# US 7,608,274 B2 · Therapeutic processes and useful compositions therefor

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- Number: US 7,608,274 B2
- Document ID: US7608274B2
- Status: Granted
- Kind: B2
- Application number: 10/470,611
- Filed: 2003-12-08
- Published: 2005-07-07
- Granted: 2009-10-27
- Earliest claimed: 2000-04-27
- Assignees: Enzo Therapeutics, Inc. c/o Enzo Biochem, Inc.
- Inventors: Yaron Ilan; Elazar Rabbani; Dean L. Engelhardt; Israel Gotsman; James J. Donegan
- Web page: https://patentgrep.com/patent/US7608274B2

## CPC

- A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)}
- A61K 39/001: {Preparations to induce tolerance to non-self, e.g. prior to transplantation}
- A61K 39/12: Viral antigens
- A61K 39/292: {Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen}
- A61K 40/10: characterised by the cell type used
- A61K 40/428: {Undefined tumor antigens, e.g. tumor lysate or antigens targeted by cells isolated from tumor}
- A61K 40/46: Viral antigens
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/12: Antivirals
- A61P 31/18: for HIV
- A61P 31/20: for DNA viruses
- A61P 31/22: for herpes viruses
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 2035/122: {for inducing tolerance or supression of immune responses}
- A61K 2039/5152: {Tumor cells}
- A61K 2039/542: {oral/gastrointestinal}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- C12N 2730/10134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

This invention provides novel processes for therapeutic applications, including the treatment of subjects carrying infectious agents or having impaired autoimmunity or impaired immune condition. The therapeutic applications disclosed herein are also directed at the treatment of cancerous subjects with malignant tumors containing cancerous cells or malignant or cancerous cells. Vaccination processes for preventing infections in subjects are also provided. The novel processes comprise introducing into or administering to a subject one or more antigens, or trained or adopted immune cells. These antigens or immune cells are capable of establishing or increasing at least one first specific immune response and decreasing at least one second specific immune response. Such responses include components, such as cellular immune reaction elements, humoral immune reaction elements and cytokines, the latter also encompassing interferons and lymphokines. Useful compositions are also provided by this invention.

## Claims

### Claim 1

A method for treating chronic or acute HBV infection in a subject, comprising orally administering an effective amount of HBV antigen to said subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the treatment results in a response selected from the group consisting of decreased ALT level, decreased liver pathology, decreased AST level, decreased HB surface antigen, and decreased HB corn antigen.

### Claim 3 (depends on 1)

The method of claim 1, wherein the treatment results in a response selected from the group consisting of decreased viral load, increased T-cell proliferation in response to HBV antigen, increased T-cell secretion of IFN γ in response to HBV antigen, increased CTL against HBV antigen, increased IFN γ and IL-10 gene expression, and increased serum IFN γ.

### Claim 4 (depends on 1)

The method of claim 1, where the HBV antigen is HbsAG preS1+preS2.

### Claim 5 (depends on 1)

The method of claim 1, where said subject is treated to prevent gastric acidity before administering the HBV antigen.

### Claim 6 (depends on 1)

The method of claim 1, where the antigen is administered twice a day.

### Claim 7 (depends on 6)

The method of claim 6, where the antigen is administered for 20 weeks.