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Publication Number

US-12005049-B2

Patent

Publication Date

2024-06-11

Expiration Date


Abstract

A method of preventing metastasis of a cancer in a patient in need thereof includes administering to the patient a therapeutically effective amount of ibudilast, or a pharmaceutical salt thereof.

Core Innovation

The invention provides methods of preventing, ameliorating, or minimizing metastasis of eye cancer in a patient in need thereof. The methods comprise administering to the patient a therapeutically effective amount of ibudilast, or a pharmaceutically acceptable salt thereof, with the focus on preventing metastatic spread and reducing or improving metastatic disease burden.

The invention further addresses metastasis in an eye cancer context, including uveal melanoma. Therapeutic use is described in terms of providing a therapeutically effective amount of ibudilast, or a pharmaceutically acceptable salt, to achieve effects directed to cancer metastasis prevention, amelioration, or minimization.

The described subject matter additionally supports treatment frameworks in which ibudilast is used as an anti-inflammatory and immune-modulating agent to affect pathways associated with metastasis-related processes. The patent content characterizes ibudilast in connection with PDE inhibition, TLR4 antagonism, and MIF inhibition, and relates these effects to evidence using exosome-stimulated migration/wound-healing assays and an in vivo metastatic uveal melanoma mouse model with bioluminescence and histology.

Claims Coverage

The independent claim provides the core coverage for preventing, ameliorating, or minimizing metastasis of eye cancer by administering ibudilast at a therapeutically effective amount, or a pharmaceutically acceptable salt. Dependent claims refine coverage with inventive features related to the eye cancer subtype and dosing constraints, including daily dose ranges, discrete daily dose values, and single-versus-split dosing.

Preventing, ameliorating, or minimizing eye cancer metastasis with ibudilast

Administering to the patient a therapeutically effective amount of ibudilast, or a pharmaceutically acceptable salt thereof, for preventing, ameliorating, or minimizing metastasis of eye cancer in a patient in need thereof.

Uveal melanoma eye cancer

Administering ibudilast, or a pharmaceutically acceptable salt, for treating an eye cancer that is uveal melanoma.

Minimum daily dose of 30 mg/day

Administering ibudilast, or a pharmaceutically acceptable salt, in a therapeutically effective amount of at least 30 mg per day.

Daily dose range of 30 mg to 200 mg

Specifying that a therapeutically effective daily amount of ibudilast, or a pharmaceutically acceptable salt thereof, is 30 mg to 200 mg per day.

Discrete allowable daily dose values

Administering a therapeutically effective daily amount of ibudilast, or a pharmaceutically acceptable salt, selected from the listed dose range values in mg/day.

Single dose or split into 2 to 4 doses

Administering a therapeutically effective amount either as a single dose or split into two, three, or four doses.

Overall, the claim set is directed to metastasis prevention, amelioration, or minimization of eye cancer using ibudilast, or pharmaceutically acceptable salts, with coverage further refined to uveal melanoma and to therapeutically effective daily dosing constraints, including minimum and range limits, discrete daily dose selections, and single-versus-split dosing.

Stated Advantages

Prevention, amelioration, or minimization of metastasis of eye cancer.

Documented Applications

Methods for preventing, ameliorating, or minimizing metastasis of eye cancer in a patient, including uveal melanoma.

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