Claims for Patent: 9,084,759

Summary for Patent: 9,084,759

Title:	Methods for reducing the risk of spontaneous abortion in a human female comprising administering an effective amount of G-CSF
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:	13/924,823
Patent Claims:	1. A method for reducing the risk of spontaneous abortion, comprising administering an effective amount of a granulocyte colony stimulating factor (G-CSF) to a human female at risk of a spontaneous abortion, wherein the G-CSF has an increased half-life and is administered at a dose ranging from about 1 .mu.g/kg/day to about 100 .mu.g/kg/day during the first 20 weeks of pregnancy. 2. The method according to claim 1, wherein the G-CSF having an increased half-life is administered parenterally, enterally, subcutaneously, percutaneously, transdermally, intradermally, intravenously, topically, by inhalation, or by implantation. 3. The method according to claim 2, wherein the assisted reproduction procedure is in vitro fertilization, artificial insemination, or gamete intrafallopian tube transfer. 4. The method according to claim 1, wherein the G-CSF having an increased half-life is administered subcutaneously. 5. The method according to claim 1, wherein the human female was a recipient of an assisted reproduction procedure. 6. The method according to claim 1, wherein the G-CSF having an increased half-life is administered at a dose ranging from 1 .mu.g/kg/day to 20 .mu.g/kg/day. 7. The method according to claim 1, wherein the dose is administered daily or is administered daily through the 20.sup.th week of pregnancy. 8. The method according to claim 1, wherein the dose is administered for one day, two days, three days, four days, one week, two weeks, three weeks, or four weeks. 9. The method according to claim 1, wherein the dose is administered daily for four weeks, three weeks, two weeks, or one week during the first trimester of pregnancy. 10. The method according to claim 1, wherein the dose is administered daily for four weeks, three weeks, two weeks, or one week during the second trimester of pregnancy. 11. The method according to claim 1, wherein the dose is administered for at least five consecutive days during the first or second trimester of pregnancy. 12. The method according to claim 1, wherein the dose is administered for at least five consecutive days during the first or second week of pregnancy. 13. The method according to claim 1, wherein the dose is administered through the second trimester of pregnancy. 14. The method according to claim 1, wherein the G-CSF having an increased half-life is administered with another active agent. 15. The method according to claim 14, wherein the other active agent is an immunosuppressive agent, an anti-inflammatory agent, vitamin D, aspirin, heparin, intravenous immunoglobulin (IVIG), or progesterone. 16. The method according to claim 1, wherein the G-CSF having an increased half-life is formulated as a composition comprising a pharmaceutically acceptable carrier or diluent. 17. The method according to claim 1, wherein the G-CSF having an increased half-life comprises filgrastim, nartograstim, or lenograstim. 18. The method according to claim 1, wherein the G-CSF having an increased half-life comprises a G-CSF fusion protein, a G-CSF hybrid, or a G-CSF conjugated to a water soluble polymer. 19. The method according to claim 18, wherein the G-CSF having an increased half-life is a G-CSF conjugated to a water soluble polymer, wherein the water soluble polymer comprises one or more polyethylene glycol molecules. 20. The method according to claim 18, wherein the G-CSF having an increased half-life is a G-CSF conjugated to a water soluble polymer, wherein the G-CSF comprises filgrastim, nartograstim, or lenograstim. 21. The method according to claim 18, wherein the G-CSF conjugated to a water soluble polymer is pegfilgrastim. 22. The method according to claim 1, wherein the human female is in the first trimester of pregnancy, or is in the first or second month of pregnancy. 23. The method according to claim 1, wherein the human female previously had one or more spontaneous abortions, two or more spontaneous abortions, or recurrent spontaneous abortions.

Details for Patent 9,084,759

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2039-02-26
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000		2039-02-26
Amgen, Inc.	NEULASTA	pegfilgrastim	Injection	125031	01/31/2002		2039-02-26
Amgen, Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	12/23/2014		2039-02-26