Claims for Patent: 10,478,495

Summary for Patent: 10,478,495

Title:	Methods for treating cancer using nanoparticle complexes of paclitaxel, cetuximab, and albumin
Abstract:	The invention relates to methods for treating cancer (e.g., EGFR-expressing cancer) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and antibody-albumin nanoparticle complexes, said complexes comprising albumin, a cetuximab antibody and paclitaxel.
Inventor(s):	Markovic; Svetomir N. (Rochester, MN), Nevala; Wendy K. (Rochester, MN)
Assignee:	Mayo Foundation for Medical Education and Research (Rochester, MN)
Application Number:	15/412,581
Patent Claims:	1. A method for treating cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and antibody-albumin nanoparticle complexes, said complexes comprising albumin, a cetuximab antibody, and paclitaxel, wherein the nanoparticle complexes have been, pre-formed in vitro by mixing aqueous albumin-paclitaxel nanoparticles with the antibody under conditions to form the nanoparticle complexes, such that the nanoparticle complexes have EGFR binding specificity, wherein the cancer expresses EGFR, and wherein the average diameter of said complexes is between 0.1 .mu.m and 1 .mu.m. 2. The method of claim 1, wherein the average diameter of said complexes is between 0.1 .mu.m and 0.9 .mu.m. 3. The method of claim 1, wherein the average diameter of said complexes is between 0.1 .mu.m and 0.3 .mu.m. 4. The method of claim 1, wherein the ratio of albumin-paclitaxel nanoparticle to antibody is between 5:1 and 1:2.5. 5. The method of claim 1, wherein the pharmaceutical composition is administered by intravenous injection. 6. The method of claim 1, wherein the subject is a human. 7. The method of claim 1, wherein the cancer is head and neck cancer, lung cancer, or colon cancer. 8. The method of claim 1, wherein the therapeutically effective amount is between about 30 mg/m.sup.2 and about 70 mg/m.sup.2 antibody. 9. The method of claim 1, wherein the therapeutically effective amount is between about 5 mg/kg and about 20 mg/kg antibody. 10. The method of claim 1, wherein the therapeutically effective amount is between about 50 mg/m.sup.2 and about 175 mg/m.sup.2 albumin-paclitaxel nanoparticles. 11. The method of claim 1, wherein the pharmaceutical composition is administered from about once a month to about three times a month. 12. The method, of claim 1, wherein the pharmaceutical composition is administered three times per 28 day cycle for at least two cycles. 13. The method of claim 1, wherein said composition comprises an alkylating agent. 14. The method of claim 13, wherein said alkylating agent is a platinum compound. 15. The method of claim 1, wherein the pharmaceutically acceptable carrier is saline, water, lactic acid, mannitol, or a combination thereof.

Details for Patent 10,478,495

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2032-10-01
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2032-10-01