Claims for Patent: 9,402,603

Summary for Patent: 9,402,603

Title:	Use of pulmonary surfactants in lung transplantation and methods thereof
Abstract:	The present invention concerns a method of treating an advanced lung disease in a patient in need thereof by lung transplantation.
Inventor(s):	Bianco; Federico (Parma, IT), Razzetti; Roberta (Parma, IT), Vitulo; Patrizio (Parma, IT), Bertani; Alessandro (Parma, IT)
Assignee:	CHIESI FARMACEUTICI S.p.A. (Parma, IT)
Application Number:	13/736,132
Patent Claims:	1. A method of treating an advanced lung disease selected from the group consisting of advanced chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and idiopathic pulmonary arterial hypertension (IPAH) in a patient in need thereof by lung transplantation, said method comprising: (i) withdrawing a lung with trachea to be implanted from a donor and dissecting it on a backtable; (ii) administering a therapeutically effective amount of an aqueous suspension of pulmonary surfactant poractant alfa having a concentration of 80 mg/ml based on the total volume of said aqueous suspension directly into the trachea on said back table after withdrawal of said lung; (iii) preserving said lung until implantation; and (iv) transplanting said lung into said patient, wherein said preserving said lung (iii) is carried out by applying a hypothermic (cold) static lung preservation technique. 2. A method according to claim 1, wherein said cold preservation technique is performed at a temperature of 4.degree. C. 3. A method according to claim 1, wherein said poractant alfa is administered in an amount of 10 to 200 mg/kg of body weight of said donor. 4. A method according to claim 1, wherein said poractant alfa is administered in an amount of 25 to 80 mg/kg of body weight of said donor. 5. A method according to claim 1, wherein said poractant alfa is administered in an amount of 30 mg/kg of body weight of said donor. 6. A method according to claim 1, wherein said poractant alfa is administered into the trachea with a bronchoscope. 7. A method according to claim 1, wherein said poractant alfa is administered into the trachea without a bronchoscope. 8. A method according to claim 1, wherein said advanced lung disease is advanced chronic obstructive pulmonary disease (COPD). 9. A method according to claim 1, wherein said advanced lung disease is idiopathic pulmonary fibrosis (IPF). 10. A method according to claim 1, wherein said advanced lung disease is cystic fibrosis (CF). 11. A method according to claim 1, wherein said advanced lung disease is emphysema due to alpha-1 antitrypsin deficiency. 12. A method according to claim 1, wherein said advanced lung disease is idiopathic pulmonary arterial hypertension (IPAH). 13. A method according to claim 1, wherein said cold preservation technique is performed at a temperature of 4.degree. C. or 10.degree. C. 14. A method of treating an advanced lung disease selected from the group consisting of advanced chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and idiopathic pulmonary arterial hypertension (IPAH) in a patient in need thereof by lung transplantation, said method comprising: (i) withdrawing a lung with trachea to be implanted from a donor and dissecting it on a backtable; (ii) administering a therapeutically effective amount of an aqueous suspension of pulmonary surfactant poractant alfa having a concentration of 80 mg/ml based on the total volume of said aqueous suspension directly into the trachea on said back table after withdrawal of said lung; (iii) preserving said lung until implantation; and (iv) transplanting said lung into said patient, wherein said preserving said lung (iii) is carried out by applying a hypothermic (cold) static lung preservation technique without continuous perfusion and ventilation. 15. A method according to claim 14, wherein said cold preservation technique is performed at a temperature of 4.degree. C. 16. A method according to claim 14, wherein said poractant alfa is administered in an amount of 10 to 200 mg/kg of body weight of said donor. 17. A method according to claim 14, wherein said poractant alfa is administered in an amount of 25 to 80 mg/kg of body weight of said donor. 18. A method according to claim 14, wherein said poractant alfa is administered in an amount of 30 mg/kg of body weight of said donor. 19. A method according to claim 14, wherein said poractant alfa is administered into the trachea with a bronchoscope. 20. A method according to claim 14, wherein said poractant alfa is administered into the trachea without a bronchoscope. 21. A method according to claim 14, wherein said advanced lung disease is advanced chronic obstructive pulmonary disease (COPD). 22. A method according to claim 14, wherein said advanced lung disease is idiopathic pulmonary fibrosis (IPF). 23. A method according to claim 14, wherein said advanced lung disease is cystic fibrosis (CF). 24. A method according to claim 14, wherein said advanced lung disease is emphysema due to alpha-1 antitrypsin deficiency. 25. A method according to claim 14, wherein said advanced lung disease is idiopathic pulmonary arterial hypertension (IPAH). 26. A method according to claim 14, wherein said cold preservation technique is performed at a temperature of 4.degree. C. or 10.degree. C.

Details for Patent 9,402,603

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Chiesi Usa, Inc.	CUROSURF	poractant alfa	Suspension	020744	11/18/1999		2032-11-06