IP Library Granted Patent US 9,901,574
Granted Patent B2
US 9,901,574 · App. 15/134,051 · Granted Feb 27, 2018

Predicting response to alvocidib by mitochondrial profiling

Inventors: Steven L. Warner (Sandy, UT); David J. Bearss (Alpine, UT)
Assignee: Tolero Pharmaceuticals, Inc.
A61K31/453A61K31/136A61K31/7068C12Q1/6886G01N33/5011G01N33/5079G01N33/5748G01N33/57426C12Q2600/106C12Q2600/158G01N2333/82G01N2800/52
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Quick Facts
Patent No.
US 9,901,574
App. No.
15/134,051
Granted
Feb 27, 2018
Kind
B2
Abstract

The present disclosure provides diagnostic methods useful for predicting a patient's response to alvocidib and guiding a physician decision to administer alvocidib to the patient.

Claims (15)

1. A method for treating a hematologic cancer in a patient in need thereof, the method comprising

administering a treatment regimen comprising alvocidib to a patient having a bone marrow NOXA priming value of at least 15%, the bone marrow NOXA priming value having been obtained by an in vitro method comprising:

i) permeabilizing a hematologic cancer cell obtained from bone marrow of the patient, thereby producing a permeabilized hematologic cancer cell; and

ii) contacting the permeabilized hematologic cancer cell with a NOXA BH3 domain peptide.

2. The method of claim 1 , wherein the patient has a bone marrow NOXA priming value of least 20%.

3. The method of claim 1 , wherein the patient has a bone marrow NOXA priming value of at least 30%.

4. The method of claim 1 , wherein the patient has a bone marrow NOXA priming value of at least 40%.

5. The method of claim 1 , wherein the patient's cytogenetics are high risk.

6. The method of claim 1 , wherein the treatment regimen is administered to the patient only if the patient has a prior history of myelodysplasic syndrome (MDS).

7. The method of claim 1 , wherein the NOXA BH3 domain peptide is used at a concentration ranging from 0.1 μM to 200 μM.

8. The method of claim 1 , wherein the hematologic cancer is selected from the group consisting of acute myelogenous leukemia (AML), multiple myeloma, follicular lymphoma, acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia, and non-Hodgkin's lymphoma.

9. The method of claim 8 , wherein the hematological cancer is acute myelogenous leukemia (AML).

10. The method of claim 1 , wherein the hematologic cancer is myelodysplasic syndrome (MDS) or chronic lymphocytic leukemia (CLL).

11. The method of claim 1 , wherein the treatment regimen comprises alvocidib, cytarabine, and mitoxantrone (FLAM).

12. The method of claim 1 , wherein the bone marrow sample is derived from the biopsy of a patient with multiple myeloma, acute myelogenous leukemia, acute lymphocytic leukemia, chronic lymphogenous leukemia, mantle cell lymphoma, diffuse large B-cell lymphoma or non-Hodgkin's lymphoma.

Assignments (5)
CHANGE OF NAME Recorded Apr 27, 2022
From: SUMITOMO DAINIPPON PHARMA ONCOLOGY, INC.
To: SUMITOMO PHARMA ONCOLOGY, INC.
Reel/Frame 059809/0557 →
MERGER Recorded Jul 10, 2020
From: TOLERO PHARMACEUTICALS, INC.
To: BOSTON BIOMEDICAL, INC.
Reel/Frame 053181/0114 →
CHANGE OF NAME Recorded Jul 10, 2020
From: BOSTON BIOMEDICAL, INC.
To: SUMITOMO DAINIPPON PHARMA ONCOLOGY, INC.
Reel/Frame 053181/0133 →
SECURITY INTEREST Recorded Nov 17, 2016
From: TOLERO PHARMACEUTICALS, INC.
To: SUMITOMO DAINIPPON PHARMA CO., LTD.
Reel/Frame 040362/0884 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2016
From: WARNER, STEVEN L.; BEARSS, DAVID J.
To: TOLERO PHARMACEUTICALS, INC.
Reel/Frame 039601/0719 →
Continuity (2)
Provisional Application 62150138 · Apr 20, 2015
Related Publication 20160303101A1 · Oct 20, 2016