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Publication Number
US-9351997-B2
Publication Date
2016-05-31
Expiration Date
Abstract
The invention provides a method for treating cancer using a coadministration strategy that combines local codelivery of a therapeutic agent and an intracellular penetration enhancing agent, and optionally in further combination with local administration of an immunotherapeutic agent, such as a cancer vaccine or NKT agonist. The invention also provides a method for treating cancer using an intracellular penetration enhancing agent. The methods of the invention aim to substantially kill and/or destroy the target tumor cells, as well as those cancerous cells that have metastasized to other parts of the body.
Core Innovation
The invention relates to a method of treating cancer in a subject in need of treatment by administering intratumorally an aqueous formulation that includes a therapeutically effective amount of a therapeutic agent and an intracellular permeation enhancing agent. The intracellular permeation enhancing agent is provided in combination with specific therapeutic agent selections in the aqueous formulation for intratumoral delivery.
The documented approach emphasizes using the intracellular permeation enhancing agent together with the therapeutic agent to achieve substantial tumor shrinkage or tumor eradication, including treatment of solid tumors such as carcinoma and sarcoma and treatment scenarios involving metastasis. In the disclosed concept, local/regional coadministration is used to support an effective anticancer outcome while maintaining the administration as intratumoral/intraregional.
The disclosure further describes that in some drug combinations, immune response activation can occur even without additional immunotherapy, and that local immunotherapy can be optionally followed by or combined with the intratumoral coadministration approach. Exemplary immunotherapeutic agents include cancer vaccines and NKT agonists, and illustrative immunotherapy examples include α-Gal glycolipids (α-GalCer) and β-mannosylceramide (β-ManCer).
Claims Coverage
The relevant independent claim is 1 inventive-feature combination: intratumoral administration of an aqueous formulation containing a specified therapeutic agent together with an intracellular permeation enhancing agent, where the enhancer is N-(8[2-hydroxybenzoyl]amino)octanoic acid and the therapeutic agent is cisplatin (with or without vinblastine) as specified in the claim.
Intratumoral aqueous formulation with intracellular permeation enhancing agent for cancer treatment
Administering intratumorally an aqueous formulation including a therapeutically effective amount of a therapeutic agent and an intracellular permeation enhancing agent.
Specific pairing of cisplatin with N-(8[2-hydroxybenzoyl]amino)octanoic acid
Wherein the formulation comprises cisplatin with N-(8[2-hydroxybenzoyl]amino)octanoic acid.
Specific pairing of vinblastine and cisplatin with N-(8[2-hydroxybenzoyl]amino)octanoic acid
Or cisplatin and vinblastine with N-(8[2-hydroxybenzoyl]amino)octanoic acid.
Across the independent claim, the core coverage is an intratumoral aqueous formulation for treating cancer that contains a therapeutically effective amount of a specified therapeutic agent combined with an intracellular permeation enhancing agent, specifically N-(8[2-hydroxybenzoyl]amino)octanoic acid paired with cisplatin and optionally with vinblastine.
Stated Advantages
Substantial tumor shrinkage and/or tumor eradication.
Potential immune response activation even without additional immunotherapy for certain drug combinations.
Prevention of tumor metastasis.
Potential reduced systemic toxicity.
Documented Applications
Treating cancer in a subject, including solid tumors such as carcinoma and sarcoma and treatment scenarios involving metastasis, by intratumoral administration of an aqueous formulation containing a therapeutic anticancer agent and an intracellular permeation enhancing agent.
Local immunotherapy can be followed by or combined with the intratumoral coadministration approach, including use of cancer vaccines and NKT agonists.
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