Claims for Patent: 8,470,775

Summary for Patent: 8,470,775

Title:	Compositions and methods for reducing the risk of preeclampsia
Abstract:	Methods and kits for preventing or reducing the likelihood of implantation failure or miscarriage in a recipient of artificial insemination are provided. The methods include administering into a recipient of artificial insemination in need of such treatment an effective amount of granulocyte colony stimulating factor (G-CSF).
Inventor(s):	Carter; Darryl L. (Owings Mills, MD)
Assignee:	Nora Therapeutics, Inc. (Palo Alto, CA)
Application Number:	13/326,866
Patent Claims:	1. A method for reducing the risk of preeclampsia, 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 about 1 to about 100 mcg (micrograms)/kg/day and wherein the female is at risk of preeclampsia. 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 daily for one to thirty-five consecutive days. 10. The method of claim 1 wherein the G-CSF is administered for four, three, two or one week. 11. The method of claim 1 wherein the G-CSF is administered for five, four, three, two or one day. 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. 15. The method of claim 13 wherein the other active agent is an antihypertensive agent. 16. The method of claim 13 wherein the method further comprises bed rest, monitoring of blood pressure, administering fluids, administering an antihypertensive agent, administering magnesium sulfate, or any combination thereof. 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 or in the post-partum of delivery. 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.

Details for Patent 8,470,775

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
Amgen, Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	12/23/2014		2023-10-24