USE OF 2 ANTI-SPARC ANTIBODIES TO PREDICT RESPONSE TO CHEMOTHERAPY

• US 20130172261A1
• Filed: 02/25/2013
• Published: 07/04/2013
• Est. Priority Date: 05/28/2009
• Status: Active Grant

• Current Assignee: Abraxis Bioscience LLC (Bristol-Myers Squibb Company)
• Original Assignee: Abraxis Bioscience LLC (Bristol-Myers Squibb Company)
• Inventors: Trieu, Vuong, Desai, Neil, Knauer, Daniel
• Granted Patent: US 9,091,697 B2
• Time in Patent Office: Days
• US Class Current: 514/15.2
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/38 Albumins
• CPC Class Codes: A61K 47/643 Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
• CPC Class Codes: A61K 47/6929 the form being a nanoparticle, e.g. an immuno-nanoparticle
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/57484 involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

The invention provides anti-SPARC antibody-based techniques for predicting a response to chemotherapy.

Claims

1. A method for predicting the response of a tumor in an animal to a chemotherapeutic regimen comprising:

(a) applying a first anti-SPARC antibody to a histologic section of the tumor, wherein the first anti-SPARC antibody preferentially immunostains SPARC in tumor cells;

(b) applying a second anti-SPARC antibody to the histologic section of (a) or a second histologic section of the tumor, wherein the second anti-SPARC antibody preferentially immunostains SPARC in fibroblasts; and

(c) predicting a positive response to the chemotherapeutic regimen if the first anti-SPARC antibody and the second anti-SPARC antibody immunostain the histologic section or sections.

3. The method of claim 1, wherein the first anti-SPARC antibody recognizes a SPARC epitope recognized by monoclonal antibody MAB941, and wherein the second antibody recognizes an immunodominant SPARC epitope recognized by polyclonal antibody AF941.

4. The method of claim 1, wherein the first anti-SPARC antibody is MAB941, and wherein the second antibody is AF941.

14. The method of claim 1, wherein the tumor is selected from the group consisting of oral cavity tumors, pharyngeal tumors, digestive system tumors, the respiratory system tumors, bone tumors, cartilaginous tumors, bone metastases, sarcomas, skin tumors, melanoma, breast tumors, the genital system tumors, urinary tract tumors, orbital tumors, brain and central nervous system tumors, gliomas, endocrine system tumors, thyroid tumors, esophageal tumors, gastric tumors, small intestinal tumors, colonic tumors, rectal tumors, anal tumors, liver tumors, gall bladder tumors, pancreatic tumors, laryngeal tumors, tumors of the lung, bronchial tumors, non-small cell lung carcinoma, small cell lung carcinoma, uterine cervical tumors, uterine corpus tumors, ovarian tumors, vulvar tumors, vaginal tumors, prostate tumors, prostatic carcinoma, testicular tumors, tumors of the penis, urinary bladder tumors, tumors of the kidney, tumors of the renal pelvis, tumors of the ureter, head and neck tumors, parathyroid cancer, Hodgkin'"'"'s disease, Non-Hodgkin'"'"'s lymphoma, multiple myeloma, leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, chronic myeloid leukemia and anal tumors.

15. The method of claim 1, wherein chemotherapeutic regimen comprises administering of one or more of mechlorethamine, cyclophosphamide, ifosfamide, melphalan (L-sarcolysin), chlorambucil, ethylenimines, methylmelamines, hexamethylmelamine, thiotepa, busulfan, carmustine (BCNU), semustine (methyl-CCNU), lomustine (CCNU), streptozocin (streptozotocin), estramustine phosphate, dacarbazine (DTIC, dimethyl-triazenoimidazolecarboxamide), temozolomide, methotrexate (amethopterin), fluorouracin (5-fluorouracil, 5-FU, 5FU), floxuridine (fluorodeoxyuridine, FUdR), cytarabine (cytosine arabinoside), gemcitabine, mercaptopurine (6-mercaptopurine, 6-MP), thioguanine (6-thioguanine, TG), pentostatin (2′

-deoxycoformycin, deoxycoformycin), cladribine, fludarabine, amsacrine, vinblastine (VLB), vincristine, paclitaxel, docetaxel (Taxotere);

epipodophyllotoxin, etoposide, teniposide, camptothecins, topotecan, irinotecan, dactinomycin (actinomycin D), daunorubicin (daunomycin, rubidomycin), doxorubicin, bleomycin, mitomycin (mitomycin C), idarubicin, epirubicin, L-asparaginase, interferon alpha, interlelukin 2, buserelin, adrenocorticosteroids, prednisone, progestins, hydroxyprogesterone caproate, medroxyprogesterone acetate, megestrol acetate;

estrogens, diethylstilbestrol, ethinyl estradiol, tamoxifen, anastrozole, testosterone propionate, fluoxymesterone, flutamide, bicalutamide, leuprolide, thalidomide, cisplatin (cis-DDP), oxaliplatin, carboplatin, anthracenediones, mitoxantrone, hydroxyurea;

methylhydrazine, procarbazine (N-methylhydrazine, MIH), mitotane (o,p′

-DDD), aminoglutethimide, bexarotene;

tyrosine kinase inhibitors, imatinib, antiangiogenic agents and biological response modifiers.

2. A method for predicting the response of a tumor in an animal to a chemotherapeutic regimen comprising:

(a) applying a first anti-SPARC antibody to a histologic section of the tumor, wherein the first anti-SPARC antibody preferentially immunostains SPARC in tumor cells;

(b) applying a second anti-SPARC antibody to the histologic section of (a) or a second histologic section of the tumor, wherein the second anti-SPARC antibody preferentially immunostains SPARC in fibroblasts; and

(c) predicting a positive response to the chemotherapeutic regimen if the second anti-SPARC antibody immunostains the histologic section or sections.

5. The method of claim 2, wherein the first anti-SPARC antibody recognizes a SPARC epitope recognized by monoclonal antibody MAB941, and wherein the second antibody recognizes an immunodominant SPARC epitope recognized by polyclonal antibody AF941.

6. The method of claim 2, wherein the first anti-SPARC antibody is MAB941, and wherein the second antibody is AF941.

7. A method of treating a tumor in an animal with a chemotherapeutic regimen comprising:

(a) applying a first anti-SPARC antibody to a histologic section of the tumor, wherein the first anti-SPARC antibody preferentially immunostains SPARC in tumor cells;

(b) applying a second anti-SPARC antibody to the histologic section of (a) or a second histologic section of the tumor, wherein the second anti-SPARC antibody preferentially immunostains SPARC in fibroblasts; and

(c) administering the chemotherapeutic regimen if the first anti-SPARC antibody and the second anti-SPARC antibody immunostain the histologic section or sections.

8. The method of claim 7, wherein the first anti-SPARC antibody recognizes a SPARC epitope recognized by monoclonal antibody MAB941, and wherein the second antibody recognizes an immunodominant SPARC epitope recognized by polyclonal antibody AF941.

9. The method of claim 7, wherein the first anti-SPARC antibody is MAB941, and wherein the second antibody is AF941.

10. A method for predicting the response of a tumor in an animal to a chemotherapeutic regimen comprising:

(a) applying an anti-SPARC antibody to a histologic section of the tumor, wherein the anti-SPARC antibody recognizes a SPARC epitope recognized by monoclonal antibody MAB941;

(b) predicting a poor response to the chemotherapeutic regimen if the anti-SPARC antibody immunostains the histologic section or sections.

11. The method of claim 10, wherein the anti-SPARC antibody is MAB941.

12. A method for predicting the response of a tumor in an animal to a chemotherapeutic regimen comprising:

(a) applying an anti-SPARC antibody to the histologic section of (a) or a second histologic section of the tumor, wherein the second antibody recognizes an immunodominant SPARC epitope recognized by polyclonal antibody AF941; and

(b) predicting a positive response to the chemotherapeutic regimen if the anti-SPARC antibody immunostains the histologic section or sections.

13. The method of claim 12, wherein anti-SPARC second antibody is AF941.

16-24. -24. (canceled)