# US 2015/0147294 A1 · Use of il-12 to increase survival

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- Number: US 2015/0147294 A1
- Document ID: US20150147294A1
- Status: Published application
- Kind: A1
- Application number: 14/577,529
- Filed: 2014-12-19
- Published: 2015-05-28
- Earliest claimed: 2008-04-24
- Assignees: Neumedicines, Inc.
- Applicants: Neumedicines, Inc.
- Inventors: Lena A. Basile
- Web page: https://patentgrep.com/patent/US20150147294A1

## CPC

- A61K 38/208: {IL-12}
- A61K 35/14: Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42)
- A61K 38/18: Growth factors; Growth regulators
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 7/06: Antianaemics
- C07K 14/5434: {IL-12}
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- 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
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

The present invention provides methods for increasing survival in a subject, and/or preserving bone marrow function, and/or promoting hematopoietic recovery or restoration. The methods include administering a dose of IL-12 to the subject following an acute exposure to non-therapeutic whole body ionizing radiation. Formulations and kits are also provided.

## Claims

### Claim at position 1

1-27. (canceled)

### Claim 28

A kit for increasing survival in a subject, and/or preserving bone marrow function, and/or promoting hematopoietic recovery or restoration following non-therapeutic acute exposure to whole body ionizing radiation,
the kit comprising one or more formulations of a therapeutically effective dose of Interleukin-12 (IL-12).

### Claim 29 (depends on 28)

The kit of claim 28, wherein the kit is for increasing survival in a human subject, wherein the therapeutically effective dose of IL-12 is between from about 25.66 μg to about 1.71 μg.

### Claim 30 (depends on 28)

The kit of claim 28, wherein the kit is for increasing survival in a human subject, wherein the therapeutically effective dose of IL-12 is less than about 17.11 μg.

### Claim 31 (depends on 28)

The kit of claim 28, wherein the kit is for increasing survival in a human subject, wherein the therapeutically effective dose of IL-12 is less than about 13.68 μg.

### Claim 32 (depends on 28)

The kit of claim 28, wherein the IL-12 is formulated for intravenous, intramuscular, intraperitoneal, intracerebrospinal, subcutaneous, intra-articular, intrasynovial, or intrathecal administration.

### Claim 33 (depends on 28)

The kit of claim 28, wherein the IL-12 is formulated for injection in solution or as a lyophilized powder.

### Claim 34 (depends on 28)

The kit of claim 28, wherein the IL-12 is recombinant IL-12.

### Claim 35 (depends on 34)

The kit of claim 34, wherein the IL-12 is recombinant human IL-12 (rhIL-12).

### Claim 36 (depends on 38)

The kit of claim 38, wherein the rhIL-12 is HemaMax™.

### Claim 37 (depends on 28)

The kit of claim 28, wherein the IL-12 is modified so as to reduce the immunogenicity of the protein.

### Claim 38 (depends on 37)

The kit of claim 37, wherein the IL-12 protein is modified with one or more water-soluble polymers.

### Claim 39 (depends on 28)

The kit of claim 28, wherein the IL-12 is formulated in a tube, vial or syringe.

### Claim 40 (depends on 28)

The kit of claim 28, wherein the IL-12 is administered with a carrier molecule or bulking agent.

### Claim 41 (depends on 40)

The kit of claim 40, wherein the carrier molecule is an albumin.

### Claim 42 (depends on 40)

The kit of claim 40, wherein the carrier molecule is present at a concentration of at least about two times the concentration of IL-12.

### Claim 43 (depends on 28)

The kit of claim 28, comprising multiple unit doses of IL-12.

### Claim 44 (depends on 28)

The kit of claim 28, further comprising a compound useful for supportive care of IL-12 treatment following radiation exposure selected from the group consisting of antibiotics, hematopoietic growth factors, G-CSF, IL-3, erythropoietin, erythropoietin-like molecules, IL-1, IL-4, IL-5, IL-6, IL-7, IL-11, and any combination thereof.

### Claim 45 (depends on 28)

The kit of claim 28, wherein the IL-12 is housed in a radiation proof or radiation resistant container.