Transplantation Therapies
Embodiments of the present invention are directed to methods and dosage forms for treating inflammation and rejection in transplantation injuries with Bryostatin-1, Bryostatin-1 analogs and pharmaceutically acceptable salts thereof.
1 - 2 . (canceled)
3 . The method of claim 43 wherein said effective amount of Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is an amount to achieve a plasma concentration in an individual being treated for graft versus host disease about 10 −7 M.
4 . The method of claim 43 wherein said effective amount of Bryostatin-1, Bryostatin-1 analog or a pharmaceutically acceptable salt thereof is held in a dosage form.
5 . The method of claim 43 wherein said dosage form is an oral dosage form.
6 . The method of claim 5 wherein said oral dosage form is a solid oral dosage form.
7 . (canceled)
8 . The method of claim 43 wherein said polyalkylene glycol glyceride is a mixture of polyalkylene esters of one or more eight carbons to eighteen carbons saturated fatty acids with glycerol.
9 . The method of claim 8 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1000 to 2000 daltons.
10 . The method of claim 9 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1400 to 1600 daltons.
11 . The method of claim 5 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said oral dosage form in an amount of 1 to 30% by weight.
12 . The method of claim 5 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said oral dosage form in an amount of 10 to 20% by weight.
13 . The method of claim 5 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said oral dosage form in an amount of 2 to 25% by weight.
14 . The method of claim 4 wherein said dosage form is a pharmaceutical parenteral formulation.
15 . (canceled)
16 . The method of claim 43 wherein said polyalkylene glycol glyceride is a mixture of polyalkylene esters of one or more eight carbons to eighteen carbons saturated fatty acids with glycerol.
17 . The method of claim 43 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1000 to 2000 daltons.
18 . The method of claim 17 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1400 to 1600 daltons.
19 - 22 . (canceled)
23 . The method of claim 43 wherein said graft versus host disease is in humans.
24 . (canceled)
25 . The dosage form of claim 44 wherein said dosage form is a solid oral dosage form.
26 . (canceled)
27 . The dosage form of claim 44 wherein said polyalkylene glycol glyceride is a mixture of polyalkylene esters of one or more eight carbons to eighteen carbons saturated fatty acids with glycerol.
28 . The dosage form of claim 27 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1000 to 2000 daltons.
29 . The dosage form of claim 28 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1400 to 1600 daltons.
30 . The dosage form of claim 25 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said oral dosage form in an amount of 1 to 30% by weight.
31 . The dosage form of claim 25 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said oral dosage form in an amount of 10 to 20% by weight.
32 . The dosage form of claim 25 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said oral dosage form in an amount of 2 to 25% by weight.
33 . The dosage form of claim 44 wherein said dosage form is a pharmaceutical parenteral formulation.
34 . (canceled)
35 . The dosage form of claim 33 wherein said polyalkylene glycol glyceride is a mixture of polyalkylene esters of one or more eight carbons to eighteen carbons saturated fatty acids with glycerol.
36 . The dosage form of claim 35 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1000 to 2000 daltons.
37 . The dosage form of claim 36 wherein said polyalkylene glycol is a polyethylene glycol having a molecular weight of 1400 to 1600 daltons.
38 . The dosage form of claim 33 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said pharmaceutical formulation in an amount of 0.0005 to 0.5% by weight.
39 . The dosage form of claim 2 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said pharmaceutical formulation in an amount of 0.001 to 0.1% by weight.
40 . The dosage form of claim 33 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said pharmaceutical parenteral formulation in an amount of 0.001 to 0.1% by weight.
41 . The dosage form of claim 3 wherein said Bryostatin-1, Bryostatin-1 analog or pharmaceutically acceptable salt thereof is present in said pharmaceutical parenteral formulation as a dispersion in water having a concentration of 0.0005 to 0.1% by weight.
42 . (canceled)
43 . A method of treating graft vs. host disease (GVHD) by controlling inflammatory reactions in host cells following transplantation, comprising administering an effective amount of Bryostatin-1, Bryostatin-1 analog or a pharmaceutically acceptable salt thereof to reduce or prevent induced neutrophil trans endothelial migration, and wherein said dosage form comprises polyalkylene glycol glyceride.
44 . A dosage form for treating graft vs. host disease (GVHD) by controlling inflammatory reactions in host cells following transplantation, comprising administering an effective amount of Bryostatin-1, Bryostatin-1 analog or a pharmaceutically acceptable salt thereof to reduce or prevent induced neutrophil trans endothelial migration wherein said dosage form is for administration to a human or animal in need thereof, wherein said dosage form comprises saturated polyalkylene glycol glyceride, and wherein said effective amount in the organ is a plasma concentration of about 10 −7 M.
45 . A method of reducing GVHD-related inflammatory reactions due to migration of adaptive immune cells into surrounding tissues following bone marrow transplantation, comprising administering Bryostatin-1 in an effective amount.