# US 7,611,846 B2 · Diagnostic methods involving human growth factor huXAG-1

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 7,611,846 B2
- Document ID: US7611846B2
- Status: Granted
- Kind: B2
- Application number: 11/368,664
- Filed: 2006-03-07
- Published: 2006-09-14
- Granted: 2009-11-03
- Earliest claimed: 1996-08-23
- Assignees: Human Genome Sciences, Inc.
- Inventors: Guo-Liang Yu; Patrick J. Dillon; Reinhard Ebner; Gregory A. Endress
- Web page: https://patentgrep.com/patent/US7611846B2

## CPC

- C07K 14/475: Growth factors; Growth regulators
- A61P 35/00: Antineoplastic agents
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

The present invention relates to huXAG-1, huXAG-2 and huXAG-3 proteins which are novel human growth factors. In particular, isolated nucleic acid molecules are provided encoding the huXAG-1, huXAG-2 and huXAG-3 proteins. huXAG-1, huXAG-2 and huXAG-3 polypeptides are also provided as are vectors, host cells and recombinant methods for producing the same. The invention further relates to screening methods for identifying agonists and antagonists of huXAG-1, huXAG-2 or huXAG-3 activity. Also provided are diagnostic and therapeutic uses of huXAG-1, huXAG-2 and huXAG-3.

## Claims

### Claim 1

A diagnostic method comprising:
(a) measuring the protein level of a polypeptide in a sample from an individual, wherein said sample is colon tissue, and wherein said polypeptide has an amino acid sequence at least 95% identical to a sequence selected from the group consisting of:
(i) amino acids from about −20 to about 155 in SEQ ID NO:2;
(ii) amino acids from about −19 to about 155 in SEQ ID NO:2;
(iii) amino acids from about 1 to about 155 in SEQ ID NO:2;
(iv) the amino acid sequence of a full-length polypeptide having the amino acid sequence encoded by the cDNA clone contained in ATCC Deposit No. 97641;
(v) the amino acid sequence of a mature polypeptide having the amino acid sequence encoded by the cDNA clone contained in ATCC Deposit No. 97641; and
(b) comparing said protein level of said individual with a standard huXAG-1 (SEQ ID NO: 2) protein level, whereby an increase or decrease in the protein level over said standard is indicative of the presence or absence of a huXAG-1-related disorder, wherein said protein level of said individual is detected with an antibody.

### Claim 2 (depends on 1)

The diagnostic method of claim 1, wherein said sample is selected from the group consisting of cells, body fluid, and tissue.

### Claim 3 (depends on 1)

The diagnostic method of claim 1, wherein detection with said antibody is an in vitro assay selected from the group consisting of immunohistochemical assay, enzyme linked immunoassay (ELISA), and radioimmunoassay (RIA).

### Claim 4 (depends on 1)

The diagnostic method of claim 1, wherein detection with said antibody is an in vivo imaging assay selected from the group consisting of X-radiography, nuclear magnetic resonance (NMR), and electron spin resonance (ESR).

### Claim 5 (depends on 1)

The diagnostic method of claim 1, wherein the antibody is a polyclonal antibody.

### Claim 6 (depends on 1)

The diagnostic method of claim 1, wherein the antibody is a monoclonal antibody.

### Claim 7 (depends on 3)

The diagnostic method of claim 3, comprising contacting huXAG-1 protein in said sample with an immobilized antibody to form a conjugate, and without washing, contacting said conjugate with a labeled antibody specific for huXAG-1.

### Claim 8 (depends on 3)

The diagnostic method of claim 3, comprising contacting huXAG-1 protein in said sample with an immobilized antibody to form a conjugate, washing said immobilized antibody conjugate, and contacting the washed sample with a labeled antibody specific for huXAG-1.

### Claim 9 (depends on 1)

The method of claim 1, wherein the huXAG-1-related disorder is colon cancer.

### Claim 10 (depends on 9)

The method of claim 9, wherein the increase in the protein level over standard is indicative of colon cancer.

### Claim 11 (depends on 2)

The method of claim 2, wherein the body fluid is from an individual suspected of having colon cancer.

### Claim 12 (depends on 9)

The method of claim 9, wherein an equal level or decrease in the protein level over standard is indicative of a lack of colon cancer.

### Claim 13

A method of diagnosing colon cancer in a subject comprising:
a) collecting a biological sample from said subject;
b) measuring huXAG-1 protein level in said biological sample, whereby said protein level is detected with an anti-huXAG-1 antibody, or portion thereof, which binds huXAG-1; and
c) comparing said protein level with a standard from subjects that do not have colon cancer, wherein an enhanced protein level compared to said standard is indicative of the presence of colon cancer in said subject.

### Claim 14 (depends on 13)

The method of claim 13, wherein said biological sample is colon tissue.

### Claim 15 (depends on 13)

The diagnostic method of claim 13, wherein detection with said antibody is an in vitro assay selected from the group consisting of immunohistochemical assay, enzyme linked immunoassay (ELISA), and radioimmunoassay (RIA).

### Claim 16 (depends on 13)

The diagnostic method of claim 13, comprising contacting huXAG-1 protein in said sample with an immobilized antibody to form a conjugate, washing said immobilized antibody conjugate, and contacting the washed sample with a labeled antibody specific for huXAG-1.

### Claim 17

A method of diagnosing the clinical outcome in a colon cancer patient comprising:
a) collecting a biological sample from said colon cancer patient;
b) measuring huXAG-1 protein level in said biological sample, whereby said protein level is detected with an anti-huXAG-1 antibody, or portion thereof, which binds huXAG-1; and
c) comparing said protein level with a standard from subjects that do not have colon cancer, wherein enhanced protein level compared to said standard is indicative of a worse clinical outcome relative to patients expressing the protein at lower levels.

### Claim 18 (depends on 17)

The method of claim 17, wherein said biological sample is colon tissue.

### Claim 19 (depends on 17)

The diagnostic method of claim 17, wherein detection with said antibody is an in vitro assay selected from the group consisting of immunohistochemical assay, enzyme linked immunoassay (ELISA), and radioimmunoassay (RIA).

### Claim 20 (depends on 17)

The diagnostic method of claim 17, comprising contacting huXAG-1 protein in said sample with an immobilized antibody to form a conjugate, washing said immobilized antibody conjugate, and contacting the washed sample with a labeled antibody specific for huXAG-1.