USE OF IL-12 TO INCREASE SURVIVAL
The present invention provides methods for increasing survival in a subject, and/or preserving bone marrow function, and/or promoting hematopoietic recovery or restoration. The methods include administering a dose of IL-12 to the subject following an acute exposure to non-therapeutic whole body ionizing radiation. Formulations and kits are also provided.
1 - 27 . (canceled)
28 . A kit for increasing survival in a subject, and/or preserving bone marrow function, and/or promoting hematopoietic recovery or restoration following non-therapeutic acute exposure to whole body ionizing radiation,
the kit comprising one or more formulations of a therapeutically effective dose of Interleukin-12 (IL-12).
29 . The kit of claim 28 , wherein the kit is for increasing survival in a human subject, wherein the therapeutically effective dose of IL-12 is between from about 25.66 μg to about 1.71 μg.
30 . The kit of claim 28 , wherein the kit is for increasing survival in a human subject, wherein the therapeutically effective dose of IL-12 is less than about 17.11 μg.
31 . The kit of claim 28 , wherein the kit is for increasing survival in a human subject, wherein the therapeutically effective dose of IL-12 is less than about 13.68 μg.
32 . The kit of claim 28 , wherein the IL-12 is formulated for intravenous, intramuscular, intraperitoneal, intracerebrospinal, subcutaneous, intra-articular, intrasynovial, or intrathecal administration.
33 . The kit of claim 28 , wherein the IL-12 is formulated for injection in solution or as a lyophilized powder.
34 . The kit of claim 28 , wherein the IL-12 is recombinant IL-12.
35 . The kit of claim 34 , wherein the IL-12 is recombinant human IL-12 (rhIL-12).
36 . The kit of claim 38 , wherein the rhIL-12 is HemaMax™.
37 . The kit of claim 28 , wherein the IL-12 is modified so as to reduce the immunogenicity of the protein.
38 . The kit of claim 37 , wherein the IL-12 protein is modified with one or more water-soluble polymers.
39 . The kit of claim 28 , wherein the IL-12 is formulated in a tube, vial or syringe.
40 . The kit of claim 28 , wherein the IL-12 is administered with a carrier molecule or bulking agent.
41 . The kit of claim 40 , wherein the carrier molecule is an albumin.
42 . The kit of claim 40 , wherein the carrier molecule is present at a concentration of at least about two times the concentration of IL-12.
43 . The kit of claim 28 , comprising multiple unit doses of IL-12.
44 . The kit of claim 28 , further comprising a compound useful for supportive care of IL-12 treatment following radiation exposure selected from the group consisting of antibiotics, hematopoietic growth factors, G-CSF, IL-3, erythropoietin, erythropoietin-like molecules, IL-1, IL-4, IL-5, IL-6, IL-7, IL-11, and any combination thereof.
45 . The kit of claim 28 , wherein the IL-12 is housed in a radiation proof or radiation resistant container.