The synergistic composition and methods of treating conditions neoplastic or malignant growth and restore or enhance hematopoiesis

 

The present invention includes receiving a combination of composition, inducing cytotoxic T-lymphocytes, and at least one agent that is able to neutralize or reduce the activity of immunosuppressive factors secreted by the tumor, either individually or in combination, the composition further includes a stabilizing detergent, a micelle-forming agent and a biodegradable and biocompatible oil for manufacture in the form of a stable emulsion of oil in water. Also the claimed methods of treatment of malignant tumors, viral or parasitic diseases with the use of the abovementioned composition. The invention provides a more effective compositions and methods for immunotherapy treatment. 6 C and 31 C.p. f-crystals, 6 ill.

Description text in facsimile form (see graphic part).

Claims

1. Composition comprising (a) a mixture containing tumor, viral, or parasitic antigen expressed by these tumor, infected with a virus or parasite cells, and microfluidizers antigenic composition, and specified antigenic composition comprises (i) stanimaka, moreover, the specified antigenic composition is made in the form of a stable emulsion of oil in water, and (b) at least one agent that is able to neutralize or reduce the activity of immunosuppressive factors.

2. Composition under item 1, in which the antigenic composition consists predominantly of specified stabilizing detergent, a micelle-forming agent and a biologically compatible oil.

3. Composition under item 1, in which the detergent is selected from the group consisting of TWEEN 80, TWEEN 20, TWEEN 40, TWEEN 60, Zwittergent 3-12, TEEPOL HB7 and SPAN 85.

4. Composition under item 1, in which the specified detergent is added in amount of about 0.05 to 0.5%.

5. The composition according to p. 4, in which the number of the specified detergent is about 0.2%.

6. Composition under item 1, in which the specified micelle-forming agent has a hydrophilic-lipophilic balance of between 0 and 2.

7. The composition according to p. 6, in which the number specified micelle-forming agent is 1.25-5%.

8. Composition under item 1, in which the specified micelle-forming agent selected from the group consisting of poloxamer 401, PLURONIC L62Lf, PLURONIC L101, PLURONIC L64, PEG 1000, TETRONIC 1501, TETRONIC 150R1, TETRONIC 701, TETRONIC 901, TETRONIC 1301 and TETRONIC 130R1.

9. Composition under item 1, in which the number of casapereira melting point below 65C.

11. Composition under item 1, in which the specified oil selected from squalane, eicosane, tetratetracontane, piers and vegetable oils.

12. Composition under item 1, in which the amount of oil is 1-10%.

13. The composition according to p. 12, in which the amount of oil is 2.5-5%.

14. Composition under item 1, in which the detergent is Polysorbate 80, and micelle-forming agent is poloxamer 401.

15. The composition according to p. 14, in which the oil is squalane.

16. Composition under item 1, in which the detergent is selected from the group consisting of TWEEN 20, TWEEN 40 and TWEEN 80, the oil is chosen from the group consisting of squalane, eicosane, olive oil and piers, and micelle-forming agent selected from the group consisting of poloxamer 401 and PLURONIC L62LF.

17. Composition under item 1, in which the specified immunosuppressive factor is TGF.

18. Composition under item 1, in which the specified agent that can neutralize or reduce the activity of immunosuppressive factors secreted by the tumor or by the body-master, is the antibody against TGF, TGFR-protein, similar to TGF, GF-binding protein or TGFR.

20. Composition under item 1, in which the antigenic composition comprises squalene, TWEEN 80, poloxamer 401.

21. Composition under item 1, in which the specified antigen selected from the group consisting of gp100, MART-1/Melan A, gp75, tyrosinase, melanoma of proteoglycan, MAGE, BAGE, GAGE, RAGE, N-acetylglucosaminyltransferase-V, mutated-catenin, mutated MUM-1, mutated cyclin-dependent kinase-4, P21 ras, BCR-abl, p53, p185 HER2/neu, mutated receptor, epidermal growth factor, carcinoembryonic antigens associated with carcinoma of the mutated mucines, products EBNA gene, protein E7 of HPV, E6 protein of human papilloma virus, prostatespecific antigens prostatespecific membrane antigen, RST-1, immunoglobulin idiotypes and idiotypes T-cell receptor.

22. Composition under item 1, which is suitable for the treatment of malignant tumors, viral or parasitic diseases.

23. The method of treatment, which includes the induction response of cytotoxic T-lymphocytes, characterized in that the method includes (i) the introduction of adjuvant, which indecisive factor, described in paragraph 1(b), in which the introduction of adjuvant and antagonist is carried out sequentially or simultaneously and in any order.

24. The method according to p. 23, in which the specified secretively immunosuppressive factor is TGF.

25. The method according to p. 24 which includes the adjuvant and the antagonist is administered consistently.

26. The method according to p. 25, in which the CTL-inducing adjuvant is injected intradermally, intramuscularly or subcutaneously, and the antagonist of TGF injected.

27. The method according to p. 23, in which said treatment includes the treatment of diseases selected from the group consisting of neoplastic tumors or malignant tumors, parasitic infestation and viral infections.

28. The method according to p. 23, wherein said treatment includes restoration or enhancement of hematopoiesis.

29. The method according to p. 27, in which the specified malignant tumor includes breast cancer, malignant brain tumor, cervical cancer, leukemia, lymphoma, prostate cancer, skin cancer, colon cancer, lung cancer, ovarian cancer, pancreatic cancer, malignant tumor of the liver, bladder cancer, kidney cancer, melanoma, myeloma, colorectal cancer or endometrial cancer.

31. The method according to p. 27, in which the specified parasitic infestation including malaria.

32. A method of treating neoplastic conditions or malignant growth, including the introduction of the patient who needs it, (a) a mixture comprising a cancer or a tumor antigen expressed by the specified malignant cells, and microfluidizers antigenic composition, and specified antigenic composition comprises (i) a stabilizing detergent, (ii) a micelle-forming agent, and (iii) biodegradable and biocompatible oil specified antigenic composition is made in the form of a stable emulsion of oil in water, in which the said mixture is introduced to a specified patient in a quantity sufficient for the induction response of cytotoxic T-lymphocytes in a specified patient, which is specific for this cancer or tumor antigen, contained in the above-mentioned mixture, and b) a therapeutically effective amount of at least one agent that is able to neutralize or reduce the activity of immunosuppressive factors secreted by the tumor or by the body-master.

33. With many of proteoglycan, MAGE, BAGE, GAGE, RAGE, N-acetylglucosaminyltransferase-V, mutated-catenin, mutated MUM-1, mutated cyclin-dependent kinase-4, P21 rs, BCR-abl, p53, p185 HER2/neu, mutated receptor, epidermal growth factor, carcinoembryonic antigens associated with carcinoma of the mutated mucines, products EBNA gene, protein E7 of HPV, E6 protein of human papilloma virus, prostatespecific antigens prostatespecific membrane antigen, RST-1, immunoglobulin idiotypes and idiotypes T-cell receptor.

34. A method of treating neoplastic conditions or malignant growth, including the introduction to a patient in need of the composition described in paragraph 1, in a quantity sufficient for the induction response of cytotoxic T-lymphocytes.

35. The way to restore or enhance hematopoiesis, including the introduction of the patient who needs it, (a) a mixture comprising tumor, viral, or parasitic antigen expressed by these tumor infected with viruses or parasites cells, and microfluidizers antigenic composition, and specified antigenic composition comprises (i) a stabilizing detergent, (ii) michellebruno azizia is made in the form of a stable emulsion of oil in water, in which said mixture is introduced to a specified patient in a quantity sufficient for the induction response of cytotoxic T-lymphocytes in a specified patient, which is specific for viral or tumor antigen, contained in the above-mentioned mixture, and b) a therapeutically effective amount of at least one agent that can neutralize or reduce the activity of immunosuppressive factors secreted by the tumor or by the body-master, in which the above mixture and the agent is administered separately or in combination and in any order.

36. The method according to p. 34, wherein the specified antigen selected from the group consisting of gp100, MART-1/Melan A, Dr, tyrosinase, melanoma of proteoglycan, MAGE, BAGE, GAGE, RAGE, M-acetylglucosaminyltransferase-V, mutated-catenin, mutated MUM-1, mutated cyclin-dependent kinase-4, P21 ras, BCR-abl, p53, p185 HER2/neu, mutated receptor, epidermal growth factor, carcinoembryonic antigens associated with carcinoma of the mutated mucines, products EBNA gene, protein E7 of HPV, E6 protein of human papilloma virus, prostatespecific antigens prostatespecific membrane antigen, RST-1, immunoglobulin ideational parasitic antigen, expressing the indicated tumor, infected with a virus or parasite cells, and microfluidizers antigenic composition, and specified antigenic composition comprises (i) a stabilizing detergent, (ii) a micelle-forming agent, and (iii) biodegradable and biocompatible oil, and specified antigenic composition is made in the form of a stable emulsion of oil in water, and (b) one or more antagonists of TGF.

 

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