Methods for treating pulmonary non-tuberculous mycobacterial infections
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-031/7036
A61K-009/00
A61K-009/127
A61K-045/06
A61K-031/133
A61K-031/546
A61K-031/65
A61K-031/7048
A61K-031/7052
A61K-031/407
A61K-031/4375
A61K-031/4409
A61K-031/4709
A61K-031/496
A61K-031/5383
A61P-031/04
출원번호
US-0007075
(2018-06-13)
등록번호
US-10251900
(2019-04-09)
발명자
/ 주소
Eagle, Gina
Gupta, Renu
출원인 / 주소
INSMED INCORPORATED
대리인 / 주소
Cooley LLP
인용정보
피인용 횟수 :
0인용 특허 :
262
초록▼
Provided herein are methods for treating a pulmonary infection in a patient in need thereof, for example, a nontuberculous mycobacterial pulmonary infection for at least one treatment cycle. The method comprises administering to the lungs of the patient a pharmaceutical composition comprising a lipo
Provided herein are methods for treating a pulmonary infection in a patient in need thereof, for example, a nontuberculous mycobacterial pulmonary infection for at least one treatment cycle. The method comprises administering to the lungs of the patient a pharmaceutical composition comprising a liposomal complexed aminoglycoside comprising a lipid component comprising electrically neutral lipids and an aminoglycoside. Administration comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free aminoglycoside and liposomal complexed aminoglycoside, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient. The methods provided herein result in a change from baseline on the semi-quantitative scale for mycobacterial culture for a treated patient, and/or NTM culture conversion to negative during or after the administration period.
대표청구항▼
1. A method for treating a Mycobacterium avium complex (MAC) lung infection in a patient previously unresponsive to MAC therapy, comprising: administering to the patient a macrolide antibiotic and ethambutol; andadministering to the lungs of the patient, a pharmaceutical composition comprising amika
1. A method for treating a Mycobacterium avium complex (MAC) lung infection in a patient previously unresponsive to MAC therapy, comprising: administering to the patient a macrolide antibiotic and ethambutol; andadministering to the lungs of the patient, a pharmaceutical composition comprising amikacin, or a pharmaceutically acceptable salt thereof, encapsulated in a plurality of liposomes, wherein the lipid component of the plurality of liposomes consists of dipalmitoylphosphatidylcholine (DPPC) and cholesterol,wherein administering to the lungs of the patient comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free amikacin, or a pharmaceutically acceptable salt thereof, and liposomal complexed amikacin, or a pharmaceutically acceptable salt thereof, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient once daily in a single dosing session, for an administration period of at least six months,wherein the treating comprises achieving a negative MAC sputum culture in the patient. 2. The method of claim 1, wherein the amikacin or pharmaceutically acceptable salt thereof is amikacin sulfate. 3. The method of claim 1, wherein the plurality of liposomes comprises unilamellar vesicles, multilamellar vesicles, or a mixture thereof. 4. The method of claim 1, wherein the pharmaceutical composition comprises from about 500 mg to about 650 mg amikacin, or pharmaceutically acceptable salt thereof. 5. The method of claim 1, wherein during the single dosing session, the aerosolized pharmaceutical composition is administered in less than about 15 minutes. 6. The method of claim 1, wherein during the single dosing session, the aerosolized pharmaceutical composition is administered in about 10 minutes to about 14 minutes. 7. The method of claim 1, wherein the treating comprises achieving MAC sputum culture conversion in the patient, wherein MAC sputum culture conversion is defined as three consecutive negative MAC sputum cultures. 8. The method of claim 1, wherein the macrolide antibiotic is azithromycin, clarithromycin, erythromycin, carbomycin A, josamycin, kitamycin, midecamycin, oleandomycin, solithromycin, spiramycin, troleandomycin, tylosin, roxithromycin, or a combination thereof. 9. The method of claim 8, wherein the macrolide antibiotic is clarithromycin. 10. The method of claim 8, wherein the macrolide antibiotic is azithromycin. 11. The method of claim 1, comprising administering the patient a rifamycin compound. 12. The method of claim 11, wherein the rifamycin compound is rifampin. 13. The method of claim 11, wherein the rifamycin compound is rifabutin. 14. The method of claim 11, wherein the treating comprises achieving MAC sputum culture conversion in the patient, wherein MAC sputum culture conversion is defined as three consecutive negative MAC sputum cultures. 15. A method for treating a Mycobacterium avium complex (MAC) lung infection in a patient refractory to the American Thoracic Society/Infectious Disease Society of America (ATS/IDSA) guideline-based therapy (GBT) for ≥6 months prior to screening, comprising: administering to the patient a macrolide antibiotic and ethambutol; andadministering to the lungs of the patient, a pharmaceutical composition comprising amikacin, or a pharmaceutically acceptable salt thereof, encapsulated in a plurality of liposomes, wherein the lipid component of the plurality of liposomes consists of dipalmitoylphosphatidylcholine (DPPC) and cholesterol,wherein administering to the lungs of the patient comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free amikacin, or a pharmaceutically acceptable salt thereof, and liposomal complexed amikacin, or a pharmaceutically acceptable salt thereof, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient once daily in a single dosing session, for an administration period of at least six months,wherein the treating comprises achieving a negative MAC sputum culture in the patient. 16. The method of claim 15, wherein the patient is refractory to the GBT at least for 6 months. 17. The method of claim 15, wherein the amikacin or pharmaceutically acceptable salt thereof is amikacin sulfate. 18. The method of claim 15, wherein the plurality of liposomes comprises unilamellar vesicles, multilamellar vesicles, or a mixture thereof. 19. The method of claim 15, wherein the pharmaceutical composition comprises from about 500 mg to about 650 mg amikacin, or pharmaceutically acceptable salt thereof. 20. The method of claim 15, wherein during the single dosing session, the aerosolized pharmaceutical composition is administered in less than about 15 minutes. 21. The method of claim 15, wherein during the single dosing session, the aerosolized pharmaceutical composition is administered in about 10 minutes to about 14 minutes. 22. The method of claim 15, wherein the treating comprises achieving MAC sputum culture conversion in the patient, wherein MAC sputum culture conversion is defined as three consecutive negative MAC sputum cultures. 23. The method of claim 15, wherein the macrolide antibiotic is azithromycin, clarithromycin, erythromycin, carbomycin A, josamycin, kitamycin, midecamycin, oleandomycin, solithromycin, spiramycin, troleandomycin, tylosin, roxithromycin, or a combination thereof. 24. The method of claim 23, wherein the macrolide antibiotic is clarithromycin. 25. The method of claim 23, wherein the macrolide antibiotic is azithromycin. 26. The method of claim 15, comprising administering the patient a rifamycin compound. 27. The method of claim 26, wherein the rifamycin compound is rifampin. 28. The method of claim 26, wherein the rifamycin compound is rifabutin. 29. The method of claim 26, wherein the treating comprises achieving MAC sputum culture conversion in the patient, wherein MAC sputum culture conversion is defined as three consecutive negative MAC sputum cultures.
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이 특허에 인용된 특허 (262)
Gallem, Thomas; Stapleton, Kevin; Knoch, Martin, Actuating device for meters and metering aerosol dispensing device with an actuating device for meters.
Borgschulte, Markus; Achtzehner, Wolfgang; Pfichner, Andreas; Kamm, Norbert, Aerosol generating device and inhalation therapy unit provided with this device.
Janoff Andrew S. (Yardley PA) Bolcsak Lois E. (Lawrenceville NJ) Weiner Alan L. (Lawrenceville NJ) Tremblay Paul A. (Hamilton NJ) Bergamini Michael V. W. (Easton PA), Alpha tocopherol-based vesicles.
Barry ; III Clifton E. (Hamilton MT) Yuan Ying (Missoula MT), Anti-mycobacterial compositions and their use for the treatment of tuberculosis and related diseases.
Hersch Evan M. ; Petersen Eskild A. ; Proffitt Richard T. ; Bracken Kevin R. ; Chiang Su-Ming, Antibiotic formulation and use for bacterial infections.
Hersch Evan M. ; Petersen Eskild A. ; Proffitt Richard T. ; Bracken Kevin R. ; Chiang Su-Ming, Antibiotic formulation and use for bacterial infections.
Hersch Evan M. ; Petersen Eskild A. ; Proffitt Richard T. ; Bracken Kevin R. ; Chiang Su-Ming, Antibiotic formulation and use for drug resistant infections.
Hersch Evan M. ; Petersen Eskild A. ; Proffitt Richard T. ; Bracken Kevin R. ; Chiang Su-Ming, Antibiotic formulation and use for drug resistant infections.
Chancellor,Michael B.; Fraser,Matthew O.; Chuang,Yao Chi; de Groat,William C.; Huang,Leaf; Yoshimura,Naoki, Application of lipid vehicles and use for drug delivery.
Gebeyehu Gulilat (Silver Spring MD) Jessee Joel A. (Mt. Airey MD) Ciccarone Valentina C. (Gaithersburg MD) Hawley-Nelson Pamela (Silver Spring MD) Chytil Anna (Nashville TN), Cationic lipids.
Felgner Philip L. (Rancho Santa Fe CA) Kumar Raj (San Diego CA) Basava Channa (San Diego CA) Border Richard C. (Poway CA) Hwang-Felgner Jiin-Yu (Rancho Santa Fe CA), Cationic lipids for intracellular delivery of biologically active molecules.
Felgner, Philip L.; Kumar, Raj; Basava, Channa; Border, Richard C.; Hwang-Felgner, Jiin-Yu, Cationic lipids for intracellular delivery of biologically active molecules.
Drohan William N. ; MacPhee Martin J. ; Miekka Shirley I. ; Singh Manish S. ; Elson Clive,CAX ; Taylor ; Jr. John R., Chitin hydrogels, methods of their production and use.
Cohen, Jonathan Marc; Shah, Syed M.; Ofslager, Christian Luther; Fawzi, Mahdi, Compositions containing pipercillin and tazobactam useful for injection.
Pardoll Drew ; Azhari Rosa,ILX ; Leong Kam W. ; Golumbek Paul ; Jaffee Elizabeth ; Levitsky Hyam ; Lazenby Audrey, Controlled release of pharmaceutically active substances for immunotherapy.
Loeffler, Joseph P.; Rapp, David; Briones, Victor; Bitdinger, Ralf; Klimowicz, Michael, Convertible fluid feed system with comformable reservoir and methods.
Janoff Andrew S. (Lawrenceville NJ) Alving Carl R. (Washington DC) Fountain Michael W. (Plainsboro NJ) Lenk Robert P. (Lambertville NJ) Ostro Marc J. (North Brunswick NJ) Popescu Mircea C. (Plainsbor, Drug preparations of reduced toxicity.
Janoff Andrew S. (Yardley PA) Popescu Mircea C. (Plainsboro NJ) Alving Carl R. (Bethesda MD) Fountain Michael W. (Farragut TN) Lenk Robert P. (The Woodlands TX) Ostro Marc J. (Princeton NJ) Tremblay , Drug preparations of reduced toxicity.
Bally Marcel B. (Vancouver CAX) Cullis Pieter R. (Vancouver CAX) Hope Michael J. (Vancouver CAX) Madden Thomas D. (Vancouver CAX) Mayer Lawrence D. (Vancouver CAX), Encapsulation of antineoplastic agents in liposomes.
Bally Marcel B.,CAX ; Cullis Pieter R.,CAX ; Hope Michael J.,CAX ; Madden Thomas D.,CAX ; Mayer Lawrence D.,CAX, Encapsulation of antineoplastic agents in liposomes.
Janoff Andrew S. ; Cullis Pieter R.,CAX ; Bally Marcel B.,CAX ; Fountain Michael W. ; Ginsberg Richard S. ; Hope Michael J.,CAX ; Madden Thomas D.,CAX ; Schieren Hugh P. ; Jablonski Regina L., Encapsulation of ionizable agents in liposomes.
Fountain Michael W. (Princeton) Weiss Steven J. (Hightstown) Lenk Robert P. (Lambertville) Popescu Mircea C. (Plainsboro) Ginsberg Richard S. (Monroe Township ; Middlesex County NJ), Enhancement of pharmaceutical activity.
Cullis Pieter R. (Vancouver CAX) Hope Michael J. (Vancouver CAX) Bally Marcel B. (Vancouver CAX), Extrusion technique for producing unilamellar vesicles.
Camu Frederic,BEX ; Brasseur Robert,BEX ; Legros Franz,BEX ; Carlino Sandra,BEX, Freeze dried liposome encapsulated amphiphilic drug compositions and a process for the preparation thereof.
Roberts David D. ; Krutzsch Henry C. ; Guo Nenghua, Heparin and sulfatide binding peptides from the type-I repeats of human thrombospondin and conjugates thereof.
Li, Zhili; Boni, Lawrence T.; Miller, Brian S.; Malinin, Vladimir; Li, Xingong, High delivery rates for lipid based drug formulations, and methods of treatment thereof.
Mayer Lawrence D. (Vancouver CAX) Bally Marcel B. (Vancouver CAX) Cullis Pieter R. (Vancouver CAX) Ginsberg Richard S. (Jamesburg NJ) Mitilenes George N. (Washington NJ), High drug:lipid formulations of liposomal antineoplastic agents.
Minchey Sharma R. (Monmouth Junction NJ) Swenson Christine E. (Princeton Junction NJ) Janoff Andrew S. (Yardley PA) Boni Lawrence (Monmouth Junction NJ) Stewart Kathy A. (Morrison IL) Perkins Walter , High ratio active agent: lipid complex.
Khokhar Abdul R. (Harris TX) Lopez-Berestein Gabriel (Harris TX) Perez-Soler Roman (Harris TX), Hydrophobic cis-platinum complexes efficiently incorporated into liposomes.
Zalipsky Samuel (Fremont CA) Woodle Martin C. (Menlo Park CA) Lasic Danilo D. (Newark CA) Martin Francis J. (San Francisco CA), Lipid-polymer conjugates and liposomes.
Bolotin Elijah M. ; Grant Gilbert J. ; Barenholz Yechezkel,ILX ; Turndorf Herman ; Piskoun Boris, Liposomal bupivacaine compositions prepared using an ammonium sulfate gradient.
Bally Marcel B. (Vancouver NJ CAX) Bolcsak Lois E. (Lawrenceville NJ) Cullis Pieter R. (Vancouver PA CAX) Janoff Andrew S. (Yardley PA) Mayer Lawrence D. (Vancouver CAX), Liposomes comprising aminoglycoside phosphates and methods of production and use.
Axelsson Bengt I. (Genarp SEX) Brattsand Ralph L. (Lund SEX) Dahlbck Carl M. O. (Lund SEX) Kllstrm Leif A. (Sdra Sandby SEX) Trofast Jan W. (Lund SEX), Liposomes containing steroid esters.
Janoff Andrew S. (Yardley PA) Boni Lawrence (Monmouth Junction NJ) Madden Thomas D. (Vancouver CAX) Cullis Pieter R. (Vancouver CAX) Lenk Robert P. (Lambertville NJ) Kearns John J. (Princeton NJ) Dur, Low toxicity drug-lipid systems.
Pumm, Gerhard; Seifert, René; Holzmann, Philipp; Brune, Nicole, Membrane nebulizer and method for welding a membrane to a carrier during the production of a membrane nebulizer.
Radhakrishnan Ramachandran (Fremont CA) Mihalko Paul J. (Fremont CA) Abra Robert M. (San Francisco CA), Method and apparatus for administering dehydrated liposomes by inhalation.
Eppstein Deborah A. (Palo Alto CA) Fraser-Smith Elizabeth (Los Altos CA) Matthews Thomas R. (Los Gatos CA), Method for enhancing the anti-infective activity of muramyldipeptide derivatives.
Janoff Andrew S. (Yardley PA) Cullis Pieter R. (Vancouver CAX) Bally Marcel B. (Vancouver CAX) Fountain Michael W. (Griggstown NJ) Ginsberg Richard S. (Monroe NJ) Hope Michael J. (Vancouver CAX) Madd, Method of dehydrating liposomes using protective sugars.
Papahadjopoulos Demetrios P. (78 Heathwood Williamsville NY 14221) Szoka ; Jr. Francis C. (375 Leroy Ave. Buffalo NY 14214), Method of encapsulating biologically active materials in lipid vesicles.
Szoka ; Jr. Francis C. (76 Summit St. Waltham MA 02154) Papahadjopoulos Demetrios P. (3170 Condit St. Lafayette CA 94549), Method of inserting DNA into living cells.
Coe Royden M. (Bordentown NJ) Edgerly-Pflug Laura (Spotswood NJ) Boni Lawrence (Monmouth Junction NJ) Portnoff Joel (Richboro PA) Minchey Sharma R. (Monmouth Junction NJ), Method of producing liposomes.
Fink, James B.; Power, John; Ivri, Ehud; Smith, Niall; Dunne, Paul; O'Sullivan, Gavan; Moran, Declan; Gibbons, Keith, Methods and systems for operating an aerosol generator.
Grinstaff Mark W. (Pasadena CA) Soon-Shiong Patrick (Los Angeles CA) Wong Michael (Champagne IL) Sandford Paul A. (Los Angeles CA) Suslick Kenneth S. (Champagne IL) Desai Neil P. (Los Angeles CA), Methods for the preparation of immunostimulating agents for in vivo delivery.
Janoff Andrew S. ; Cullis Pieter R.,CAX ; Bally Marcel B.,CAX ; Fountain Michael W. ; Ginsberg Richard S. ; Hope Michael J.,CAX ; Madden Thomas D.,CAX ; Schieren Hugh P. ; Jablonski Regina L., Methods of dehydrating, storing and rehydrating liposomes.
Boni Lawrence T. ; Janoff Andrew S. ; Minchey Sharma R. ; Perkins Walter R. ; Swenson Christine E. ; Ahl Patrick L. ; Davis Thomas S., Methods of preparing interdigitation-fusion liposomes and gels which encapsulate a bioactive agent.
Cullis Pieter R. (Vancouver CAX) Bally Marcel B. (Vancouver CAX) Hope Michael J. (Vancouver PA CAX) Janoff Andrew S. (Yardley PA) Mayer Lawrence D. (Vancouver CAX), Multilamellar liposomes having improved trapping efficiencies.
Kim Sinil ; Howell Stephen B., Multivesicular liposomes having a biologically active substance encapsulated therein in the presence of a hydrochloride.
Legros Franz (rue de Plagniau 8 B-1330 Rixensart BEX) Leroy Claude-Pascal (rue de la Follie 2 B-7190 Ecaussinnes BEX), Pharmaceutical composition containing a hydrophilic active compound, treated with an organic acid and encapsulated in a.
Boni Lawrence T. ; Janoff Andrew S. ; Minchey Sharma R. ; Perkins Walter R. ; Swenson Christine E. ; Ahl Patrick L. ; Davis Thomas S., Pharmaceutical compositions containing interdigitation-fusion liposomes and gels.
David A. Edwards ; Giovanni Caponetti ; Jeffrey S. Hrkach ; Noah Lotan IL; Justin Hanes ; Robert S. Langer ; Abdellaziz Ben-Jebria, Porous particles for deep lung delivery.
Loughrey Helen C. (Vancouver CAX) Cullis Pieter R. (Vancouver CAX) Bally Marcel B. (Bowen Island CAX) Choi Lewis S. L. (Burnaby CAX) Wong Kim F. (Vancouver CAX), Preparation of targeted liposome systems of a defined size distribution.
Benson Bradley J. (170 Cresta Vista Dr. San Francisco CA 94127) Wright JoRae (170 Cresta Vista Dr. San Francisco CA 94127), Pulmonary administration of pharmaceutically active substances.
Knight Jack V. (Houston TX) Gilbert Brian E. (Houston TX) Wilson Samuel Z. (Houston TX) Six Howard R. (East Stroudsborg PA) Wyde Philip R. (Houston TX), Small particle aerosol liposome and liposome-drug combinations for medical use.
Frank Sylvan G. (Columbus OH) Brodin Arne F. (Sodertalje NY SEX) Chen Chih-Ming J. (East Syracuse NY) Shrivastava Ratnesh (Columbus OH), Small particle formation.
Lenk Robert P. (Lambertville NJ) Fountain Michael W. (Griggstown NJ) Janoff Andrew S. (Yardley PA) Popescu Mircea C. (Plainsboro NJ) Weiss Steven J. (Hightstown NJ) Ginsberg Richard S. (Monroe Townsh, Stable plurilamellar vesicles.
Lenk Robert P. (Lambertville NJ) Fountain Michael W. (Griggstown NJ) Janoff Andrew S. (Yardley PA) Popescu Mircea C. (Plainsboro NJ) Weiss Steven J. (Hightstown NJ) Ginsberg Richard S. (Monroe Townsh, Stable plurilamellar vesicles.
Lenk Robert P. (Lambertville NJ) Fountain Michael W. (Plainsboro NJ) Janoff Andrew S. (Lawrenceville NJ) Ostro Marc J. (North Brunswick NJ) Popescu Micrea C. (Plainsboro NJ), Stable plurilamellar vesicles, their preparation and use.
Janoff Andrew S. (Yardley PA) Popescu Mircea C. (Plainsboro NJ) Weiner Alan L. (Plainsboro NJ) Bolcsak Lois E. (Lawrenceville NJ) Tremblay Paul S. (Hamilton NJ), Steroidal liposomes.
Unger Evan C. (Tucson AZ) Fritz Thomas A. (Tucson AZ) Matsunaga Terry (Tucson AZ) Ramaswami VaradaRajan (Tucson AZ) Yellowhair David (Tucson AZ) Wu Guanli (Tucson AZ), Therapeutic drug delivery systems.
Popescu Mircea (Plainsboro NJ) Swenson Christine E. (Plainsboro NJ) Johnson Sterling C. (Skillman NJ) Lenk Robert P. (Lambertville NJ), Therapeutic treatment by intramammary infusion.
Haartsen, Jaap Roger; Dekker, Ronald; De Graaf, Pascal; Van Veen, Nicolaas Johannes Anthonius; Schipper, Alphonsus Tarcisius Jozef Maria, Thermal flow sensor integrated circuit with low response time and high sensitivity.
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