Claims for Patent: 10,413,531

Summary for Patent: 10,413,531

Title:	Methods of treating bladder cancer
Abstract:	The present invention provides methods and compositions for treating bladder cancer, including metastatic bladder cancer and non-muscle-invasive bladder cancer, by administering a composition comprising nanoparticles that comprise mTOR inhibitor and optionally an albumin.
Inventor(s):	Desai; Neil P. (Pacific Palisades, CA)
Assignee:	Abraxis BioScience, LLC (Summit, NJ)
Application Number:	15/938,952
Patent Claims:	1. A method of treating bladder cancer in an individual, comprising administering to the individual a) an effective amount of a composition comprising nanoparticles comprising rapamycin and an albumin and b) an effective amount of Bacillus Calmette-Guerin (BCG), wherein the nanoparticle composition is administered intravesicularly. 2. The method of claim 1, wherein the bladder cancer is non-muscle-invasive bladder cancer. 3. The method of claim 1, wherein the bladder cancer is refractory to treatment with BCG, mitomycin C, or interferon. 4. The method of claim 1, wherein the nanoparticle composition is administered at least once weekly. 5. The method of claim 1, wherein the dose of rapamycin in the nanoparticle composition is about 5 mg to about 500 mg. 6. The method of claim 5, wherein the dose of rapamycin in the nanoparticle composition is about 30 mg to about 400 mg. 7. The method of claim 5, wherein the nanoparticle composition is administered at a volume of about 20 ml to about 150 ml. 8. The method of claim 5, wherein the nanoparticle composition is retained in the bladder for about 30 minutes to about 4 hours. 9. The method of claim 1, wherein the BCG is administered intravesicularly. 10. The method of claim 9, wherein the BCG is administered at the dose of about 8 mg to about 100 mg. 11. The method of claim 1, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm. 12. The method of claim 1, wherein the nanoparticles comprise rapamycin coated with albumin. 13. The method of claim 1, wherein the bladder cancer is urothelial carcinoma. 14. The method of claim 1, wherein the bladder cancer is a high grade bladder cancer. 15. The method of claim 1, wherein the individual is human. 16. The method of claim 1, wherein the individual is selected for treatment based on the level of one of more of: p-S6K, pAKT, p-4EBP1, Ki67, p53, p63, Stathmin, Tau, SPARC, p73, c-myc, and cyclin D1. 17. The method of claim 16, further comprising determining the level of one of more of: p-S6K, pAKT, p-4EBP1, Ki67, p53, p63, Stathmin, Tau, SPARC, p73, c-myc, and cyclin D1 prior to treatment. 18. The method of claim 16, further comprising selecting the individual for treatment based on a high level of one or more of: p-S6K, pAKT, p-4EBP1, Ki67, p53, p63, Stathmin, Tau, SPARC, p73, c-myc, and cyclin D1. 19. The method of claim 1, further comprising determining the level of one of more of: p-S6K, pAKT, p-4EBP1, Ki67, p53, p63, Stathmin, Tau, SPARC, p73, c-myc, and cyclin D1 after the treatment.

Details for Patent 10,413,531

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2033-03-14