Claims for Patent: 9,101,543

Summary for Patent: 9,101,543

Title:	Combinations and modes of administration of therapeutic agents and combination therapy
Abstract:	The present invention provides combination therapy methods of treating proliferative diseases (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include, for example, radiation, surgery, administration of chemotherapeutic agents, or combinations thereof. Also provided are methods of administering to an individual a drug taxane in a nanoparticle composition based on a metronomic dosing regime.
Inventor(s):	Desai; Neil P. (Los Angeles, CA), Soon-Shiong; Patrick (Los Angeles, CA)
Assignee:	ABRAXIS BIOSCIENCE, LLC (Los Angeles, CA)
Application Number:	13/585,696
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,101,543
Patent Claims:	1. A method of treating pancreatic cancer in a human individual in need thereof, comprising intravenously administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising paclitaxel coated with albumin, wherein the average diameter of the nanoparticles in the composition is no greater than 200 nm, and b) an effective amount of gemcitabine. 2. The method of claim 1, wherein the nanoparticle composition and the gemcitabine are administered sequentially to the individual. 3. The method of claim 2, wherein the nanoparticle composition is administered before the administration of gemcitabine. 4. The method of claim 1, wherein the nanoparticle composition and the gemcitabine are both administered weekly to the individual. 5. The method of claim 1, wherein the nanoparticle composition and the gemcitabine are administered three out of four weeks to the individual. 6. The method of claim 1, wherein the method comprises administering about 30 to about 300 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 7. The method of claim 6, wherein the method comprises administering about 50 to about 250 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 8. The method of claim 7, wherein the method comprises administering about 100 to about 150 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 9. The method of claim 8, wherein the method comprises administering about 125 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 10. The method of claim 8, wherein the method comprises administering about 1000 to about 2000 mg/m.sup.2 gemcitabine to the individual. 11. The method of claim 1, wherein the albumin is human serum albumin. 12. The method of claim 11, wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 1:1 to about 18:1. 13. The method of claim 12, wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 2:1 to about 15:1. 14. The method of claim 13, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 4:1 to about 10:1. 15. The method of claim 14, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 9:1. 16. The method of claim 1, wherein the nanoparticles composition is sterile filterable. 17. The method of claim 1, wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 1:1 to about 18:1. 18. The method of claim 17, wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 2:1 to about 15:1. 19. The method of claim 18, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 4:1 to about 10:1. 20. The method of claim 19, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 9:1. 21. The method of claim 1, wherein the pancreatic cancer is metastatic pancreatic cancer. 22. The method of claim 21, wherein the nanoparticle composition and the gemcitabine are administered sequentially to the individual. 23. The method of claim 22, wherein the nanoparticle composition is administered before the administration of gemcitabine. 24. The method of claim 23, wherein the method comprises administering about 30 to about 300 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 25. The method of claim 24, wherein the method comprises administering about 50 to about 250 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 26. The method of claim 25, wherein the method comprises administering about 100 to about 150 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 27. The method of claim 26, wherein the method comprises administering about 125 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 28. The method of claim 27, wherein the method comprises administering about 1000 to about 2000 mg/m.sup.2 gemcitabine to the individual. 29. The method of claim 28, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 4:1 to about 10:1. 30. The method of claim 29, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 9:1. 31. The method of claim 23, wherein the nanoparticle composition and the gemcitabine are administered three out of four weeks to the individual. 32. The method of claim 21, wherein the method comprises administering about 30 to about 300 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 33. The method of claim 32, wherein the method comprises administering about 50 to about 250 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 34. The method of claim 33, wherein the method comprises administering about 100 to about 150 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 35. The method of claim 34, wherein the method comprises administering about 125 mg/m.sup.2 paclitaxel in a nanoparticle composition to the individual. 36. The method of claim 35, wherein the method comprises administering about 1000 to about 2000 mg/m.sup.2 gemcitabine to the individual. 37. The method of claim 36, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 4:1 to about 10:1. 38. The method of claim 37, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 9:1. 39. The method of claim 21, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 4:1 to about 10:1. 40. The method of claim 39, wherein the weight ratio of the albumin and the paclitaxel in the paclitaxel composition is about 9:1. 41. The method of claim 1, wherein the pancreatic cancer is advanced pancreatic cancer.