Compositions, devices and methods of use thereof for the treatment of cancers

• US 10,159,714 B2
• Filed: 05/17/2017
• Issued: 12/25/2018
• Est. Priority Date: 02/16/2011
• Status: Active Grant

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: Intarcia Therapeutics, Inc.
• Inventors: Leung, Karling Alice
• Primary Examiner(s): Gudibande, Satyanarayana R
• Application Number:
  US15/597,788
• Publication Number:
  US 20170252409A1
• Time in Patent Office: 587 Days
• Field of Search: None
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: C07K 14/605 Glucagons

Abstract

The use of GLP-1 receptor agonists, such as glucagon-like peptide-1 (GLP-1) or exenatide, for the treatment of cancer is described. The GLP-1 receptor agonists are typically delivered using an implanted osmotic delivery device that provides for continuous delivery of the GLP-1 receptor agonist for at least one month. Additional beneficial agents, such as anticancer agents, can also be administered.

Claims

1. An implantable osmotic delivery device comprising a suspension formulation, the suspension formulation comprising:

(a) a particle formulation comprising semaglutide, sucrose and methionine, the particle formulation having a ratio of semaglutide;

(sucrose+methionine) of from about 2;

1 to about 20;

1, and (b) a non-aqueous vehicle formulation, wherein the particle formulation is dispersed in the non-aqueous vehicle formulation.

2. The implantable osmotic delivery device of claim 1, wherein the particle formulation additionally comprises:

a buffer selected from the group consisting of citrate, histidine, succinate, and mixtures thereof;

the particle formulation is a spray dried preparation of particles, and the suspension formulation has an overall moisture content of less than or equal to about 10 wt %.

3. The implantable osmotic delivery device of claim 1, wherein (a) the particle formulation additionally comprises a buffer and (b) the vehicle formulation is a single-phase suspension vehicle comprising one or more pyrrolidone polymers and one or more solvents selected from the group consisting of lauryl lactate, lauryl alcohol, benzyl benzoate, and mixtures thereof.

4. The implantable osmotic delivery device of claim 3, wherein the buffer is selected from the group consisting of citrate, histidine, succinate, and mixtures thereof.

5. The implantable osmotic delivery device of claim 1, wherein the particle formulation is a spray dried preparation of particles.

6. The implantable osmotic delivery device of claim 1, wherein the vehicle consists essentially of polyvinylpyrrolidone and benzyl benzoate.

7. The implantable osmotic delivery device of claim 1, wherein the vehicle is about 50% solvent and about 50% polymer.

8. The implantable osmotic delivery device of claim 1, wherein the suspension formulation has an overall moisture content of less than or equal to about 10 wt %.