Interleukin-10 compositions for the treatment of adenocarcinomas
View Patent ↗The present invention is directed to methods for the treatment of adenocarcinomas that are characterized by the overexpression of a particular oncogene, Pim-1. The procedure involves administering a therapeutically effective amount of interleukin-10 that has been coupled to a carrier that increases its circulating plasma half-life.
1. A method of treating a patient for an adenocarcinoma of the colon which does not occur subsequent to an inflammatory bowel disease and which overexpresses the Pim-1 oncogene, comprising administering to said patient an effective amount of a chimeric protein in which human IL10 is fused to the Fc region of a human IgG and wherein said chimeric protein has a circulating plasma half-life that is at least twice as long as free human IL10.
2. The method of claim 1 , wherein said human IgG is human IgG2a.
3. The method of claim 1 , wherein said chimeric protein further comprises the hinge region of IgG and said IL10 is fused to said hinge region.
4. The method of claim 1 , wherein said chimeric protein has a circulating plasma half-life of at least four hours.
5. The method of claim 1 , wherein said chimeric protein is administered to said patient by injection or infusion at a dose of 0.5 μg/kg body weight to 50 μg/kg body weight.
6. The method of claim 1 , wherein said Fc region of said human IgG is non-lytic.
7. The method of claim 1 , wherein said chimeric protein is administered to said patient by injection or infusion at a dose of 0.5-5 mg.
8. The method of claim 1 , wherein:
a) said human IgG is human IgG2a;
b) said chimeric protein further comprises the hinge region of IgG and said IL10 is fused to said hinge region; and
c) said chimeric protein has a circulating plasma half-life of at least four hours.
9. The method of claim 8 , wherein said Fc region of said human IgG is non-lytic.
10. The method of claim 9 , wherein said chimeric protein is administered to said patient by injection or infusion at a dose of 0.5-5 mg.
11. A method of treating a patient for an adenocarcinoma of the colon which does not occur subsequent to an inflammatory bowel disease, comprising:
a) assaying a biological sample from said patient to determine if said adenocarcinoma is producing more Pim-1 oncogene than the amount produced by normal tissue of the same organ; and
b) if the results of the assay of step a) indicate that said adenocarcinoma is producing greater than normal amounts of said Pim-1 oncogene, administering to said patient a pharmaceutical composition comprising an effective amount of a chimeric protein in which human IL10 is fused to the Fc region of a human IgG and wherein said chimeric protein has a circulating plasma half-life that is at least twice as long as free human IL10.
12. The method of claim 11 , wherein said chimeric protein has a circulating plasma half-life of at least four hours.
13. The method of claim 12 , wherein said chimeric protein is administered at a dosage of between 0.5 μg/kg body weight and 50 μg/kg body weight.
14. The method of claim 11 , wherein said human IgG is human IgG2a.
15. The method of claim 14 , wherein said chimeric protein further comprises the hinge region of IgG and said IL10 is fused to said hinge region.
16. The method of claim 15 , wherein said Fc region of said human IgG is non-lytic.
17. The method of claim 16 , wherein said chimeric protein has a circulating plasma half-life of at least four hours.
18. The method of claim 17 , wherein said chimeric protein is administered to said patient by injection or infusion at a dose of 0.5 μg/kg body weight to 50 μg/kg body weight.
19. The method of claim 18 , wherein said chimeric protein is administered to said patient by injection or infusion at a dose of 0.5-5 mg.
20. The method of claim 18 , wherein the assay of step a) is an ELISA assay.