Claims for Patent: 7,943,332

Summary for Patent: 7,943,332

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:	12/761,903
Patent Claims:	1. A method of monitoring a hyperproliferative disease comprising measuring a therapeutic antibody:antigen complex in a patient sample, wherein the therapeutic antibody is anti-CD33, and correlating the measured therapeutic antibody:antigen complex to a hyperproliferative disease. 2. The method of claim 1, wherein the hyperproliferative disease is further defined as cancer. 3. The method of claim 2, wherein the cancer comprises a neoplasm. 4. The method of claim 3, wherein the neoplasm 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. 5. The method of claim 3, wherein the neoplasm is a hematopoietic neoplasm selected from the group consisting of chronic lymphocytic leukemia, acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, juvenile myelomonocyte leukemia, multiple myeloma, lymphoma, T-cell chronic lymphocytic leukemia and prolymphocytic leukemia. 6. The method of claim 1, wherein the therapeutic antibody is Mylotarg. 7. A method of staging a myeloid hyperproliferative disease comprising determining the level of soluble CD33 in a patient sample by a sandwich ELISA. 8. The method of claim 7, wherein the myeloid hyperproliferative disease is chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myelogenous leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, juvenile myelomonocyte leukemia, multiple myeloma, hairy cell leukemia, prolymphocytic leukemia, or lymphoma. 9. The method of claim 8, wherein the myeloid hyperproliferative disease is acute myelogenous leukemia. 10. A method of monitoring myeloid hyperproliferative disease comprising measuring the level of soluble CD33, soluble anti-CD33 or CD33/anti-CD33 complexes in a patient sample, and correlating said measured levels to a myeloid hyperproliferative disease. 11. The method of claim 10, wherein the myeloid hyperproliferative disease is chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myelogenous leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, juvenile myelomonocyte leukemia, multiple myeloma, hairy cell leukemia, prolymphocytic leukemia, or lymphoma. 12. The method of claim 11, wherein the hyperproliferative disease is acute myelogenous leukemia. 13. The method of claim 10, wherein the level is measured using a sandwich ELISA. 14. The method of claim 10, further defined as comprising the steps of: (a) measuring the level of circulating cell-free CD33 in a patient sample through the use of an immunoassay, wherein the sample comprises circulating cell-free antigens; and wherein the patient is undergoing treatment for a hematopoietic hyperproliferative disease; and (b) comparing the level of circulating cell-free CD33 to a normal control level of circulating cell-free CD33 to monitor the hyperproliferative disease, wherein a higher level of circulating cell-free CD33 relative to a normal control level is indicative of aggressiveness or more advanced stage of disease.

Details for Patent 7,943,332

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Wyeth Pharmaceuticals Llc	MYLOTARG	gemtuzumab ozogamicin	For Injection	761060	09/01/2017		2021-09-20