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US 2022/0088030 A1Published application
Methods for treatment of diseases
AssigneeGalera Labs, LLC
InventorsJeffery L. KEENE, Dennis P. RILEY, Robert A. BEARDSLEY
Life of this patent
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Abstract
The present disclosure relates to methods of treating a range of diseases or conditions. The methods involve administration of a superoxide dismutase mimetic.
Claims41
1:
- A unit dose formulation comprising at least 50 mg of a superoxide dismutase mimetic in a container, the superoxide dismutase mimetic corresponding to Formula (GC4419):
- wherein X and Y are independently neutral or negatively-charged ligands.
2:
- The unit dose formulation of claim 1, which comprises at least 600 mg of the superoxide dismutase mimetic.
3:
- The unit dose formulation of claim 1, wherein the superoxide dismutase mimetic is in the form of a lyophilized powder.
4:
- The unit dose formulation of claim 1, wherein the container further includes a pharmaceutically acceptable carrier.
5:
- The unit dose formulation of claim 4, wherein the pharmaceutically acceptable carrier comprises a buffered saline solution.
6:
- The unit dose formulation of claim 4, wherein the pharmaceutically acceptable carrier comprises a bicarbonate-buffered saline solution.
7:
- The unit dose formulation of claim 1, wherein X and Y are independently selected from monodentate ligands.
8:
- The unit dose formulation of claim 1, wherein X and Y are independently selected from the group consisting of aquo ligands, halo ligands, carboxylato ligands, and bicarbonato ligands.
9:
- The unit dose formulation of claim 8, wherein X and Y are chloro ligands.
10:
- The unit dose formulation of claim 1, wherein the formulation is stored in a container for storage or for administration to a patient.
11:
- The unit dose formulation of claim 10, wherein the container is a vial, a syringe, or an IV bag or bottle.
12:
- A method of treating a disease or condition in a human patient, the method comprising administering to the patient at least 25 mg of a superoxide dismutase mimetic at a rate of at least 100 mg/hr, wherein the superoxide dismutase mimetic corresponds to Formula (GC4419):
- and X and Y are independently neutral or negatively-charged ligands.
13:
- The method of claim 12, wherein the superoxide dismutase mimetic is administered at a rate of at least 600 mg/hr.
14:
- The method of claim 12, wherein at least 50 mg of the superoxide dismutase mimetic is administered to the patient.
15:
- The method of claim 12, wherein at least 600 mg of the superoxide dismutase mimetic is administered to the patient.
16:
- The method of claim 12, wherein the administration occurs within a 15 minute time period.
17:
- The method of claim 12, wherein the administration occurs within a 60 minute time period.
18:
- The method of claim 12, wherein the superoxide dismutase mimetic is administered parenterally.
19:
- The method of claim 12, wherein the superoxide dismutase mimetic is administered intravenously.
20:
- The method of claim 12, wherein the superoxide dismutase mimetic is administered as a pharmaceutical composition comprising the superoxide dismutase mimetic corresponding to Formula (GC4419) and a pharmaceutically acceptable carrier.
21:
- The method of claim 12, wherein the superoxide dismutase mimetic is administered in the form of the unit dose formulation of claim 1.
22:
- The method of claim 12, wherein the superoxide dismutase mimetic is dissolved in a solution comprising about 0.25 mg/mL to about 3.5 mg/mL superoxide dismutase mimetic and contained in an IV bag.
23:
- The method of claim 12, wherein X and Y are independently selected from monodentate ligands.
24:
- The method of claim 12, wherein X and Y are independently selected from the group consisting of aquo ligands, halo ligands, carboxylato ligands, and bicarbonato ligands.
25:
- The method of claim 24, wherein X and Y are chloro ligands.
26:
- A method of treating a disease or condition in a human patient, the method comprising administering to the patient a superoxide dismutase mimetic to provide an exposure as measured by an area under the curve (AUC) of at least 4,000 ng-h/mL as calculated from the measurement of the superoxide dismutase mimetic concentration in the patient's plasma, wherein the superoxide dismutase mimetic corresponds to Formula (GC4419):
- and X and Y are independently neutral or negatively-charged ligands.
27:
- The method of claim 26, wherein the administration provides an exposure as measured by an area under the curve (AUC) of at least 50,000 ng-h/mL as calculated from the measurement of the superoxide dismutase mimetic concentration in the patient's plasma.
28:
- The method of claim 26, wherein the superoxide dismutase mimetic is administered parenterally.
29:
- The method of claim 26, wherein the superoxide dismutase mimetic is administered intravenously.
30:
- The method of claim 26, wherein the superoxide dismutase mimetic is administered as a pharmaceutical composition comprising the superoxide dismutase mimetic corresponding to Formula (GC4419) and a pharmaceutically acceptable carrier.
31:
- The method of claim 26, wherein the superoxide dismutase mimetic is administered in the form of the unit dose formulation of claim 1.
32:
- The method of claim 26, wherein the superoxide dismutase mimetic is dissolved in a solution comprising about 0.25 mg/mL to about 3.5 mg/mL superoxide dismutase mimetic and contained in an IV bag.
33:
- The method of claim 26, wherein X and Y are independently selected from monodentate ligands.
34:
- The method of claim 26, wherein X and Y are independently selected from the group consisting of aquo ligands, halo ligands, carboxylato ligands, and bicarbonato ligands.
35:
- The method of claim 34, wherein X and Y are chloro ligands.
36:
- An article of manufacture, comprising packaging material and contained within said packaging material a parenteral formulation for treating a disease or condition or for protecting tissue against damage resulting from exposure to a cancer treatment in a patient in need thereof, wherein said parenteral formulation comprises a unit dose formulation of any of claims 1-20 and wherein said packaging material comprises a label or package insert with instructions for parenterally administering the dose to the patient.
37:
- The article of manufacture of claim 36, wherein the parenteral formulation is in solution form, comprising about 20 mg/mL superoxide dismutase mimetic, the formulation being a unit dose in a container.
38:
- The article of manufacture of claim 36, wherein the parenteral formulation is in solution form, comprising about 5 mg/mL superoxide dismutase mimetic, the formulation being a unit dose in a container.
39:
- The method of claim 36, wherein X and Y are independently selected from monodentate ligands.
40:
- The method of claim 36, wherein X and Y are independently selected from the group consisting of aquo ligands, halo ligands, carboxylato ligands, and bicarbonato ligands.
41:
- The method of claim 40, wherein X and Y are chloro ligands.