine and sulindac, wherein the patient has an at least partially intact lower gastrointestinal tract.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method delays or prevents a familial adenomatous polyposis (FAP) event and/or FAP progression in the patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method delays FAP disease progression in the patient.

### Claim 4 (depends on 1)

The method of claim 1, wherein the method delays or prevents the need for excisional intervention.

### Claim 5 (depends on 1)

The method of claim 1, wherein the method delays or prevents the development of adenomas.

### Claim 6 (depends on 5)

The method of claim 5, wherein the adenomas are high risk adenomas.

### Claim 7 (depends on 1)

The method of claim 1, wherein the method delays polyposis progression.

### Claim 8 (depends on 7)

The method of claim 7, wherein the method delays the need for endoscopic excision or surgical resection.

### Claim 9 (depends on 1)

The method of claim 1, wherein the method prevents polyposis progression.

### Claim 10 (depends on 9)

The method of claim 9, wherein the method prevents the need for endoscopic excision or surgical resection.

### Claim 11 (depends on 1)

The method of claim 1, wherein the method delays the formation of colorectal cancer in the patient.

### Claim 12 (depends on 1)

The method of claim 1, wherein the method prevents the formation of colorectal cancer in the patient.

### Claim 13 (depends on 1)

The method of claim 1, wherein the patient has a colorectum, a retained rectum, or an ileal pouch.

### Claim 14 (depends on 1)

The method of claim 1, wherein the combined effective amount of eflornithine and sulindac comprises 750 mg/day eflornithine and 150 mg/day sulindac.

### Claim 15 (depends on 14)

The method of claim 14, wherein the eflornithine and sulindac are administered in a single formulation.

### Claim 16 (depends on 15)

The method of claim 15, wherein the single formulation comprises about 375 mg of eflornithine hydrochloride monohydrate.

### Claim 17 (depends on 15)

The method of claim 15, wherein the single formulation comprises about 288.6 mg of eflornithine in its anhydrous, free base form.

### Claim 18 (depends on 15)

The method of claim 15, wherein the single formulation comprises about 75 mg of sulindac.

### Claim 19 (depends on 15)

The method of claim 15, wherein the single formulation is in the form of a tablet.

### Claim 20 (depends on 15)

The method of claim 15, wherein the patient is administered two units of the single formulation per day.