Claims for Patent: 8,481,488

Summary for Patent: 8,481,488

Title:	Compositions and methods for reducing the risk of preterm labor
Abstract:	The present invention provides compositions, kits and methods for the prevention of spontaneous abortion or implantation failure during assisted reproduction. The compositions, kits and methods provide an effective amount of granulocyte colony stimulating factor to prevent spontaneous abortion or implantation failure of an embryo. The present invention also provides compositions, kits and methods for the treatment or prevention of preeclampsia and preterm labor.
Inventor(s):	Carter; Darryl (Owings Mills, MD)
Assignee:	Nora Therapeutics Inc. (Palo Alto, CA)
Application Number:	13/458,823
Patent Claims:	1. A method for reducing the risk of preterm labor, comprising administering to a human female an effective amount of a granulocyte colony stimulating factor (G-CSF), wherein the G-CSF is administered at a dose ranging from 1 to 100 mcg (micrograms)/kg/day for a plurality of days, and wherein the human female is at risk of preterm labor. 2. The method of claim 1 wherein the G-CSF is administered at a dose ranging from 1 mcg/kg/day to 20 mcg/kg/day. 3. The method of claim 1 wherein the G-CSF is administered at a dose ranging from 1 mcg/kg/day to 10 mcg/kg/day. 4. The method of claim 1 wherein the G-CSF is filgrastim or pegfilgrastim. 5. The method of claim 1 wherein the G-CSF is administered in the second trimester of pregnancy, third trimester of pregnancy, or both. 6. The method of claim 1 wherein the G-CSF is administered before the second or third trimester of pregnancy. 7. The method of claim 1 wherein the G-CSF is administered through the end of pregnancy. 8. The method of claim 1 wherein the G-CSF is administered for the duration of pregnancy. 9. The method of claim 1 wherein the G-CSF is administered for four, three, two or one week. 10. The method of claim 1 wherein the G-CSF is administered for five, four, three, or two days. 11. The method of claim 1 wherein the G-CSF is administered about two days, about three days, about four days, about one week, about two weeks or up to about eight weeks, following signs of preterm labor. 12. The method of claim 1 wherein the G-CSF is administered parenterally, enterally, subcutaneously, percutaneously, transdermally, intradermally, intravenously, topically, by inhalation, or by implantation. 13. The method of claim 1 wherein the G-CSF is administered with another active agent. 14. The method of claim 13 wherein the other active agent is an immunosuppressive agent or an anti-inflammatory agent. 15. The method of claim 13 wherein the other active compound is vitamin D or aspirin. 16. The method of claim 13 wherein the other active compound is heparin, intravenous immunoglobulin (IVIG) or progesterone. 17. The method of claim 1 wherein the G-CSF is formulated as a composition comprising a pharmaceutically acceptable carrier or diluent. 18. The method of claim 1 wherein the G-CSF is formulated for prolonged delivery. 19. The method of claim 18 wherein the prolonged delivery results from a formulation comprising G-CSF conjugated to a water soluble polymer. 20. The method of claim 19 wherein the G-CSF conjugated to a water soluble polymer is pegfilgrastim. 21. The method of claim 18 wherein the G-CSF is formulated for prolonged delivery with a polymeric or a hydrophobic material. 22. The method of claim 18 wherein the prolonged delivery formulation comprises an inert matrix or device. 23. The method of claim 18 wherein the prolonged delivery formulation comprises an adhesive disc or patch capable of slowly releasing G-CSF for percutaneous, transdermal, or intradermal adsorption. 24. The method of claim 23 wherein the disc or patch further comprise a skin permeation enhancer. 25. The method of claim 1 wherein the human female is in the second or third trimester of pregnancy. 26. The method of claim 1 wherein the human female was a recipient of an assisted reproduction procedure. 27. The method of claim 26 wherein the assisted reproduction procedure is in vitro fertilization, artificial insemination, or gamete intrafallopian tube transfer. 28. The method of claim 1 wherein the G-CSF is administered subcutaneously. 29. A method for reducing the risk of preterm labor, comprising administering to a human female at risk of preterm labor an effective amount of a granulocyte colony stimulating factor (G-CSF), wherein the G-CSF is administered at a dose ranging from 1 to 100 mcg (micrograms)/kg/day formulated for prolonged delivery. 30. The method of claim 29 wherein the G-CSF is administered at a dose ranging from 1 mcg/kg/day to 20 mcg/kg/day. 31. The method of claim 29 wherein the G-CSF is administered at a dose ranging from 1 mcg/kg/day to 10 mcg/kg/day. 32. The method of claim 29 wherein the G-CSF is filgrastim or pegfilgrastim. 33. The method of claim 29 wherein the G-CSF is administered in the second trimester of pregnancy, third trimester of pregnancy, or both. 34. The method of claim 29 wherein the G-CSF is administered before the second or third trimester of pregnancy. 35. The method of claim 29 wherein the G-CSF is administered through the end of pregnancy. 36. The method of claim 29 wherein the G-CSF is administered for the duration of pregnancy. 37. The method of claim 29 wherein the G-CSF is administered for four, three, two or one week. 38. The method of claim 29 wherein the G-CSF is administered for five, four, three, two or one day. 39. The method of claim 29 wherein the G-CSF is administered about one day, about two days, about three days, about four days, about one week, about two weeks and up to about eight weeks, following signs of preterm labor. 40. The method of claim 29 wherein the G-CSF is administered parenterally, enterally, subcutaneously, percutaneously, transdermally, intradermally, intravenously, topically, by inhalation, or by implantation. 41. The method of claim 29 wherein the G-CSF is administered subcutaneously. 42. The method of claim 29 wherein the G-CSF is administered with another active agent. 43. The method of claim 42 wherein the other active agent is an immunosuppressive agent or an anti-inflammatory agent. 44. The method of claim 42 wherein the other active compound is vitamin D or aspirin. 45. The method of claim 42 wherein the other active compound is heparin, intravenous immunoglobulin (IVIG) or progesterone. 46. The method of claim 29 wherein the prolonged delivery formulation comprises a pharmaceutically acceptable carrier or diluent. 47. The method of claim 29 wherein the prolonged delivery formulation comprises G-CSF conjugated to a water soluble polymer. 48. The method of claim 29 wherein the G-CSF conjugated to a water soluble polymer is pegfilgrastim. 49. The method of claim 29 wherein the prolonged delivery formulation comprises a polymeric or a hydrophobic material. 50. The method of claim 29 wherein the prolonged delivery formulation comprises an inert matrix or device. 51. The method of claim 29 wherein the prolonged delivery formulation comprises an adhesive disc or patch capable of slowly releasing G-CSF for percutaneous, transdermal, or intradermal adsorption. 52. The method of claim 51 wherein the disc or patch further comprise a skin permeation enhancer. 53. The method of claim 29 wherein the human female was a recipient of an assisted reproduction procedure. 54. The method of claim 53 wherein the assisted reproduction procedure is in vitro fertilization, artificial insemination, or gamete intrafallopian tube transfer.

Details for Patent 8,481,488

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2023-10-24
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000		2023-10-24
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031	01/31/2002		2023-10-24