Method of treating neurological conditions with oleandrin

Inventors

ADDINGTON, Otis C. • Newman, Robert A.

Assignees

Phoenix Biotechnology Inc

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Publication Number

US-9877979-B2

Patent

Publication Date

2018-01-30

Expiration Date


Abstract

A method of treating neurological condition in a subject by administration of a cardiac glycoside is provided. Alzheimer's disease, Huntington's disease or stroke are treated by administering a therapeutically effective amount of cardiac glycoside to a subject. The cardiac glycoside can be present in a dosage form.

Core Innovation

The disclosed invention relates to treating, improving clinical status, and preventing or reducing the incidence of neurological conditions in a subject or a population at risk. The methods include administering a therapeutically effective dose of an oleandrin-containing composition sufficient to provide a plasma concentration of oleandrin in the range of 0.005 to 10 ng/ml.

The invention further includes methods for improving the clinical status of a statistically significant number of subjects in a population having a neurological condition. In addition, the invention provides a method for reducing the incidence of occurrence of a neurological condition in a population of subjects at risk by administering the oleandrin-containing composition on a recurring basis for an extended period of time to maintain the plasma oleandrin concentration in the range of 0.005 to 10 ng/ml.

For stroke, a time-delayed method is provided in which oleandrin-containing composition is administered within an acceptable delay period after a subject has suffered the stroke. The oleandrin-containing composition is described as being used alone or further comprising one or more other therapeutically effective agents.

Claims Coverage

The provided independent claims cover four core therapeutic use categories: treatment of a neurological condition in a subject, improvement of clinical status in a population, reduction of incidence in an at-risk population, and a time-delayed stroke treatment. Across these independent claims, the shared inventive element is administering an oleandrin-containing composition to achieve plasma oleandrin in the range of 0.005 to 10 ng/ml, with certain claims further requiring statistical-population improvement, recurring administration for extended periods, or an acceptable delay period after stroke.

Treating a neurological condition via plasma oleandrin concentration range

Administering to a subject in need a therapeutically effective dose of an oleandrin-containing composition sufficient to provide a plasma concentration of oleandrin in the range of 0.005 to 10 ng/ml.

Improving clinical status of a statistically significant number of subjects

Administering to subjects in a population having a neurological condition a therapeutically effective dose of an oleandrin-containing composition sufficient to provide a plasma concentration of oleandrin in the range of 0.005 to 10 ng/ml to improve the clinical status of a statistically significant number of subjects.

Reducing incidence of a neurological condition by recurring extended administration

Administering a therapeutically effective dose of an oleandrin-containing composition on a recurring basis for an extended period of time to one or more subjects in a population of subjects at risk, where the dose provides a plasma concentration of oleandrin in the range of 0.005 to 10 ng/ml thereby reducing the incidence of the neurological condition in the population.

Time-delayed treating of stroke with plasma oleandrin concentration range

Within an acceptable delay period after a subject has suffered the stroke, administering a therapeutically effective dose of oleandrin-containing composition sufficient to provide a plasma concentration of oleandrin in the range of 0.005 to 10 ng/ml.

Across the independent claims, the claim coverage centers on achieving a specified plasma oleandrin concentration range (0.005 to 10 ng/ml) by administering an oleandrin-containing composition, applied to treatment of a neurological condition in an individual subject, improvement of clinical status in a statistically significant number of subjects, reduction of incidence in an at-risk population via recurring extended administration, and time-delayed treatment of stroke within an acceptable delay period.

Stated Advantages

Improving the clinical status of a statistically significant number of subjects in a population having a neurological condition.

Reducing the incidence of occurrence of a neurological condition in a population of subjects at risk.

Treating stroke by a time-delayed method within an acceptable delay period after suffering the stroke.

Treating a neurological condition in a subject by administering an oleandrin-containing composition.

Documented Applications

Treating neurological conditions in a subject, including stroke, Huntington’s disease, and Alzheimer’s disease.

Improving the clinical status of a statistically significant number of subjects with a neurological condition.

Reducing the incidence of neurological conditions in a population of subjects at risk by recurring administration for an extended period.

Time-delayed treatment of stroke within an acceptable delay period after the subject has suffered the stroke.

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