1. A monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein the epitope comprises the amino acid sequence Glu-Val-His-Leu-Lys-Leu-His-Gly-Glu-Lys-Gln-Gly-Thr-Gln (SEQ ID NO:1).
2. The monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein the epitope consists of amino acid sequence His-Gly-Glu-Lys-Gln-Gly-Thr-Gln (SEQ ID NO:2).
3. The monoclonal antibody of claim 1, wherein a light chain of the monoclonal antibody comprises SEQ ID NO:5.
4. The monoclonal antibody of claim 1, wherein a heavy chain of the monoclonal antibody comprises SEQ ID NO:6.
5. A composition comprising a monoclonal antibody, wherein the composition comprises monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein the epitope consists of SEQ ID NO:1.
6. The composition of claim 5, wherein the antibody comprises a light chain comprising SEQ ID NO:5.
7. The composition of claim 5, wherein the antibody comprises a heavy chain comprising SEQ ID NO:6.
8. The composition of claim 5, wherein the composition further comprises a pharmaceutically acceptable carrier.
9. A method of inhibiting osteoclastogenesis in a DC-STAMP expressing osteoclast precursor cell, the method comprising administering to the cell the composition of claim 5.
10. The method of claim 9, wherein the composition is administered in vitro.
11. The method of claim 9, wherein the cell is a mammalian cell.
12. The method of claim 11, wherein the mammalian cell is a human cell.
13. The method of claim 9, wherein the composition is administered to a subject in vivo.
14. The method of claim 13, wherein the composition further comprises a pharmaceutically acceptable carrier.
15. A monoclonal antibody that specifically binds to an epitope of DC-STAMP, wherein a heavy chain of the antibody comprises SEQ ID NO: 6 or all complementarity determining regions (CDRs) thereof and a light chain of the antibody comprises SEQ ID NO: 5 or all CDRs thereof.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A method of administering pirfenidone to a human patient in need thereof comprising administering to the patient (1) food and (2) a pharmaceutical composition comprising a therapeutically effective dose of pirfenidone, wherein the ratio of the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to the patient under fed conditions (Cmax(fed)) to the mean maximum plasma concentration of pirfenidone when said pharmaceutical composition is administered to said patient under fasted conditions (Cmax(fasted)) is about 0.35 to about 0.7.
2. The method of claim 1, wherein the total daily amount of pirfenidone administered to the patient is about 2403 mg.
3. The method of claim 1, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
4. The method of claim 1, wherein the ratio of the mean absorption half life of pirfenidone when said pharmaceutical composition is administered to the patient under fed conditions (t12, abs(fed)) to the mean absorption half life of pirfenidone when said pharmaceutical composition is administered to the patient under fasted conditions t12, abs(fasted)) is about 2.5 to about 3.5.
5. The method of claim 4, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
6. The method of claim 3, wherein the total daily amount of pirfenidone administered to the patient is about 2403 mg.
7. The method of claim 1, wherein the administration of the food is within one hour of the administration of the pirfenidone.
8. The method of claim 1, further comprising advising the patient that taking pirfenidone under fed conditions may reduce the incidence of adverse events resulting from pirfenidone therapy in comparison to taking pirfenidone under fasted conditions.
9. The method of claim 8, wherein the adverse event comprises one of more of dizziness, somnolence, or headaches.
10. A method of providing pirfenidone therapy to a human patient in need thereof comprising advising the patient that the mean maximum plasma concentration of pirfenidone when administered under fed conditions (Cmax(fed)) is lower than the mean maximum plasma concentration of pirfenidone when administered under fasted conditions (Cmax(fasted)), wherein the ratio of Cmax(fed):Cmax(fasted) is about 0.35 to about 0.7.
11. The method of claim 10, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
12. The method of claim 10 further comprising advising the patient that the mean absorption half-life of pirfenidone under fed conditions (t12, abs(fed)) is longer than the mean absorption half-life of pirfenidone under fasted conditions (t12, abs(fasted)), wherein the ratio t12, abs(fed):t12, abs(fasted) is about 2.5 to about 3.5.
13. The method of claim 12, wherein the area under the curve of the absorption curve of pirfenidone when administered under fed conditions (AUCfed) is at least about 80% of the area under the curve of the absorption curve of pirfenidone when administered under fasted conditions (AUCfasted).
14. The method of claim 11 further comprising advising the patient that taking pirfenidone under fed conditions may reduce the incidence of adverse events resulting from pirfenidone therapy in comparison to taking pirfenidone under fasted conditions.
15. The method of claim 14, wherein the adverse event comprises one or more of dizziness, somnolence, or headaches.
16. The method of claim 10, further advising the patient to take a total daily amount of pirfenidone of about 2403 mg.