Claims for Patent: 5,824,643

Summary for Patent: 5,824,643

Title:	Therapeutic uses of keratinocyte growth factor
Abstract:	Based on extensive in vivo studies in animals, it has now been discovered that KGF stimulates proliferation, growth and differentiation in various cells of epithelial tissue, besides keratinocytes. This better understanding of the biological effects of KGF in vivo enables the use of this polypeptide as a therapeutic agent, suitably formulated in a pharmaceutical composition, for the specific treatment of disease states and medical conditions afflicting tissues and organs such as the dermal adnexae, the liver, the lung, and the gastrointestinal tract.
Inventor(s):	Pierce; Glenn Francis (Rancho Santa Fe, CA), Housley; Regina Mae (Thousand Oaks, CA), Morris; Charles Frederick (Newbury Park, CA)
Assignee:	Amgen Inc. (Thousand Oaks, CA)
Application Number:	08/482,251
Patent Claims:	1. A method of treating a condition in a patient, said method comprising administering to such patient an effective amount of a keratinocyte growth factor product to stimulate the proliferation or differentiation of epithelial cells selected from the group consisting of hepatocytes, type II pneumocytes, mucin-producing goblet cells, and other epithelial cells and their progenitors contained within the liver, lung, and gastrointestinal tract. 2. The method of claim 1, wherein the keratinocyte growth factor product is formulated in a pharmaceutical composition. 3. The method of claim 2, wherein the pharmaceutical composition comprises an aqueous or a non-aqueous carrier. 4. The method of claim 3, wherein the non-aqueous carrier is selected from the group consisting of collagen and hyaluronic acid. 5. The method of claim 1, wherein the patient is administered a prophylactically or therapeutically effective amount of the keratinocyte growth factor product. 6. The method of claim 1, wherein the keratinocyte growth factor product is a naturally occurring keratinocyte growth factor, is a chemically synthesized keratinocyte growth factor, or is a recombinantly produced keratinocyte growth factor. 7. The method of claim 6, wherein the recombinantly produced keratinocyte growth factor comprises the amino acid sequence of a naturally occurring keratinocyte growth factor. 8. The method of claim 7, wherein the recombinantly produced keratinocyte growth factor is produced in bacterial cells. 9. The method of claim 8, wherein the bacterial cells are E. coli. 10. The method of claim 7, wherein the recombinant keratinocyte growth factor is administered by injection, orally, topically, intranasally or by pulmonary delivery. 11. The method of claim 10, wherein the recombinant keratinocyte growth factor is administered by injection. 12. The method of claim 10, wherein the recombinant keratinocyte growth factor is administered by pulmonary delivery. 13. The method of claim 7, wherein the recombinant keratinocyte growth factor is formulated in a pharmaceutical composition. 14. The method of claim 13, wherein the pharmaceutical composition comprises an aqueous or a non-aqueous carrier. 15. The method of claim 14, wherein the non-aqueous carrier is selected from the group consisting of collagen and hyaluronic acid. 16. A method for the treatment, including for the therapy or prevention, of a gastric ulcer, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof. 17. A method for the treatment, including for the therapy or prevention, of a duodenal ulcer, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof. 18. A method for the treatment, including for the therapy or prevention, of erosions of the stomach and esophagus, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof. 19. The method of claim 18, in which the illness being treated is erosive gastritis, esophagitis, or esophageal reflux. 20. A method for the treatment including for the therapy or prevention, of inflammatory bowel diseases, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof. 21. A method for the treatment, including for the therapy or preventions of radiation or chemotherapy-induced gut toxicity, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof. 22. A method for the treatment, including for the therapy or prevention, of necrosis of the respiratory epithelium caused by smoke inhalation, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof. 23. A method for the treatment, including for the therapy or prevention, of emphysema, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof. 24. A method for the treatment, including for the therapy or prevention, of pulmonary inflammation and fibrosis, comprising administering an effective amount of a keratinocyte growth factor product to a patient in need thereof.

Details for Patent 5,824,643

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	December 15, 2004		2015-10-20

International Patent Family for US Patent 5,824,643

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9423032
United States of America	5965530
United States of America	5814605