Alpha Thymosin Peptides as Cancer Vaccine Adjuvants

• US 20100092499A1
• Filed: 12/06/2005
• Published: 04/15/2010
• Est. Priority Date: 12/06/2004
• Status: Abandoned Application

• Current Assignee: SciClone Pharmaceuticals, Inc.
• Original Assignee: SciClone Pharmaceuticals, Inc.
• Inventors: Moviglia, Gustavo Antonio, Rudolph, Alfred R.
• Application Number:
  US11/720,909
• Publication Number:
  US 20100092499A1
• Time in Patent Office: Days
• US Class Current: 424/185.1
• CPC Class Codes: A61K 2039/5154 Antigen presenting cells [APCs], e.g. dendritic cells or macrophages
• CPC Class Codes: A61K 2039/80 Vaccine for a specifically defined cancer
• CPC Class Codes: A61K 2239/49 Breast
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 39/0011 Cancer antigens
• CPC Class Codes: A61K 39/4615 Dendritic cells
• CPC Class Codes: A61K 39/4622 Antigen presenting cells
• CPC Class Codes: A61K 39/4644 Cancer antigens
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/02 Immunomodulators

Abstract

A pharmaceutical combination and method for enhancing cancer vaccine effectiveness in a subject, utilize an immune response-triggering cancer vaccine capable of eliciting an immune system response in a subject; and a vaccine effectiveness-enhancing amount of an alpha thymosin peptide, which enhances the immune system response in the subject, wherein the cancer vaccine and the alpha thymosin peptide can be administered separately or together.

Claims

1. A pharmaceutical combination for treatment of cancer in a subject and for enhancing cancer vaccine effectiveness in the subject, comprising:

a) an immune response-triggering cancer vaccine capable of eliciting an immune system response in said subject; and

b) a vaccine effectiveness-enhancing amount of an alpha thymosin peptide, which enhances said immune system response in said subject;

c) wherein said cancer vaccine and said alpha thymosin peptide can be administered separately or together.

2. A pharmaceutical combination of claim 1, wherein said subject is human, and said vaccine is a dendritic cell vaccine.

3. The pharmaceutical combination of claim 1, wherein said vaccine is in an amount of from about 1×

10<sup>−

9</sup> g to about 1×

10<sup>−

3</sup> g, and said alpha thymosin peptide is in an amount of about 0.1-20 mg.

4. The pharmaceutical combination of claim 1, wherein said vaccine is in an amount of from about 1×

10<sup>−

8</sup> g to about 1×

10<sup>−

4</sup> g, and said alpha thymosin peptide is in an amount of about 0.5-10 mg.

5. The pharmaceutical combination of claim 4 wherein said alpha thymosin peptide is TA1, and the amount of said TA1 is about 1.6-3.2 mg.

6. The pharmaceutical combination of claim 1 wherein said cancer is breast cancer.

7. The pharmaceutical combination of claim 1 wherein said cancer is selected from the group consisting of primary melanoma, metastatic melanoma, adenocarcinoma, squamous cell carcinoma, adenosquamous cell carcinoma, thymoma, lymphoma, sarcoma, lung cancer, liver cancer, non-Hodgkins lymphoma, Hodgkins lymphoma, leukemias, uterine cancer, prostate cancer, ovarian cancer, pancreatic cancer, colon cancer, multiple myeloma, neuroblastoma, NPC, bladder cancer, cervical cancer, kidney cancer, brain cancer, bone cancer, uterine cancer, stomach cancer and rectal cancer.

8. A method of treating cancer in a subject comprising administering to the subject a pharmaceutical combination according to claim 1 for enhancing cancer vaccine effectiveness in said subject, said pharmaceutical combination comprising:

a) an immune response-triggering cancer vaccine capable of eliciting an immune system response in said subject; and

b) a vaccine effectiveness-enhancing amount of an alpha thymosin peptide, which enhances said immune system response in said subject;

c) wherein said cancer vaccine and said alpha thymosin peptide can be administered separately or together;

said method comprising administering said immune response-trigging cancer vaccine to said subject in conjunction with administering said alpha thymosin peptide to said subject, wherein said vaccine and said alpha thymosin peptide are administered to said subject separately or together.

9. The method of claim 8, wherein said subject is human, and said vaccine is a dendritic cell vaccine.

10. The method of claim 8, wherein said vaccine is in an amount of from about 1×

10<sup>−

9</sup> g to about 1×

10<sup>−

3</sup> g, and said alpha thymosin peptide is administered in an amount of about 0.1-20 mg.

11. The method of claim 8, wherein said vaccine is administered in an amount of from about 1×

10<sup>−

8</sup> g to about 1×

10<sup>−

4</sup> g, and said alpha thymosin peptide is in an amount of from about 0.5-10 mg.

12. The method of claim 11 wherein said alpha thymosin peptide is TA1, and said TA1 is administered in an amount of about 1.6-3.2 mg.

13. The method of claim 12, wherein said TA1 is administered substantially concurrently with administration of said vaccine.

14. The method of claim 12, wherein said vaccine and said TA1 are administered by injection.

15. The method of claim 8 wherein said combination is administered to said subject a plurality of times.

16. The method of claim 15 wherein said vaccine is administered to said subject 4-10 times during a course of administration.

17. The method of claim 16 wherein said vaccine is administered to said subject every third week during said course of administration.

18. The method of claim 17 wherein said alpha thymosin peptide is TA1, and wherein said TA1 is administered twice weekly during said course of administration.

19. The method of claim 18 wherein said course of administration is about six months.