IP Library Granted Patent US 10,655,185
Granted Patent B2
US 10,655,185 · App. 15/525,787 · Granted May 19, 2020

Methods for diagnosis and prognosis of epithelial tumors

Inventors: Ratna Chakrabarti (Winter Springs, FL); Richard Ottman (Orlando, FL); Domenico Coppola (Tampa, FL); Nupam Mahajan (Tampa, FL)
Assignees: H. Lee Moffitt Cancer Center and Research Institute, Inc.; University of Center Florida Research Foundation, Inc.
C12Q1/6886C12Q2600/106C12Q2600/112C12Q2600/118C12Q2600/158
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Quick Facts
Patent No.
US 10,655,185
App. No.
15/525,787
Granted
May 19, 2020
Kind
B2
Abstract

A biomarker is disclosed that can distinguish aggressive epithelial tumors in a tissue biopsy from, for example, normal, hyperplastic, and benign neoplastic tumors. The biomarker can also identify epithelial tumors that have become resistant to hormone therapy. Therefore, methods are disclosed for providing diagnosis and prognosis of a subject having, or suspected of having, an epithelial tumor, such as a prostate tumor.

Claims (8)

1. A method for providing a prognosis of a subject with prostate cancer and treating a subject with a poor prognosis, comprising assaying a biopsy sample comprising basal cells and optimally comprising luminal cells from the subject for the level of FGD1-related F-actin binding protein (Frabin/FGD4) protein, FGD4 gene expression, or a combination thereof, and comparing the level to control values, wherein an elevated level of Frabin or FGD4 in the luminal cells and a concomitant absence of Frabin or FGD4 in basal cells is an indication of a poor prognosis; and further treating said subject with an elevated level of Frabin or FGD4 by administering to the subject a chemotherapeutic.

2. The method of claim 1 , wherein an elevated level of Frabin or FGD4 in the sample is an indication of androgen independent prostate cancer.

3. The method of claim 1 , further comprising androgen ablation if an evaluated level of Frabin or FGD4 in the cancer is detected.

4. The method of claim 1 , wherein the chemotherapeutic is selected from the group consisting of docetaxel (Taxotere®), paclitaxel (Taxol®), mitoxantrone (Novantrone®), carboplatin (Paraplatin®), and vinorelbine (Navelbine®).

5. The method of any one of claims 3 or 4 , further comprising administering to the subject an angiogenesis inhibitor if an elevated level of Frabin or FGD4 in the sample is detected.

6. The method of claim 5 , wherein the angiogenesis inhibitor comprises bevacizumab (Avastin®).

7. A method for providing a prognosis of a subject with prostate cancer who is receiving primary hormonal therapy and treating a subject who has been given a poor prognosis accordingly, comprising assaying a biopsy sample comprising basal cells and optimally comprising luminal cells from the subject for the level of FGD1-related F-actin binding protein (Frabin/FGD4) protein, FGD4 gene expression, or a combination thereof, and comparing the level to control values, wherein an elevated level of Frabin or FGD4 in the luminal cells and a concomitant absence of Frabin or FGD4 in basal cells is an indication of a poor prognosis; and terminating primary hormonal therapy when the subject has an elevated level of Frabin or FGD4 in the sample.

8. The method of claim 7 , wherein the primary hormonal therapy is an antiandrogen, such as Bicalutamide (Casodex®), Flutamide (Drogenil®), or Enzalutamide (Xtandi®).

Assignments (3)
CONFIRMATORY LICENSE Recorded Nov 18, 2019
From: UNIVERSITY OF CENTRAL FLORIDA
To: THE GOVERNMENT OF THE UNITED STATES, AS REPRESENTED BY THE SECRETARY OF THE ARMY
Reel/Frame 051042/0264 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 27, 2017
From: COPPOLA, DOMENICO; MAHAJAN, NUPAM
To: H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE, INC.
Reel/Frame 044226/0145 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 27, 2017
From: CHAKRABARTI, RATNA; OTTMAN, RICHARD
To: UNIVERSITY OF CENTRAL FLORIDA RESEARCH FOUNDATION, INC.
Reel/Frame 044226/0213 →
Continuity (3)
Provisional Application 62077859 · Nov 10, 2014
Provisional Application 62093224 · Dec 17, 2014
Related Publication 20170335403A1 · Nov 23, 2017