Treatment with VB-201
AssigneeVascular Biogenics Ltd.
InventorsYael Cohen, Naamit Sher, Itzhak Mendel, Niva Yacov, Eyal Breitbart
Life of this patent
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Abstract
Unit dosage forms comprising between 1 mg and 100 mg VB-201 and a pharmaceutically acceptable carrier, and formulated for oral administration, are disclosed herein, as well as treatment regimens comprising oral administration of VB-201 once or twice daily for treating an inflammatory disease or disorder.
Claims23
-56. (canceled)
A method of treating or preventing an inflammatory disease or disorder associated with an endogenous oxidized lipid comprising orally administering to a human in need thereof a unit dosage form comprising VB-201 or a pharmaceutically acceptable salt thereof, wherein if administered to a human daily for 14 consecutive days, the unit dosage form has a pharmacokinetic profile of VB-201 in plasma having one or more characteristics selected from the group consisting of:
- a) an AUC(0-24h) of from 3,875 to 8,601 ng·h/mL, from 8,829 to 16,405 ng·h/mL, from 11,212 to 29,894 ng·h/mL, from 19,816 to 41,294 ng·h/mL, from 30,601 to 64,185 ng·h/mL or from 68,028 to 111,530 ng·h/mL;
- wherein the AUC(0-24h) is measured on day 14;
- b) a Cmax of from 218.17 to 462.45 ng/mL, from 476.21 to 855.39 ng/mL, from 701.14 to 1,850.16 ng/mL, from 1,093.41 to 2,549.39 ng/mL, from 1,744.10 to 3,345.10 ng/mL or from 3,889.90 to 5,750.5 ng/mL;
- wherein the Cmax of VB-201 is measured on day 14;
- c) an AUC(0-24h) of from 916 to 2,546 ng·h/mL, from 1,812 to 5,176 ng·h/mL, from 2,751 to 5,621 ng·h/mL, from 3,162 to 9,656 ng·h/mL or from 4,388 to 7,578 ng·h/mL, wherein the AUC(0-24h) is measured on day 1;
- and
- d) a Cmax of from 79.72 to 154.96 ng/mL, from 147.56 to 308.28 ng/mL, from 183.50 to 404.96 ng/mL, from 213.76 to 619.40 ng/mL or from 636.30 to 1211.10 ng/mL;
- wherein the Cmax of VB-201 is measured on day 1.
A unit dosage form comprising VB-201 or a pharmaceutically acceptable salt thereof, wherein if administered to a human daily for 14 consecutive days, the unit dosage form has a pharmacokinetic profile of VB-201 in plasma having one or more characteristics selected from the group consisting of:
- a) an AUC(0-24h) of from 3,875 to 8,601 ng·h/mL, from 8,829 to 16,405 ng·h/mL, from 11,212 to 29,894 ng·h/mL, from 19,816 to 41,294 ng·h/mL, from 30,601 to 64,185 ng·h/mL, or from 68,028 to 111,530 ng·h/mL;
- wherein the AUC(0-24h) is measured on day 14;
- b) a Cmax of from 218.17 to 462.45 ng/mL, from 476.21 to 855.39 ng/mL, from 701.14 to 1,850.16 ng/mL, from 1,093.41 to 2,549.39 ng/mL, from 1,744.10 to 3,345.10 ng/mL, or from 3,889.90 to 5,750.5 ng/mL;
- wherein the Cmax of VB-201 is measured on day 14;
- an AUC(0-24h) of from 916 to 2,546 ng·h/mL, from 1,812 to 5,176 ng·h/mL, from 2,751 to 5,621 ng·h/mL, from 3,162 to 9,656 ng·h/mL, or from 4,388 to 7,578 ng·h/mL, wherein the AUC(0-24h) is measured on day 1;
- and
- d) a Cmax of from 79.72 to 154.96 ng/mL, from 147.56 to 308.28 ng/mL, from 183.50 to 404.96 ng/mL, from 213.76 to 619.40 ng/mL or from 636.30 to 1211.10 ng/mL;
- wherein the Cmax of VB-201 is measured on day 1.
Dependencies are inferred from the claim text.