Claims for Patent: 8,232,068

Summary for Patent: 8,232,068

Title:	Measuring circulating therapeutic antibody, antigen and antigen/antibody complexes using ELISA assays
Abstract:	The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.
Inventor(s):	Albitar; Maher (Sugarland, TX), Keating; Michael J. (Houston, TX), Manshouri; Taghi (Houston, TX)
Assignee:	Board of Regents, The University of Texas System (Austin, TX)
Application Number:	13/349,170
Patent Claims:	1. A method of determining tumor mass comprising: contacting a patient sample with a first anti-CD20 antibody, wherein the first anti-CD20 antibody captures circulating cell-free CD20 in the patient sample; contacting the captured circulating cell-free CD20 with a second anti-CD20 antibody; and measuring the level of the second anti-CD20 antibody, wherein the level of the second anti-CD20 antibody correlates with tumor mass. 2. The method of claim 1, wherein the patient sample is selected from the group consisting of serum, cell lysate and plasma. 3. The method of claim 1 wherein the first antibody or the second anti-CD20 antibody is Rituximab. 4. The method of claim 1 wherein the second anti-CD20 antibody is labeled. 5. The method of claim 4, wherein the labeled second anti-CD20 antibody is Rituximab. 6. The method of claim 1, wherein the tumor is melanoma, non-small cell lung, small-cell lung, lung hepatocarcinoma, retinoblastoma, astrocytoma, gliobastoma, gum, tongue, leukemia, neuroblastoma, head, neck, breast, pancreatic, prostate, renal, bone, testicular, ovarian, mesothelioma, cervical, gastrointestinal, lymphoma, brain, colon, or bladder. 7. The method of claim 1, wherein the tumor is a B-cell tumor. 8. The method of claim 7, wherein the B-cell tumor is chronic lymphocytic leukemia. 9. A method of measuring circulating cell-free CD20 comprising: contacting a sample with a first anti-CD20 antibody, wherein the first anti-CD20 antibody captures circulating cell-free CD20 in the sample; contacting the captured circulating cell-free CD20 with a second anti-CD20 antibody; and measuring the level of the second anti-CD20 antibody, wherein the level of the second anti-CD20 antibody correlates with the level of circulating cell-free CD20. 10. The method of claim 9, wherein the sample is selected from the group consisting of serum, cell lysate and plasma. 11. The method of claim 9 wherein the first antibody or the second anti-CD20 antibody is Rituximab. 12. The method of claim 9 wherein the second anti-CD20 antibody is labeled. 13. The method of claim 12, wherein the labeled second anti-CD20 antibody is Rituximab.

Details for Patent 8,232,068

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2021-09-20
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2021-09-20
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2021-09-20