Cancer therapy

Inventors

BENT, Rebecca Lambert

Assignees

NED Biosystems Inc

Abstract

The present invention is directed to compositions and methods for the treatment of cancers, particularly cancers of epithelial origin. Therapy with a plurality of nutraceutical, non-chemotherapeutic and chemotherapeutic agents, that together target a plurality of cancer-supportive processes in a patient are disclosed. Among other things, the present invention encompasses the insight that redundant targeting of multiple such pathways provides effective treatment of various cancer, including late-stage cancers, metastasized cancers, and/or cancers that have failed treatment with traditional chemotherapy and/or other therapeutic modalities.

Core Innovation

The patent text describes an integrative cancer therapy for cancers of epithelial origin, with emphasis on late-stage cancers at least stage II. The approach is based on orally administered combinations of at least seven agents that include metronomic low-dose chemotherapy combined with nutraceutical or non-chemotherapeutic agents. The therapy is intended to redundantly target multiple cancer-supportive processes in parallel, including angiogenesis and vasculogenesis, apoptosis dysregulation, metabolic processes associated with the Warburg effect, intracellular and intercellular signaling, and immune surveillance.

The background rationale emphasizes that metronomic dosing is used at chronic dosing levels below maximum tolerated dose, with regimen selection supported by personalized tailoring using blood and tissue pathway marker analysis. The described multi-component strategy is directed to address angiogenesis and vasculogenesis mechanisms, including vasculogenic mimicry, and anti-angiogenic regulators such as VEGF, MMP-2, MMP-9, TNF-α, and TGF-β. It also references signaling and cell-cycle related pathway components including EGFR, IL-6, p53/p21, BCL-2 family, NF-κB, and cell cycle arrest.

The document further links the therapy to additional hallmark pathway targets including the Warburg effect and aerobic glycolysis, oxidative stress, mTOR and PI3K/AKT/mTOR signaling, RAS/RAF/MEK/ERK signaling, HEDGEHOG, HIF-1α, and immune surveillance components such as Treg cells, NK cells, and CTL. The therapy is exemplified as specific oral regimens that combine metronomic cyclophosphamide with nutraceuticals including metformin, alpha-lipoic acid, curcumin, genistein, melatonin, and low-dose naltrexone, with example regimens also provided for late-stage cancer treatment contexts.

Claims Coverage

The partial content provides two independent claims: one directed to a method of treating late-stage ovarian cancer using orally administered at least seven agents, and one directed to a combination composition comprising the specified orally dosed agents. Across these claims, the inventive features focus on the oral multi-agent regimen and specific dosing constraints for multiple named components.

The claim set in the partial content centers on an orally administered multi-agent regimen that combines metronomic low-dose cyclophosphamide with specific nutraceutical and non-chemotherapeutic agents and imposes defined dose constraints for multiple components. The method claim applies this combination to late-stage ovarian cancer at least stage II, and dependent claim elements further refine use to metastatic, terminal, or relapsed ovarian cancer contexts and non-maximum-tolerated-dose constraints.

Stated Advantages

Documented Applications