IP Library Granted Patent US 10,722,577
Granted Patent B2
US 10,722,577 · App. 14/402,875 · Granted Jul 28, 2020

Methods for treating GI syndrome and graft versus host disease

Inventors: Jimmy Andrew Rotolo (Port Washington, NY); Richard N. Kolesnick (New York, NY)
Assignee: Sloan Kettering Institute for Cancer Research
A61K39/39533A61K31/4709A61K31/496A61K31/55A61K39/39541A61K45/06C07K16/18C07K16/44C07K2317/24C07K2317/76
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Quick Facts
Patent No.
US 10,722,577
App. No.
14/402,875
Granted
Jul 28, 2020
Kind
B2
Abstract

It has been discovered that administering therapeutically effective amounts of an antibiotic that kills Gram-negative bacteria, together with an anti-ceramide antibody or anti-ceramide mimetic, treats and prevents an array of diseases mediated by cytolytic T lymphocyte (CTL)-induced killing and/or by damage to endothelial microvasculature, including Radiation GI syndrome, GvHD disease, inflammatory diseases and autoimmune diseases.

Claims (13)

1. A method for treating radiation disease associated with gastrointestinal (GI) damage in a subject, comprising administering a therapeutically effective amount of an anti-ceramide antibody, or an antigen-binding fragment thereof, and a therapeutically effective amount of a fluoroquinolone antibiotic that is effective against Gram-negative bacteria,

wherein the anti-ceramide antibody or antigen-binding fragment comprises a variable heavy (V H ) domain and a variable light (V L ) domain,

wherein the V H domain comprises the V H CDR1 sequence, the V H CDR2 sequence and the V H CDR3 sequence of SEQ ID NO:1 or SEQ ID NO: 6; and

the V L domain comprises the V L CDR1 sequence, V L CDR2 sequence and V L CDR3 sequence of SEQ ID NO:3 or SEQ ID NO: 8; and

wherein the fluoroquinolone antibiotic is selected from the group consisting of Enrofloxacin (Baytril), Ciprofloxacin (i.e., Cipro and Proquin), Enoxacin (i.e., Penetrex), Gatifloxacin (i.e., Gatiflo, Tequin and Zymar), Gemifloxacin (i.e., Factive), Levofloxacin (i.e., Levaquin), Lomefloxacin (i.e., Maxaquin), Moxifloxacin (i.e., Avelox), Norfloxacin (i.e., Noroxin), Ofloxacin (i.e., Floxin), Prulifloxacin, Sparfloxacin (i.e., Zagam), Trovafloxacin, Alatrofloxacin (i.e., Trovan), Danofloxacin (i.e., A180), Difloxacin (i.e., Dicural), Marbofloxacin (i.e., Orbax), Orbifloxacin (i.e., Zeniquin), Flumequine, Fleroxacin, Pefloxacin, Rufloxacin, Balofloxacin, Grepafloxacin, Pazufloxacin, Temafloxacin, Tosufloxacin, Besifloxacin, Clinafloxacin, Sitafloxacin, Ibafloxacin, Pradofloxacin, and Sarafloxacin.

2. The method of claim 1 , wherein the fluoroquinolone antibiotic is selected from the group consisting of Enrofloxacin (Baytril), Ciprofloxacin (i.e., Cipro and Proquin), Gatifloxacin (i.e., Gatiflo, Tequin and Zymar), Levofloxacin (i.e., Levaquin), Lomefloxacin (i.e., Maxaquin), Moxifloxacin (i.e., Avelox), Norfloxacin (i.e., Noroxin), Ofloxacin (i.e., Floxin), Prulifloxacin, Sparfloxacin (i.e., Zagam), Danofloxacin (i.e., A180), Difloxacin (i.e., Dicural), Marbofloxacin (i.e., Orbax), Orbifloxacin (i.e., Zeniquin), Flumequine, Fleroxacin, Pefloxacin, Rufloxacin, Balofloxacin, Grepafloxacin, Pazufloxacin, Temafloxacin, Besifloxacin, Clinafloxacin, Sitafloxacin, Ibafloxacin, Pradofloxacin, and Sarafloxacin.

3. The method of claim 1 , wherein the antibody is a monoclonal antibody.

4. The method of claim 3 , wherein the monoclonal antibody is secreted by a hybridoma derived from spleen cells of a subject immunized with Kaposi Sarcoma (KS) cells.

5. The method of claim 1 , wherein the antibody is a h2A2 humanized mouse monoclonal antibody.

6. The method of claim 5 , wherein the antibody is 2A2 IgG or IgM humanized mouse monoclonal antibody.

7. The method of claim 1 , wherein the antibody and the antibiotic are administered either before or after irradiation of the subject.

8. The method of claim 1 , wherein the effective amount of the anti-ceramide antibody is from about 0.1 mg/kg to about 100 mg/kg, and the effective amount of the antibiotic is from about 0.1 mg/kg to about 100 mg/kg.

9. The method of claim 1 , wherein the antigen-binding fragment is an scFv.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2016
From: ROTOLO, JIMMY ANDREW; KOLESNICK, RICHARD N.
To: SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH
Reel/Frame 040160/0805 →
CONFIRMATORY LICENSE Recorded May 15, 2015
From: SLOAN-KETTERING INST CAN RESEARCH
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 035685/0910 →
Continuity (2)
Provisional Application 61651729 · May 25, 2012
Related Publication 20150216971A1 · Aug 6, 2015