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Last Updated: January 10, 2025

Claims for Patent: 12,133,844

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Summary for Patent: 12,133,844

Title:	Methods of treating epithelioid cell tumors
Abstract:	The present invention provides methods and compositions for treating epithelioid cell tumors (such as a PEComa) by administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin.
Inventor(s):	Neil P. Desai
Assignee:	Abraxis Bioscience LLC
Application Number:	US17/165,652
Patent Claims:	1. A method of treating a malignant perivascular epithelioid tumor (PEComa) in an individual, comprising intravenously administering to the individual an effective amount of a composition comprising nanoparticles comprising sirolimus and an albumin, wherein the effective amount of sirolimus in the nanoparticle composition is about 10 mg/m2 to about 100 mg/m2, and wherein the nanoparticle composition is administered on days 1 and 8 of a 21-day cycle. 2. The method of claim 1, wherein the malignant PEComa is a pulmonary clear cell ‘sugar’ tumor or a PEComa not otherwise specified (PEComa-NOS). 3. The method of claim 1, wherein the malignant PEComa is advanced malignant, locally advanced, metastatic, or recurrent. 4. The method of claim 1, wherein the individual has been previously treated with an mTOR inhibitor. 5. The method of claim 1, wherein the effective amount of sirolimus in the nanoparticle composition is less than about 50 mg/m2. 6. The method of claim 1, wherein the effective amount of sirolimus in the nanoparticle composition is about 10 mg/m2 to about 25 mg/m2. 7. The method of claim 1, wherein the effective amount of sirolimus in the nanoparticle composition is about 25 mg/m2 to about 50 mg/m2. 8. The method of claim 1, wherein the effective amount of sirolimus in the nanoparticle composition is about 10 mg/m2 to about 56 mg/m2. 9. The method of claim 1, wherein the effective amount of sirolimus in the nanoparticle composition is about 45 mg/m2, about 30 mg/m2, or about 10 mg/m2. 10. The method of claim 1, wherein the method is in a neoadjuvant setting. 11. The method of claim 1, wherein the nanoparticles in the composition have an average diameter of no greater than about 150 nm. 12. The method of claim 1, wherein the albumin is human albumin. 13. The method of claim 1, wherein the albumin is human serum albumin. 14. The method of claim 1, wherein the individual is human.

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