Methods of treating oral mucositis

Inventors

Rothstein, David M.Murphy, ChrisWong, VivienKazo, Glenn

Assignees

Biossil IncActivbiotics Inc

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Publication Number

US-11612608-B2

Patent

Publication Date

2023-03-28

Expiration Date


Abstract

Methods and kits for treating oral mucositis are disclosed. The treatment comprises administering to a patient in need thereof a Reactive Oxygen Species scavenger in a pharmaceutically acceptable formulation.

Core Innovation

The invention relates to treating mucositis affecting the mucosal lining of the gastrointestinal tract by parenterally administering a therapeutically sufficient dose of a pentaaza macrocyclic ring complex to a mammal afflicted with cancer. The mucositis results from delivered chemotherapy and/or radiation therapy, and the dose is administered on the day before or the day of, but prior to or simultaneous with, the mammal receiving either or both chemotherapy treatment and radiation therapy.

The pentaaza macrocyclic ring complex is represented by a formula in which W is an unsubstituted pyridino moiety, U and V are trans-cyclohexanyl fused rings, M is Mn2+ or Mn3+, and X, Y and Z are independently selected from specified anion options. The substituents R1, R2, R'2, R3 through R10, and R'5, R'6, R'9 are each independently selected from a defined set including hydrogen, alkenyl, alkyl, alkynyl, aryl, cycloalkenyl, cycloalkyl, and heterocyclyl, among others, and n is an integer from 0 to 3.

The method does not require additional administration of the pentaaza macrocyclic ring complex after either or both of the chemotherapy treatment and radiation therapy doses. Documented discussion also includes potential cancer treatment use where the pentaaza macrocyclic ring complex prevents or reduces oral mucositis during chemotherapy and/or radiation, optionally in combination with other ROS scavengers and antioxidant-pathway modulation.

Claims Coverage

The provided material includes one independent claim. The claim centers on parenteral administration of a therapeutically sufficient pentaaza macrocyclic ring complex to lessen cancer-related gastrointestinal mucositis caused by chemotherapy and/or radiation, with the compound defined by a specific formula and the dosing limited to a pre- or simultaneous-treatment window without further doses afterward.

Parenteral administration to lessen gastrointestinal mucositis

Parenterally administering a therapeutically sufficient dose of a pentaaza macrocyclic ring complex to a mammal afflicted with cancer to lessen the severity of mucositis affecting the mucosal lining of the gastrointestinal tract, wherein the mucositis results from delivered chemotherapy and/or radiation therapy.

Timing before or during chemotherapy and/or radiation without further doses

The dose is administered on the day before or the day of, but prior to or simultaneous with, the mammal receiving either or both chemotherapy treatment and radiation therapy, without additional doses after either treatment.

Defined pentaaza macrocyclic ring complex composition

The pentaaza macrocyclic ring complex is represented by a formula in which W is an unsubstituted pyridino moiety, U and V are trans-cyclohexanyl fused rings, M is Mn2+ or Mn3+, and X, Y and Z are independently selected from specified anion options, with the recited substituent and n selections.

The independent claim combines parenteral, therapeutically sufficient administration of a formula-defined pentaaza macrocyclic ring complex, timing on the day before or the day of chemotherapy and/or radiation and prior to or simultaneous with treatment, to lessen mucositis severity without further dosing afterward.

Stated Advantages

Lessen the severity of mucositis affecting the mucosal lining of the gastrointestinal tract resulting from delivered chemotherapy and/or radiation dose.

Do so without requiring additional doses of the pentaaza macrocyclic ring complex after either or both chemotherapy treatment and radiation therapy.

Documented Applications

Treatment of cancer-associated mucositis affecting the mucosal lining of the gastrointestinal tract caused by chemotherapy and/or radiation therapy.

Potential use in cancer treatment where the pentaaza macrocyclic ring complex prevents or reduces oral mucositis during chemotherapy and/or radiation.

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