Systemic immune activation method using non CpG nucleic acids

• US 20050181035A1
• Filed: 02/17/2004
• Published: 08/18/2005
• Est. Priority Date: 02/17/2004
• Status: Abandoned Application

• Current Assignee: Colorado State University Research Foundation, Juvaris Biotherapeutics, Inc.
• Original Assignee: Juvaris Biotherapeutics, Inc.
• Inventors: Dow, Steven W., Fairman, Jeffery
• Application Number:
  US10/780,294
• Publication Number:
  US 20050181035A1
• Time in Patent Office: Days
• US Class Current: 424/450
• CPC Class Codes: A61K 9/1272 with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids with cholesterol as the only non-phosphatidyl surfactant A61K9/127; lipids as modifying agent A61K47/543
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

This invention relates to a method for systemic immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from a disease including cancer, a disease associated with allergic inflammation, or an infectious disease. Also disclosed are therapeutic compositions useful in such a method.

Claims

1. A therapeutic composition for the elicitation of a systemic, non-antigen specific immune response in a mammal comprising:

a. a liposome delivery vehicle; and

b. an isolated nucleic acid molecule selected from the group consisting of;

i. an oligonucleotide containing no CpG motifs; and

ii. an isolated nucleic acid vector without a gene insert, or a fragment thereof;

wherein said therapeutic composition elicits a systemic, non-antigen-specific immune response in said mammal.

2. The composition of claim 1, wherein said liposome delivery vehicle comprises lipids selected from the group consisting of multilamellar vesicle lipids and extruded lipids.

3. The composition of claim 1, wherein said liposome delivery vehicle comprises multilamellar vesicle lipids.

4. The composition of claim 1, wherein said liposome delivery vehicle comprises cationic liposomes.

5. The composition of claim 1, wherein said liposome delivery vehicle comprises pairs of lipids selected from the group consisting of DOTMA and cholesterol;

DOTAP and cholesterol;

DOTIM and cholesterol; and

DDAB and cholesterol.

6. The composition of claim 1, wherein said liposome delivery vehicle comprises DOTAP and cholesterol.

7. The composition of claim 1, further comprising a pharmaceutically acceptable excipient.

8. The composition of claim 7, wherein said excipient comprises a non-ionic diluent.

9. The composition of claim 7, wherein said excipient is 5 percent dextrose in water.

10. The composition of claim 1, wherein said composition has a nucleic acid to lipid ratio of from about 1:

1 to about 1;

64.

11. The composition of claim 1, wherein said oligonucleotide is at least 10 base pairs in length.

12. The composition of claim 11, wherein said oligonucleotide is in the range of 10 to 100 base pairs in length.

13. A method for eliciting a systemic, non-antigen specific immune response in a mammal, comprising administering to said mammal an amount of a composition effective to elicit said immune response, wherein said composition comprises:

a. a liposome delivery vehicle; and

b. an isolated nucleic acid molecule selected from the group consisting of;

i. an oligonucleotide containing no CpG motifs; and

ii. an isolated nucleic acid vector without a gene insert or a fragment thereof.

14. The method of claim 13, wherein said liposome delivery vehicle comprises lipids selected from the group consisting of multilamellar vesicle lipids and extruded lipids.

15. The method of claim 13, wherein said liposome delivery vehicle comprises multilamellar vesicle lipids.

16. The method of claim 13, wherein said liposome delivery vehicle comprises cationic liposomes.

17. The method of claim 13, wherein said liposome delivery vehicle comprises pairs of lipids selected from the group consisting of DOTMA and cholesterol;

DOTAP and cholesterol;

DOTIM and cholesterol; and

DDAB and cholesterol.

18. The method of claim 13, wherein said liposome delivery vehicle comprises DOTAP and cholesterol.

19. The method of claim 13, wherein said composition further comprises a pharmaceutically acceptable excipient.

20. The method of claim 19, wherein said excipient comprises a non-ionic diluent.

22. The method of claim 13, wherein said composition has a nucleic acid to lipid ratio of from about 1:

1 to about 1;

64.

21. The method of claim 21, wherein said excipient is 5 percent dextrose in water.