Use of 2 anti-SPARC antibodies to predict response to chemotherapy for pancreatic adenocarcinoma

• US 9,091,697 B2
• Filed: 02/25/2013
• Issued: 07/28/2015
• 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
• Primary Examiner(s): STOICA, ELLY GERALD
• Application Number:
  US13/775,980
• Publication Number:
  US 20130172261A1
• Time in Patent Office: 883 Days
• US Class Current: 1/1
• 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 of treating a pancreatic adenocarcinoma in an animal with a chemotherapeutic regimen comprising paclitaxel and gemcitabine, wherein said method comprises:

(a) obtaining histologic sections from a tumor resulting from the pancreatic adenocarcinoma,

(b) applying a first anti-SPARC antibody to a first histologic section of the tumor, wherein the first anti-SPARC antibody preferentially immunostains SPARC in tumor cells and wherein the first anti-SPARC antibody recognizes a SPARC epitope recognized by monoclonal antibody MAB941;

(c) applying a second anti-SPARC antibody to the first histologic section of (a) or a second histologic section of the tumor, wherein the second anti-SPARC antibody preferentially immunostains SPARC in fibroblasts and wherein the second anti-SPARC antibody recognizes an immunodominant SPARC epitope recognized by polyclonal antibody AF941

(d) determining whether the first anti-SPARC antibody immunostains any component of the tumor;

(e) determining whether the second anti-SPARC antibody immunostains any component of the tumor; and

(f) treating the animal by

(i) administering the chemotherapeutic regimen if the tumor cells of the pancreatic adenocarcinoma are immunostained with the second anti-SPARC antibody, but not the first anti-SPARC antibody and the immunostaining by the first anti-SPARC antibody of any other component of the tumor has an intensity of 2+ or less;

(ii) not administering the chemotherapeutic regimen if first anti-SPARC antibody immunostains the tumor cells or immunostains any other component of the tumor with an intensity of 3+; and

(iii) not administering the chemotherapeutic regimen if second anti-SPARC antibody does not stain the tumor cells.

2. The method of claim 1, wherein the chemotherapeutic regimen comprises nanoparticulate, albumin bound paclitaxel.

3. The method of claim 1, wherein the animal is a human patient.