Prevention or treatment of disease states due to metal dis-homeostasis via administration of Posiphen to healthy or sick humans
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Publication Number
US-11596621-B2
Publication Date
2023-03-07
Expiration Date
Abstract
The invention relates in part to a method of maintaining heavy metal homeostasis in healthy humans, comprising chronically administering to healthy humans a pharmaceutical composition consisting of from about 1 mg to less than about 200 mg of Posiphen or a pharmaceutically acceptable salt thereof together with one or more pharmaceutically acceptable excipients, on a once a day basis. By virtue of this method, prophylactic treatment of a potential disease state such as a neurodegenerative disease, cardiovascular homeostasis, cancer, vital organ homeostasis, and the like. The invention also relates in part to a method of restoring heavy metal homeostasis in sick patients, comprising chronically administering to a sick patient a pharmaceutical composition consisting of from about 1 mg to less than about 200 mg of Posiphen or a pharmaceutically acceptable salt thereof together with one or more pharmaceutically acceptable excipients, on a once a day basis. By virtue of this method, treatment of a potential disease state such as a neurodegenerative disease, cardiovascular disease, cancer, vital organ dysfunction and heavy metal dis-homeostasis, and the like.
Core Innovation
The invention relates to a method of maintaining heavy metal homeostasis avoiding the effect of toxic levels of a heavy metal in cells in a healthy human, or restoring heavy metal homeostasis in a sick human patient. The method is based on chronically administering a Posiphen-containing pharmaceutical composition to a human who is at risk of or has abnormally high levels of a heavy metal and who has not been diagnosed with a neurological disease. The composition includes Posiphen in a specified amount, pharmaceutically acceptable salts thereof, and one or more pharmaceutically acceptable excipients in a therapeutically effective amount.
The disclosed approach targets heavy metals selected from iron, copper, zinc, and combinations, with emphasis on chronic administration schedules within a daily frequency range. The invention aims to maintain heavy metal homeostasis in the human and avoid the effects of toxic levels of the heavy metal, and in some descriptions the heavy metal is iron.
Mechanistic context is provided by describing Posiphen as associated with iron-responsive translational regulation involving IRP1 and iron-responsive element (IRE) binding in relation to APP mRNA 5′UTR. The disclosure further associates the approach with proteins including APP/Aβ, Tau, SNCA/aSYN/NAC, SOD1, HTT, TDP43, and C9orf72, with selective activity under stressed, dividing, or iron-dishomeostasis conditions and no effect in normal fully differentiated cells.
Claims Coverage
The independent claim covers chronic administration of a Posiphen-based pharmaceutical composition for maintaining or restoring heavy metal homeostasis in healthy-at-risk or sick humans, avoiding toxic effects of elevated heavy metal levels, with heavy metals selected from iron, copper, zinc, or combinations. Three main inventive features are presented, with dependent refinements on dose, route, heavy metal selection, and outcomes.
Chronically administering Posiphen composition for heavy metal homeostasis
A method of maintaining heavy metal homeostasis avoiding the effect of toxic levels of a heavy metal in cells in a healthy human or restoring heavy metal homeostasis in a sick human patient by chronically administering to a human who is at risk of or has abnormally high levels of a heavy metal and who has not been diagnosed with a neurological disease a pharmaceutical composition.
Specified daily Posiphen dosing with salts and excipients
The pharmaceutical composition consists of from about 1 mg to less than about 200 mg of Posiphen together with pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients in a therapeutically effective amount, administered from 1 to 4 times daily.
Selecting the heavy metal from iron, copper, zinc or combinations
The heavy metal is selected from the group consisting of iron, copper, zinc and a combination of any of the foregoing.
Administration route selected from oral and listed non-oral routes
Chronically administering Posiphen using an administration route chosen from oral, parenteral, sublingual, suppository, nasal, topical, transdermal, or implant under the skin.
Therapeutic outcomes for cardiovascular and neurodegenerative disease
Administering a therapeutically effective amount of Posiphen and pharmaceutically acceptable salts to stop, slow, or delay the onset of cardiovascular disease or the progression of a neurodegenerative disease or condition in a human.
Toxic effects mediated by named protein entities
Toxic effects from producing high levels of a heavy metal in a human are mediated by producing high levels of a protein selected from APP, Aβ, SOD proteins, SNCA, NAC, TSE amyloid plaque, HTT, Tau, alpha-synuclein, TDP43, or C9orf72.
Overall claim coverage centers on chronic administration of a Posiphen pharmaceutical composition, with salts and excipients, at specified daily frequency and Posiphen amount to maintain or restore heavy metal homeostasis and avoid toxic effects. Dependent refinements address specific heavy metals, selected administration routes, therapeutic outcomes for cardiovascular and neurodegenerative diseases, and mediation of toxic effects by named protein entities.
Stated Advantages
Maintains heavy metal homeostasis in the human.
Avoids the effects of toxic levels of the heavy metal in the human.
Restores heavy metal homeostasis in a sick human patient.
Stops, slows, or delays the onset of cardiovascular disease.
Stops, slows, or delays the progression of a neurodegenerative disease or condition in a human.
Documented Applications
Prophylaxis in healthy humans at risk of abnormally high levels of heavy metals, including the maintenance of vital organ homeostasis.
Treatment in sick patients to restore heavy metal homeostasis and avoid toxic effects of elevated heavy metals.
Disease targeting for neurodegenerative diseases, including specified neurodegenerative disease protein mediators such as APP/Aβ, Tau, SNCA/aSYN/NAC, SOD1, HTT, TDP43, and C9orf72, and for cardiovascular disorders.
Cancer-related targeting, as described in the disclosure context.
Vital organ homeostasis use cases, including organ/tissue-level readouts such as retinal protection and hippocampus/cortex effects in described settings.
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