Methods for diagnosis using anti-cytokine receptor antibodies

• US 7,727,528 B2
• Filed: 07/20/2005
• Issued: 06/01/2010
• Est. Priority Date: 07/22/2004
• Status: Active Grant

• Current Assignee: Early Detection, Inc.
• Original Assignee: Early Detection, Inc.
• Inventors: Adcock, Deborah Kay
• Primary Examiner(s): DENT, ALANA HARRIS
• Application Number:
  US11/185,335
• Publication Number:
  US 20060039857A1
• Time in Patent Office: 1,777 Days
• Field of Search: 424/130.1, 424/133.1, 424/138.1, 424/143.1, 436/57, 436/64, 436/164, 514/1, 514/2
• US Class Current: 424/143.1
• CPC Class Codes: A61K 51/08 Peptides, e.g. proteins , carriers being peptides, polyamino acids, proteins
• CPC Class Codes: A61K 51/1021 against cytokines, e.g. growth factors, VEGF, TNF, lymphokines or interferons
• CPC Class Codes: A61K 51/1033 against receptors for cytokines, lymphokines or interferons

Abstract

Labeled antibodies, antibody fragments or peptides binding to soluble cytokines or cytokine receptors are used to diagnose whether a patient has cancer or an autoimmune disease. In a preferred embodiment, a radiolabelled tag that is chemically bound to a peptide, antibody, or antibody fragment specific for sTNFR-1 and/or sTNFR2 is injected into a patient with a tumor, or suspected tumor, or with any disease associated with STNF-1/STNF-2. The patient is then imaged using standard nuclear imaging equipment to detect areas or sites of concentration of the radiolabel and/or receptor/inhibitor and/or antigen. By screening for cancer by the substances it produces, using an injected antibody to that substance with a tracer attached to it, one can detect cancer at a very early stage, potentially even microscopically.

Claims

1. A method for diagnosing inflammation or cancer comprising administering to a patient, effective amount of antibody or antibody fragments binding to soluble tumor necrosis factor receptor 1 (“

TNFR1”

) or tumor necrosis factor 2 (“

TNFR2”

), to bind the circulating soluble receptor, then

administering an effective amount of a labeled antibody binding to the tumor necrosis factor receptor to bind the tumor necrosis factor receptor on the surface of tumor cells and in the tumor microenvironment, and

imaging the patient to detect labeled antibody bound to the tumor necrosis factor receptor on the surface of the tumor cells and in the tumor microenvironment.

2. The method of claim 1 wherein the antibodies are humanized monoclonal antibodies.

3. The method of claim 1 wherein the antibodies are labeled with a label selected from the group consisting of I¹²⁵, I¹²³ and I¹³¹.

4. The method of claim 1 wherein the patient has cancer.

5. The method of claim 1 wherein the patient has an autoimmune disease.

6. The method of claim 1 wherein the patient has a chronic or acute infectious disease.

7. The method of claim 1 wherein 5 mg of radiolabeled antibody is intravenously administered on day zero, then a second infusion of 5 mg of labeled antibody is administered, and whole-body images recorded one hour, 2 days, and 4 days after the second infusion.

8. The method of claim 1 wherein the patient is imaged one, two or four days after administration of labeled antibody.

9. The method of claim 1 wherein the labeled antibody is detected using PET.

10. The method of claim 1 wherein the labeled antibody is detected using MRI.

11. The method of claim 1 wherein the antibodies further include antibodies selected from the group consisting of soluble interleukin-1receptor (“

sIL-1R”

), soluble interleukin-6 receptor (“

sIL-6R”

), soluble interferon-gamma receptor (“

sIFN-gammaR”

), and soluble interleukin-12 receptor (sIL-12R).