Claims for Patent: 8,911,786

Summary for Patent: 8,911,786

Title:	Nanoparticle comprising rapamycin and albumin as anticancer agent
Abstract:	The present invention features methods for treating, stabilizing, preventing, and/or delaying cancer by administering nanoparticles that comprise rapamycin or a derivative thereof. The invention also provides compositions (e.g., unit dosage forms) comprising nanoparticles that comprise a carrier protein and rapamycin or a derivative thereof. The invention further provides combination therapy methods of treating cancer comprising administering to an individual an effective amount of nanoparticles that comprise rapamycin or a derivative thereof and a second therapy.
Inventor(s):	Desai; Neil P. (Los Angeles, CA), Soon-Shiong; Patrick (Los Angeles, CA), Trieu; Vuong (Calabasas, CA)
Assignee:	Abraxis Bioscience, LLC (Los Angeles, CA)
Application Number:	12/530,188
Patent Claims:	1. A method of treating cancer in a human individual, comprising administering to an individual an effective amount of a composition comprising nanoparticles that comprise rapamycin or a derivative thereof and albumin, wherein the rapamycin or derivative thereof is coated with albumin, wherein the amount of the rapamycin or derivative thereof in the effective amount of the composition is in the range of about 54 mg to about 180 mg, and wherein the average diameter of the nanoparticle in the capsule is no greater than about 200 nm. 2. The method of claim 1, wherein the cancer is a plasmacytoma. 3. The method of claim 1, wherein the cancer is selected from the group consisting of multiple myeloma, pancreatic cancer, brain cancer, prostate cancer, lung cancer, melanoma, and breast cancer. 4. The method of claim 1, wherein the cancer is bladder cancer, renal cell carcinoma, mesothelioma, or neuroendocrine cancer. 5. The method of claim 4, wherein the cancer is bladder cancer. 6. The method of claim 1, wherein the albumin is human serum albumin. 7. A unit dosage form for treatment of cancer in a human individual comprising (a) nanoparticles that comprise rapamycin or a derivative thereof and albumin, wherein the rapamycin or derivative thereof is coated with albumin, wherein the amount of the rapamycin or derivative thereof in the unit dosage form is in the range of about 54 mg to about 180 mg, and (b) a pharmaceutically acceptable carrier, and wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm. 8. A kit comprising (a) nanoparticles that comprise rapamycin or a derivative thereof and albumin, wherein the rapamycin or derivative thereof is coated with albumin, wherein the amount of the rapamycin or derivative thereof in the kit is in the range of about 54 mg to about 180 mg, and (b) instructions for using the kit in treating cancer in a human individual, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm. 9. A method of treating cancer in a human individual comprising (a) a first therapy comprising administering to an individual an effective amount of a composition comprising nanoparticles that comprise rapamycin or a derivative thereof and albumin, where the rapamycin or derivative thereof is coated with albumin and (b) a second therapy selected from second therapy selected from the group consisting of chemotherapy, radiation therapy, surgery, hormone therapy, gene therapy, bone marrow transplantation, stem cell transplantation, targeted therapy, cryotherapy, ultrasound therapy, and immunotherapy, wherein the amount of the rapamycin or derivative thereof in the effective amount of the composition is in the range of about 54 mg to about 180 mg, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm. 10. The method of claim 9, wherein the second therapy is chemotherapy. 11. The method of claim 10, wherein chemotherapy comprises administration of a chemotherapeutic selected from the group consisting of antimetabolite agents, platinum-based agents, alkylating agents, tyrosine kinase inhibitors, anthracycline antibiotics, vinca alkloids, proteasome inhibitors, and topoisomerase inhibitors. 12. The method of claim 9, wherein the cancer is selected from the group consisting of multiple myeloma, pancreatic cancer, prostate cancer, lung cancer, melanoma, and breast cancer. 13. The method of claim 9, wherein the cancer is bladder cancer, renal cell carcinoma, mesothelioma, or neuroendocrine cancer. 14. The method of claim 9, wherein the first therapy and the second therapy are conducted sequentially. 15. The method of claim 9, wherein the albumin is human serum albumin. 16. The method of claim 10, wherein the chemotherapy comprises administering to the individual an inhibitor of the mTOR signaling pathway. 17. The method of claim 10, wherein the chemotherapy comprises administering to the individual an AKT kinase inhibitor. 18. The method of claim 17, wherein AKT kinase inhibitor is perifosine. 19. The method of claim 10, wherein the chemotherapy comprises administering to the individual a tyrosine kinase inhibitor. 20. The method of claim 19, wherein the tyrosine kinase inhibitor is erlotinib. 21. The method of claim 1, wherein the composition is administered via an intravenous, intraarterial, intraperitoneal, intravesicular, subcutaneous, or intrathecal route. 22. The method of claim 9, wherein the composition is administered via an intravenous, intraarterial, intraperitoneal, intravesicular, subcutaneous, or intrathecal route. 23. The method of claim 1, wherein the composition comprises nanoparticles comprising rapamycin. 24. The method of claim 23, wherein the composition comprises nanoparticles comprising rapamycin and human serum albumin. 25. The method of claim 9, wherein the composition comprises nanoparticles comprising rapamycin. 26. The method of claim 25, wherein the composition comprises nanoparticles comprising rapamycin and human serum albumin. 27. The method of claim 23, wherein the cancer is bladder cancer, renal cell carcinoma, mesothelioma, or neuroendocrine cancer. 28. The method of claim 27, wherein the cancer is bladder cancer. 29. The method of claim 24, wherein the cancer is bladder cancer, renal cell carcinoma, mesothelioma, or neuroendocrine cancer. 30. The method of claim 29, wherein the cancer is bladder cancer. 31. The method of claim 25, wherein the cancer is bladder cancer, renal cell carcinoma, mesothelioma, or neuroendocrine cancer. 32. The method of claim 31, wherein the cancer is bladder cancer. 33. The method of claim 25, wherein the cancer is bladder cancer, renal cell carcinoma, mesothelioma, or neuroendocrine cancer. 34. The method of claim 33, wherein the cancer is bladder cancer. 35. The method of claim 1, wherein the amount of the rapamycin or derivative thereof in the effective amount of the composition is in the range of about 75 mg to about 100 mg. 36. The method of claim 4, wherein the amount of the rapamycin or derivative thereof in the effective amount of the composition is in the range of about 75 mg to about 100 mg. 37. The method of claim 23, wherein the amount of the rapamycin or derivative thereof in the effective amount of the composition is in the range of about 75 mg to about 100 mg.