Formulations for personalized methods of treatment
Inventors
Assignees
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Publication Number
US-12220402-B2
Publication Date
2025-02-11
Expiration Date
Abstract
Disclosed herein are formulations and methods of administering formulations to starve cells of nutrients, such as amino acids. The formulations can be substantially devoid of one or more non-essential amino acids. A formulation disclosed herein can be given to a subject to treat a disease, for example, cancer. Removing a particular amino acid or a combination of amino acids from the diet of a subject can lead to improved treatment of various diseases, including cancer. Reduction of amino acid levels in a subject reduces the production of proteins, metabolites, lipids, or nucleic acid that can promote cancer growth and metastasis.
Core Innovation
The invention relates to a composition for treating a patient with cancer in a unit dosage form. The composition comprises glutamate or a salt thereof as a non-essential amino acid that is not part of a polypeptide, together with the essential amino acids histidine and isoleucine, each not part of a polypeptide, and a pharmaceutically acceptable excipient. The formulation is defined by amino-acid deprivation through removal of selected non-essential amino acids.
A defining feature is that the composition is devoid of serine and salts thereof and glycine and salts thereof. In addition to the core amino-acid selection, the formulation examples describe unit dosage or powder forms that omit selected amino acids and optionally include taurine, potassium chloride, magnesium citrate, Mg2+ source components, and K+ source components.
The document also describes personalized cancer treatment using amino-acid deprivation formulations and sachet-based administration mixed into drinks. It further references co-intervention strategies with modified diets that limit amino acids and adjust macronutrient and calorie sources, including low-protein diet and ketogenic-type diet forms, and monitoring of serum amino acids.
Claims Coverage
The provided claim content centers on one independent claim directed to a cancer-treatment unit dosage amino-acid composition, with dependent claims adding optional ingredients and further exclusions. The inventive coverage includes the specific amino-acid selection and the exclusion of serine and glycine, with additional refinements involving taurine and ion source components.
A cancer-treatment unit dosage amino-acid composition with glutamate, histidine, and isoleucine
A composition for treating a patient with cancer comprising in unit dosage form glutamate or a salt thereof as a non-essential amino acid not part of a polypeptide, histidine or a salt thereof and isoleucine or a salt thereof as essential amino acids not part of a polypeptide, and a pharmaceutically acceptable excipient.
Devoid of serine and glycine in the unit dosage composition
The composition is devoid of serine and salts thereof and glycine and salts thereof.
Taurine inclusion within the composition
The composition further comprises taurine or a hydrate or salt thereof.
Additional amino-acid deprivation beyond serine and glycine
The composition is further devoid of glutamine and salts thereof, and cysteine and salts thereof.
Magnesium and potassium source components
The composition further includes a Mg2+ source and a K+ source.
Across the provided claim content, the inventive concept is a unit dosage cancer-treatment amino-acid composition defined by glutamate, histidine, and isoleucine plus a pharmaceutically acceptable excipient, while being devoid of serine and glycine. The dependent refinements add taurine, additional amino-acid exclusions, and Mg2+ and K+ source components.
Stated Advantages
Reduced tumor cell proliferation or tumor volume versus placebo.
Modulation of serum amino acid levels.
Potential improvement in survival or progression-free survival.
Documented Applications
Personalized cancer treatment using amino-acid deprivation formulations.
Administration of sachet-based amino-acid formulations mixed into drinks.
Dietary co-intervention using modified diets that limit amino acids and adjust macronutrient and calorie sources, including low-protein diet and ketogenic-type diet.
Administration to healthy subjects and cancer patients with serum amino acid monitoring by LC-MS and tumor-related outcome comparisons versus placebo.
Cancer-related use cases referenced in the examples include pancreatic cancer, colorectal cancer, and breast cancer.
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