# US 8,772,238 B2 · Use of ixolaris, a tissue factor inhibitor, for the treatment of cancer

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- Number: US 8,772,238 B2
- Document ID: US8772238B2
- Status: Granted
- Kind: B2
- Application number: 13/257,455
- Filed: 2010-03-18
- Published: 2012-01-12
- Granted: 2014-07-08
- Earliest claimed: 2009-03-18
- Assignees: The United States of America, as represented by the Secretary, Department of Health and Human Services
- Applicants: Ivo M. B. Francischetti; Robson de Queiroz Monteiro; Jose Marcos C. Ribeiro
- Inventors: Ivo M. B. Francischetti; Robson de Queiroz Monteiro; Jose Marcos C. Ribeiro
- Web page: https://patentgrep.com/patent/US8772238B2

## CPC

- A61K 38/57: from animals; from humans {(A61K38/553, A61K38/556 take precedence)}
- A61K 38/1767: {from invertebrates}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/12: Antihypertensives
- A61P 27/02: Ophthalmic agents
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- 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

The invention provides methods for treatment of tissue factor (TF) mediated or associated diseases or processes, such as cancer, by administering at least an active fragment of an Ixolaris polypeptide to a subject. The invention further includes identification of a subject in need of such treatment, and monitoring a subject for amelioration of at least one sign or symptom of the disease. The invention also features kits.

## Claims

### Claim 1

A method of inhibiting growth of a cell expressing tissue factor (TF), comprising contacting the cell with an effective amount of an Ixolaris polypeptide such that the growth of the cell is inhibited, wherein the amount of Ixolaris polypeptide is 1-250 ug kg−1, wherein the Ixolaris polypeptide is at least 95% identical to SEQ ID NO: 2.

### Claim 2

A method of treating a TF mediated or associated disease or process in a subject, comprising administering to the subject an Ixolaris polypeptide in an amount effective to treat the TF mediated or associated disease or process, wherein the amount of Ixolaris polypeptide is 1-250 ug kg−1, wherein the Ixolaris polypeptide is at least 95% identical to SEQ ID NO: 2.

### Claim 3

A method of treating a tumor in a subject, comprising administering to the subject an Ixolaris polypeptide in an amount effective to treat the tumor, wherein the amount of Ixolaris polypeptide is 1-250 ug kg−1, wherein the Ixolaris polypeptide is at least 95% identical to SEQ ID NO: 2.

### Claim 4 (depends on 1)

The method of claim 1, wherein the cells are selected from the group consisting of: tumor cells, endothelial cells, vascular smooth muscle cells, inflammatory cells, or a combination thereof.

### Claim 5 (depends on 2)

The method of claim 2, wherein the disease is selected from the group consisting of: cancer and a vascular disease.

### Claim 6 (depends on 3)

The method of claim 3, wherein the tumor comprises a solid tumor.

### Claim 7 (depends on 3)

The method of claim 3, wherein the tumor comprises a central nervous system tumor or a squamous cell tumor.

### Claim 8 (depends on 6)

The method of claim 6, wherein the tumor is a glioblastoma.

### Claim 9 (depends on 7)

The method of claim 7, wherein the tumor is a melanoma.

### Claim 10 (depends on 6)

The method of claim 6, wherein the tumor is a metastatic tumor.

### Claim 11 (depends on 3)

The method of claim 3, wherein the method decreases the rate of tumor growth, inhibits tumor growth, shrinks the tumor, or reduces tumor burden.

### Claim 12 (depends on 11)

The method of claim 11, wherein one or more tumor markers are a sign or symptom associated with the presence of a tumor.

### Claim 13

A method of treating cancer in a subject comprising administering to the subject an Ixolaris polypeptide in an amount effective to treat the cancer, wherein the amount of Ixolaris polypeptide is 1-250 ug kg−1, wherein the Ixolaris polypeptide is at least 95% identical to SEQ ID NO: 2.

### Claim 14 (depends on 1)

The method of claim 1, wherein the Ixolaris polypeptide is identical to SEQ ID NO: 2.

### Claim 15 (depends on 1, 2, 3, 13)

The method of and one of claim 1, 2, 3 or 13, wherein the amount of Ixolaris polypeptide is 50 ug kg−1.

### Claim 16 (depends on 1, 2, 3, 13)

The method of and one of claim 1, 2, 3 or 13, wherein the amount of Ixolaris polypeptide is 250 ug kg−1.

### Claim 17 (depends on 1)

The method of claim 1, wherein the amount of Ixolaris polypeptide is 25-250 ug kg−1.

### Claim 18 (depends on 2)

The method of claim 2, wherein the amount of Ixolaris polypeptide is 25-250 ug kg−1.

### Claim 19 (depends on 3)

The method of claim 3, wherein the amount of Ixolaris polypeptide is 25-250 ug kg−1.

### Claim 20 (depends on 13)

The method of claim 13, wherein the amount of Ixolaris polypeptide is 25-250 ug kg−1.

### Claim 21 (depends on 17, 18, 19, 20)

The method of any one of claims 17-20, wherein the amount of Ixolaris polypeptide is 50-250 ug kg−1.