# US 2014/0155344 A1 · Combination therapy methods for treating proliferative diseases

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- Number: US 2014/0155344 A1
- Document ID: US20140155344A1
- Status: Published application
- Kind: A1
- Application number: 13/701,001
- Filed: 2011-05-20
- Published: 2014-06-05
- Earliest claimed: 2010-06-07
- Inventors: Neil P. Desai; Patrick Soon-Shiong
- Web page: https://patentgrep.com/patent/US20140155344A1

## CPC

- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/146: {with organic macromolecular compounds}
- A61K 9/5169: {Proteins, e.g. albumin, gelatin}
- A61K 31/16: Amides, e.g. hydroxamic acids
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 31/282: Platinum compounds
- A61K 31/706: containing six-membered rings with nitrogen as a ring hetero atom
- A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/10: of the bladder
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/00: Drugs for dermatological disorders
- A61P 35/00: Antineoplastic agents
- 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 provides combination therapy methods of treating a proliferative disease (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include the administration of an effective amount of at least one other agent that modifies the epigenetics in a cell.

## Claims

### Claim 1

A method of treating a proliferative disease in an individual comprising administering to the individual:
a) an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, and
b) an effective amount of at least one other agent that modifies the epigenetics in a cell.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said other agent is an inhibitor of histone deacetylase.

### Claim 3 (depends on 2)

The method according to claim 2, wherein said other agent is vorinostat.

### Claim 4 (depends on 3)

The method according to claim 3, further comprising administering to said individual a platinum-based agent.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said other agent is an inhibitor of DNA methylransferase.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the other agent is azacitidine.

### Claim 7 (depends on 5)

The method according to claim 5, wherein the other agent is decitabine.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the proliferative disease is cancer.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the cancer is breast cancer.

### Claim 10 (depends on 9)

The method according to claim 9, wherein the individual is negative for ER, PR, or HER2.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the individual is negative for ER, PR, and HER2.

### Claim 12 (depends on 8)

The method according to claim 8, wherein the cancer is ovarian cancer.

### Claim 13 (depends on 8)

The method according to claim 8, wherein the cancer is non-small lung cancer.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the composition comprising nanoparticles comprising taxane and albumin and the other agent are administered simultaneously.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the composition comprising nanoparticles of taxane and albumin and the other agent are administered sequentially.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the composition comprising nanoparticles of taxane and albumin and the other agent are administered concurrently.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the taxane is paclitaxel.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the carrier protein is albumin.

### Claim 20 (depends on 19)

The method according to claim 19, wherein the weight ratio of the albumin and the taxane in the nanoparticle composition is less than about 1:1 to about 18:1.

### Claim 21 (depends on 20)

The method according to claim 20, wherein the weight ratio of the albumin and the taxane in the nanoparticle composition is less than about 1:1 to about 9:1.

### Claim 22 (depends on 1)

The method according to claim 1, wherein the individual is a human.

### Claim 23

A kit comprising: a) a composition comprising nanoparticles comprising a taxane and a carrier protein, and b) an effective amount of at least one other agent that modifies the epigenetics in a cell.

### Claim 24

(canceled)
