Niclosamide and Its Derivatives for Use in the Treatment of Solid Tumors

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This invention discloses new therapeutic applications of niclosamide and its derivatives, particularly in combination with alkylating agents like temozolomide, for the treatment of solid tumors such as glioblastoma. It highlights the effectiveness of niclosamide, especially for tumors with low expression or deletion of the NFKBIA gene. The patent also introduces diagnostic methods to determine if a cancer patient’s tumor will respond favorably to treatment with niclosamide alone or in combination with alkylating agents by assessing NFKBIA expression.

Use CasesContent extracted from patent full text and abstract with AI.

• Treatment of solid tumors, including glioblastoma, using niclosamide alone or in combination with alkylating chemotherapy agents (such as temozolomide).
• Personalized cancer therapy where patients are screened for NFKBIA expression to determine suitability and optimal dosing of niclosamide-based treatment.
• Application in other solid tumors with underexpression of NFKBIA, such as breast cancer, colorectal cancer, melanoma, hepatocellular carcinoma, and multiple myeloma.
• Use in both curative and palliative cancer therapy, including as pre-surgical (neoadjuvant) and post-surgical (adjuvant) therapy.
• Development of pharmaceutical formulations for central nervous system delivery, e.g., for brain tumors.
• Combination therapy regimens including niclosamide, alkylating agents, and possibly other cytostatic/cytotoxic drugs for maximum anti-tumor efficacy.

BenefitsContent extracted from patent full text and abstract with AI.

• Niclosamide, an existing approved antihelminthic drug, demonstrates potent and selective anti-cancer activity against a variety of solid tumors, especially glioblastoma.
• Combining niclosamide with alkylating agents offers synergistic effects, leading to greater tumor cell death and improved treatment outcomes.
• Personalized medicine approach enabled by testing for NFKBIA gene expression—therapy can be tailored to increase efficacy while reducing unnecessary exposure to drugs.
• The approach potentially overcomes resistance to alkylating agents in tumors with low NFKBIA, widening the pool of respondable patients.
• Pleiotropic action of niclosamide targets multiple cancer-driving signaling pathways, including Wnt/β-catenin, Notch, mTOR, and NF-κB, reducing chances of tumor escape via alternative mechanisms.
• Potential to reduce tumor-initiating/stem-like cells, decreasing recurrence risk.
• Niclosamide shows low toxicity to non-cancerous cells, suggesting a favorable side effect profile.

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Patent Abstract

The present invention relates to novel therapeutic uses of niclosamide for the treatment of cancer. In particular, a combination of niclosamide or one of its derivatives with an alkylating agent is provided for the treatment of solid tumors. Moreover, niclosamide or one of its derivatives can be used for the treatment of solid tumors characterized by underexpression of NFKBIA. Finally, the invention relates to diagnostic methods for determining whether treatment with niclosamide alone or in combination with an alkylating agent is suitable for a cancer patient.