# US 5,102,872 A · Controlled-release formulations of interleukin-2

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- Number: US 5,102,872 A
- Document ID: US5102872A
- Status: Granted
- Kind: A
- Application number: 07/231,757
- Filed: 1988-08-12
- Granted: 1992-04-07
- Earliest claimed: 1985-09-20
- Assignees: Cetus Corporation
- Inventors: Maninder Singh; Jack H. Nunberg; Thomas R. Tice; Michael E. Hudson; Richard M. Gilley; Terrance A. Taforo
- Web page: https://patentgrep.com/patent/US5102872A

## CPC

- A61K 38/27: Growth hormone [GH], i.e. somatotropin
- A61K 38/2013: {IL-2}
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 2039/55533: {IL-2}
- Y10S 930/141: Interleukin
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

Shipping fever, and other stress-related diseases in livestock, are treated by administration of a microencapsulated composition comprising IL-2 conjugated with a polyoxyethylene polymer, and mixed with a release-modulating amount of humen serum albumin. The microcapsules are administered parenterally, and release an effective amount of conjugated IL-2 continuously over a period of 14-30 days. These microcapsules are also effective in the treatment of cancer in mammals.

## Claims

### Claim 1

A composition for continuously delivering a relatively constant, effective amount of PEGyl-IL-2 comprising:
PEGyl-IL-2 with a release-modulating amount of human serum albumin, encapsulated in poly(lactide-co-glycolide) microcapsules.

### Claim 2 (depends on 1)

The composition of claim 1 wherein said PEGyl-IL-2 is present with said HSA in a ratio of about 1:5 to 1:30.

### Claim 3 (depends on 2)

The composition of claim 2 wherein said microcapsules contain 5-20% PEGyl-IL-2+HSA.

### Claim 4

A formulation for administering IL-2 or an IL-2 equivalent continuously over a period of 14-30 days, which formulation comprises:
PEGyl-IL-2 mixed with a release-modulating amount of human serum albumin, encapsulated in poly(lactide-co-glycolide) microcapsules; and
a liquid, pharmaceutically acceptable excipient capable of suspending said microcapsules.

### Claim 5 (depends on 4)

The formulation of claim 4, wherein said formulation comprises only components acceptable for parenteral administration.

### Claim 6 (depends on 1)

The composition of claim 1 wherein said PEGyl-IL-2 is released over 7-30 days.