Formulations of histone deacetylase inhibitor in combination with bendamustine and uses thereof

Patent metadata

Field	Value
Publication number	US-9492423-B2
Application number	US-201114344314-A
Country	US
Kind code	B2
Filing date	Sep 13, 2011
Priority date	Sep 13, 2011
Publication date	Nov 15, 2016
Grant date	Nov 15, 2016

Abstract

Dosing regimens, methods of treatment, controlled release formulations, and combination therapies that include bendamustine, or a pharmaceutically acceptable salt thereof and an HDAC inhibitor, or a pharmaceutically acceptable salt thereof, are described.

First claim

What is claimed is:

1. A pharmaceutical composition, comprising:
(a) Compound 1:

or a pharmaceutically acceptable salt thereof;
(b) bendamustine or a pharmaceutically acceptable ester, salt or solvate thereof; and
(c) at least one pharmaceutically acceptable excipient;
wherein (a) and (b) are present in synergistically apoptotic amounts.

2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a solid oral dosage form.

3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a controlled release pharmaceutical composition.

4. The pharmaceutical composition of claim 1 , wherein the pharmaceutically acceptable salt of Compound 1 is an HCl salt.

5. A method of treating a cancer in an individual in need thereof, comprising administering to the individual (a) bendamustine, or a pharmaceutically acceptable ester, salt or solvate thereof; and (b) Compound 1:

or pharmaceutically acceptable salt thereof, wherein (a) and (b) are present in synergistically apoptotic amounts and the cancer is selected from the group consisting of colon cancer, multiple myeloma, and lymphoma.

6. The method of claim 5 , wherein bendamustine and Compound 1, or pharmaceutically acceptable salt of Compound 1, are administered simultaneously.

7. The method of claim 5 , wherein bendamustine and Compound 1, or a pharmaceutically acceptable salt of Compound 1, are administered sequentially.

8. The method of claim 5 , wherein the pharmaceutically acceptable salt of Compound 1 is an HCl salt.

9. The method of claim 5 , further comprising administering to the individual rituximab.

Assignees

• Loury David J
• Buggy Joseph J
• Mody Tarak D
• Verner Erik J
• Purro Norbert
• Balasubramanian Sriram
• Kloos Ioana
• Depil Stephane
• Pharmacyclics Llc

Inventors

• Loury David J
• Buggy Joseph J
• Mody Tarak D
• Verner Erik J
• Purro Norbert
• Balasubramanian Sriram
• Kloos Ioana
• Depil Stephane

Classifications

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title

• A61K9/70

  Web, sheet or filament bases {; Films; Fibres of the matrix type containing drug (hollow drug-filled fibres A61K9/0092)} · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K31/4184

  condensed with carbocyclic rings, e.g. benzimidazoles · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title