Claims for Patent: 7,407,931

Summary for Patent: 7,407,931

Title:	Method of treating Crohn\'s Disease using sargramostim
Abstract:	Immune stimulatory amounts of hematopoietic colony stimulating factors are administered to patients with inflammatory bowel disease. The factors include G-CSF and GM-CSF. These factors induce and maintain remission of the disease and its manifestations, whether within the intestine or without.
Inventor(s):	Dieckgraefe; Brian K. (Chesterfield, MO), Korzenik; Joshua (St. Louis, MO)
Assignee:	Washington University (St. Louis, MO)
Application Number:	11/099,461
Patent Claims:	1. A method of treating Crohn's Disease comprising: administering to a patient with Crohn's Disease not associated with Glycogen Storage Disease 1b an immune stimulatory amount of sargramostim. 2. A method of treating Crohn's Disease comprising: administering to a patient with Crohn's Disease not associated with Chronic Granulomatous Disease an immune stimulatory amount of sargramostim. 3. A method of treating Crohn's Disease comprising: administering to a patient with Crohns Disease not associated with a presently characterized and identifiable specific neutrophil disorder caused by a genetic disease an immune stimulatory amount of sargramostim. 4. The method of claim 1 wherein the Crohn's Disease is also not associated with Chronic Granulomatous Disease. 5. The method of claim 1, 2, 3 , or 4 wherein the patient has mucosal inflammation of at least one of the small intestine, colon, or rectum, and the immune stimulatory amount of sargramostim is an amount sufficient to reduce the mucosal inflammation. 6. The method of claim 5 wherein the immune stimulatory amount of sargramostim is an amount sufficient to induce remission of the mucosal inflammation disease. 7. The method of claim 1, 2, 3 , or 4 wherein the patient has epithelial damage of at least one of the small intestine, colon, or rectum, and the amount of colony stimulating factor administered is sufficient to repair the epithelial damage. 8. The method of claim 1, 2, 3, or 4 wherein the immune stimulatory amount of Sargramostim is sufficient to reduce the patient's symptoms. 9. The method of claim 1, 2, 3, or 4 wherein the patient has a fistula or a perianal abscess, and the amount of colony stimulating factor administered is sufficient to reduce the fistula or perianal abscess. 10. The method of claim 1, 2, 3, or 4 wherein the patient is in remission. 11. The method of claim 1, 2, 3, or 4 wherein the patient has received surgical therapy of affected portions of the gastrointestinal tract. 12. The method of claim 1, 2, 3, or 4 wherein the patient has an extraintestinal manifestation of Crohn's disease and the immune stimulatory amount of Sargramostim is sufficient to reduce the extraintestinal manifestation. 13. The method of claim 12 wherein the extraintestinal manifestation is an inflammatory eye disorder. 14. The method of claim 13 wherein the inflammatory eye disorder is selected from the group consisting of: iritis, uveitis, and episcleritis. 15. The method of claim 12 wherein the extraintestinal manifestation a skin disorder. 16. The method of claim 15 wherein the skin disorder is selected from the group consisting of: pyoderma gangrenosum and erythema nodosum. 17. The method of claim 12 wherein the extraintestinal manifestation is a liver disorder. 18. The method of claim 17 wherein the liver disorder is primary scierosing cholangitis. 19. The method of claim 12 wherein the extraintestinal manifestation is bile duct disease. 20. The method of claim 12 wherein the extraintestinal manifestation is stomach inflammation. 21. The method of claim 12 wherein the extraintestinal manifestation is an esophageal disease.

Details for Patent 7,407,931

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	03/05/1991		2020-02-11
Partner Therapeutics, Inc.	LEUKINE	sargramostim	Injection	103362	03/05/1991		2020-02-11