Compositions and methods for the prevention and treatment of cardiovascular diseases

Inventors

Van Wyk, Henk • Van Wyk, Mariette • Krebs, Trace • Lange, Peter • Denomme, Brian • Volk, Michael A.

Assignees

Noventis Inc • Reven Pharmaceuticals Inc

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Publication Number

US-9775798-B2

Patent

Publication Date

2017-10-03

Expiration Date


Abstract

Compositions comprising electro-activated aqueous solutions and methods for the prevention and treatment of dysfunctional cardiovascular conditions are provided.

Core Innovation

The invention relates to electro-activated aqueous compositions and methods for treating dysfunctional cardiovascular conditions in a subject. The electro-activated solution is characterized by a stable oxidation-reduction potential (ORP) in the range between -250 mV and +2500 mV for a period of at least 12 months, a conductivity in the range between 11 and 15 mS/cm, and a pH in the range between 6.5 and 7.6.

The composition comprises electro-activated water together with magnesium sulfate hexahydrate, sodium bicarbonate, ascorbic acid, niacinamide, pyridoxine HCl, calcium D pantothenate, thiamin HCl, riboflavin, cyanocobalamin, and 2-diethylaminoethanol in defined ranges. The stable composition is suitable for maintenance of the electro-activated solution characteristics over an extended period.

The treatment method administers the stable composition by parenteral injection to a subject having a calcium score of 46 and above or diagnosed with Buerger’s Disease. The cited administration routes include intravenous and intra-arterial delivery, and the content includes a mechanistic rationale linking electro-activated solutions to reactive oxygen species (ROS) and cellular membrane effects, including trans membrane potential and related cellular permeability.

Claims Coverage

The document contains one independent claim directed to a parenteral treatment method using a stable electro-activated solution with specified ORP, conductivity, and pH values, together with defined ingredient ranges. Dependent claims refine the treated population and administration route, specifically narrowing delivery to intra-arterial or intravenous and targeting subjects with calcium score ≥46 or with a Buerger’s Disease diagnosis.

Parenteral administration of stable electro-activated solution with defined ORP, conductivity, and pH

Administering by parenteral injection to a subject a stable composition comprising a therapeutically effective amount of an electro-activated solution having ORP between -250 mV and +2500 mV for a period of at least 12 months, conductivity between 11 and 15 mS/cm, and pH between 6.5 and 7.6.

Defined ingredient ranges for an electro-activated composition

The electro-activated solution comprises magnesium sulfate hexahydrate, sodium bicarbonate, ascorbic acid, niacinamide, pyridocxin HCL, calcium D pantothenate, thiamin HCl, riboflavin, cyanocobalamin, 2-di-ethylaminoethanol, and electro-activated water in defined ranges.

Treatment target based on calcium score ≥46 or Buerger’s Disease

Treating a subject having a calcium score of 46 and above or diagnosed with Buerger’s Disease.

Intra-arterial or intravenous administration routes

Administering the composition of the method by an intra-arterial or intravenous route.

Claim coverage centers on administering a stable electro-activated solution composition by parenteral injection, where the electro-activated solution is defined by long-term stable ORP (-250 mV to +2500 mV for at least 12 months), conductivity (11–15 mS/cm), and pH (6.5–7.6), and is further defined by specific ingredient ranges. Dependent claims narrow the treated population to calcium score ≥46 or refine the parenteral delivery route to intra-arterial or intravenous and apply the method to subjects diagnosed with Buerger’s Disease.

Stated Advantages

The stable composition maintains the electro-activated solution characteristics over an extended period.

Documented Applications

Treating a subject having a calcium score of 46 and above using a stable electro-activated solution administered by parenteral injection.

Treating subjects diagnosed with Buerger’s Disease using a stable electro-activated solution administered by parenteral injection, including intravenous or intra-arterial routes.

Use of coronary calcium scan including Agatston calcium score to assess calcium-score outcomes, including reported calcium-score changes in subjects with baseline calcium score ≥46.

Reported angina remission and improved angiograms associated with the administration of the claimed stable electro-activated compositions.

Reported Buerger’s disease symptom resolution associated with the administration of the claimed stable electro-activated compositions.

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