Claims for Patent: 10,420,839

Summary for Patent: 10,420,839

Title:	Methods for treating CD52-expressing cancers using compositions comprising nanoparticle complexes of paclitaxel, alemtuzumab, and albumin
Abstract:	Described are stable nanoparticle complexes comprising paclitaxel, albumin and alemtuzumab. The nanoparticle complexes are suitable for the treatment of cancer.
Inventor(s):	Markovic; Svetomir N. (Rochester, MN), Nevala; Wendy K. (Rochester, MN)
Assignee:	Mayo Foundation for Medical Education and Research (Rochester, MN)
Application Number:	15/414,536
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, an antibody with binding specificity for CD52, and paclitaxel, wherein the antibody is alemtuzumab, 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 CD52 binding specificity and the average diameter of greater than 60% of said complexes is between 0.1 .mu.m and 0.95 .mu.m, wherein the cancer expresses CD52. 2. The method of claim 1, wherein the average diameter of greater than 60% 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 greater than 60% 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 leukemia or lymphoma. 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 10,420,839

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2032-10-01
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2032-10-01
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2032-10-01