SPARC and methods of use thereof

• US 9,671,406 B2
• Filed: 01/30/2015
• Issued: 06/06/2017
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Abraxis Bioscience LLC (Bristol-Myers Squibb Company)
• Original Assignee: Abraxis Bioscience LLC (Bristol-Myers Squibb Company)
• Inventors: Trieu, Vuong, Soon-Shiong, Patrick, Desai, Neil P.
• Primary Examiner(s): Dent, Alana Harris
• Application Number:
  US14/610,099
• Publication Number:
  US 20150141343A1
• Time in Patent Office: 858 Days
• Field of Search: None
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: G01N 2333/4727 Calcium binding proteins, e.g. calmodulin
• CPC Class Codes: G01N 2333/71 for growth factors; for growth regulators
• CPC Class Codes: G01N 2333/91205 Phosphotransferases in general
• 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 33/574 for cancer
• CPC Class Codes: G01N 33/57407 Specifically defined cancers
• 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 33/57488 involving compounds identifable in body fluids
• CPC Class Codes: G01N 33/57492 involving compounds localized on the membrane of tumor or cancer cells
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

The invention provides methods for predicting or determining the response of a mammalian tumor to a chemotherapeutic agent and for treating a mammalian tumor comprising detecting and quantifying the SPARC protein or RNA in a sample isolated from the mammal. The invention further provides kit for predicting the response of a mammalian tumor to a chemotherapeutic agent, comprising a means for the isolation of protein or RNA from the tumor, a SPARC protein or RNA detection and quantification means, control RNAs, and rules for predicting the response of the tumor based on the level of SPARC protein or RNA in tumor.

Claims

1. A method of treating a cancer of the breast, lung, colon, prostate, or head and neck in a mammal with a chemotherapeutic regimen or other anticancer regimen comprising paclitaxel, said method comprising:

(a) isolating a biological sample of cancerous cells from the mammal, (b) detecting the expression of SPARC protein in the biological sample, (c) quantifying the amount of SPARC protein in the biological sample to determine whether the biological sample is positive for SPARC expression, (d) detecting the expression of Her2 protein in the biological sample, (e) quantifying the amount of Her2 protein in the biological sample to determine if the biological sample is positive for Her2 expression, and (f) if the biological sample is positive for SPARC expression and positive for Her2 expression, administering a therapeutically effective amount of the chemotherapeutic regimen or other anticancer regimen to the mammal.

2. The method of claim 1, wherein the paclitaxel comprises particles of protein-bound paclitaxel.

3. The method of claim 2, wherein the protein component of the protein-bound drug particles comprises albumin.

4. The method of claim 1, wherein more than 50% of the paclitaxel is in nanoparticle form.

5. The method of claim 1, wherein the paclitaxel dose is from about 30 mg/m² to about 1000 mg/m² with a dosing cycle of about 3 weeks.

6. The method of claim 1, wherein the mammal is a human.

7. The method of claim 1, wherein said detecting the expression of SPARC protein in the biological sample, quantifying the amount of SPARC protein in the biological sample, detecting the expression of Her2 protein in the biological sample, and quantifying the amount of Her2 protein in the biological sample are done by immunohistochemical staining.