# US 7,408,046 B2 · Treatment of bone-associated cancers

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- Number: US 7,408,046 B2
- Document ID: US7408046B2
- Status: Granted
- Kind: B2
- Application number: 10/882,054
- Filed: 2004-06-30
- Published: 2005-10-27
- Granted: 2008-08-05
- Earliest claimed: 1999-06-11
- Assignees: Poniard Pharmaceuticals, Inc.
- Inventors: Alan R. Fritzberg; Paul G. Abrams; Lauren Marie Tatalick; Kent R. Thoelke; James Kyle Bryan; Mark D. Hylarides; Elizabeth K. John
- Web page: https://patentgrep.com/patent/US7408046B2

## CPC

- A61K 51/0482: {chelates from cyclic ligands, e.g. DOTA}
- A61K 51/0478: {complexes from non-cyclic ligands, e.g. EDTA, MAG3}
- A61K 51/0489: {Phosphates or phosphonates, e.g. bone-seeking phosphonates; (phospholipids: A61K51/0408; nucleotides or nucleic acids: A61K51/0491)}
- A61P 5/28: Antiandrogens
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 19/00: Drugs for skeletal disorders
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/06: for tuberculosis
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 35/04: specific for metastasis
- A61P 39/06: Free radical scavengers or antioxidants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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 present invention relates to a method of suppressing bone marrow (BM) and treating conditions that arise in or near bone such as cancer, myeloproliferative diseases, autoimmune diseases, infectious diseases, metabolic diseases or genetic diseases, with compositions having as their active ingredient a radionuclide complexed with a chelating agent such as macrocyclic aminophosphonic acid.

## Claims

### Claim 1

A therapeutic method for treating a bone-associated cancer comprising:
(a) parenterally administering a dose of 153Sm-EDTMP to said patient in an aqueous vehicle comprising an effective antiradiolytic amount of a pharmaceutically acceptable radioprotectant; and
(c) administering to said patient an effective amount of chemotherapeutic agent in conjunction with 153Sm-EDTMP wherein the patient is not subjected to total body irradiation or stem cell transplantation in conjunction with the therapeutic method.

### Claim 2 (depends on 1)

The method of claim 1 wherein the cancer is multiple myeloma.

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

The method of claims 1 or 2 wherein the patient is treated with chemotherapy prior to step (a).

### Claim 4 (depends on 1, 2)

The method of claims 1 or 2 wherein the patient is treated with chemotherapy after step (c).

### Claim 5 (depends on 1)

The method of claim 1 wherein the radioprotectant is ascorbic acid or gentistic acid.

### Claim 6 (depends on 5)

The method of claim 5 wherein the concentration of ascorbic acid is about 35-75 mg/ml.

### Claim 7 (depends on 1)

The method of claim 1 wherein the vehicle is buffered to about pH 7-8.

### Claim 8 (depends on 1)

The method of claim 1 where the cancer is metastatic breast or prostate cancer.

### Claim 9 (depends on 1)

The method of claim 1 wherein the dose is subablative.

### Claim 10 (depends on 8, 9)

The method of claim 8 or 9 wherein the chemotherapeutic agent is a bisphosphonate.

### Claim 11 (depends on 3)

The method of claim 3 wherein the chemotherapeutic agent is a bisphosphonate.

### Claim 12 (depends on 4)

The method of claim 4 wherein the chemotherapeutic agent is a bisphosphonate.

### Claim 13

A therapeutic method for treating a bone-associated cancer comprising:
(a) parenterally administering a dose of 153Sm-EDTMP to said patient in an aqueous vehicle; and
(c) administering to said patient an effective amount of a bisphosphonate in conjunction with said 153Sm-EDTMP wherein the patient is not subjected to total body irradiation or stem cell transplantation in conjunction with the therapeutic method.

### Claim 14 (depends on 13)

The method of claim 13 wherein the cancer is metastatic prostate cancer or metastatic breast cancer.

### Claim 15 (depends on 13, 14)

The method of claims 13 or 14 wherein the patient is treated with the bisphosphonate prior to step (a).

### Claim 16 (depends on 13, 14)

The method of claims 13 or 14 wherein the patient is treated with the bisphosphonate after step (a).

### Claim 17 (depends on 13, 14)

The method of claims 13 or 14 wherein the bisphosphonate is pamidronate, clodronate, zoledronate, etidronate, tiludronate or alerdronate.

### Claim 18 (depends on 13, 14)

The method of claims 13 or 14 wherein the aqueous vehicle further comprises an effective antiradiolytic amount of a pharmaceutically acceptable radioprotectant.

### Claim 19 (depends on 13)

The method of claim 13 wherein the vehicle is buffered to about pH 7-8.

### Claim 20 (depends on 13, 14)

The method of claim 13 or 14 wherein the dose is subablative.