# US 8,784,796 B2 · Vaccine immunotherapy for treating hepatocellular cancer in immune suppressed patients

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- Number: US 8,784,796 B2
- Document ID: US8784796B2
- Status: Granted
- Kind: B2
- Application number: 13/940,579
- Filed: 2013-07-12
- Published: 2014-01-09
- Granted: 2014-07-22
- Earliest claimed: 2000-10-27
- Assignees: IRX Therapeutics, Inc.
- Applicants: IRX Therapeutics, Inc.
- Inventors: John W. Hadden
- Web page: https://patentgrep.com/patent/US8784796B2

## CPC

- A61K 39/0011: {Cancer antigens}
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/5383: ortho- or peri-condensed with heterocyclic ring systems
- A61K 31/664: Amides of phosphorus acids
- A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
- A61K 38/191: {Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta}
- A61K 38/193: {Colony stimulating factors [CSF]}
- A61K 38/20: Interleukins [IL]
- A61K 38/2006: {IL-1}
- A61K 38/2013: {IL-2}
- A61K 38/204: {IL-6}
- A61K 38/2053: {IL-8}
- A61K 38/2086: {IL-13 to IL-16}
- A61K 38/21: Interferons {[IFN]}
- A61K 38/217: {IFN-gamma}
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/5154: {Antigen presenting cells [APCs], e.g. dendritic cells or macrophages}
- A61K 2039/5158: {Antigen-pulsed cells, e.g. T-cells}
- A61K 2039/55522: {Cytokines; Lymphokines; Interferons}
- 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

A method for overcoming mild to moderate immune suppression includes the steps of inducing production of naive T-cells and restoring T-cell immunity. A method of vaccine immunotherapy includes the steps of inducing production of naive T-cells and exposing the naive T-cells to endogenous or exogenous antigens at an appropriate site. Additionally, a method for unblocking immunization at a regional lymph node includes the steps of promoting differentiation and maturation of immature dendritic cells at a regional lymph node and allowing presentation of processed peptides by resulting mature dendritic cells, thus, for example, exposing tumor peptides to T-cells to gain immunization of the T-cells. Further, a method of treating cancer and other persistent lesions includes the steps of administering an effective amount of a natural cytokine mixture as an adjuvant to endogenous or exogenous administered antigen to the cancer or other persistent lesions.

## Claims

### Claim 1

A method for treating hepatocellular cancer in a patient, the method comprising: administering to the patient having hepatocellular cancer an effective amount of a natural cytokine mixture comprising the cytokines IL-1beta, IL-2, IL-6, IL-8, IFN-gamma, and TNF-alpha.

### Claim 2 (depends on 1)

The method of claim 1, wherein the natural cytokine mixture is administered to the patient perilymphatically.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method further comprises:
administering to the patient an effective amount of cyclophosphamide.

### Claim 4 (depends on 1)

The method of claim 1, wherein the method further comprises:
administering to the patient an effective amount of cyclophosphamide, and
administering to the patient an effective amount of a nonsteroidal anti-inflammatory drug (NSAID).

### Claim 5 (depends on 1)

The method of claim 1, wherein the method further comprises:
administering to the patient an effective amount of at least one exogenous tumor antigen.

### Claim 6 (depends on 1)

The method of claim 1, wherein the natural cytokine mixture further comprises GM-CSF and G-CSF.