Fractionated radiotherapy and chemotherapy with an oxygen therapeutic

Inventors

Unger, Evan C.

Assignees

Nuvox Pharma LLC

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Publication Number

US-11534492-B2

Patent

Publication Date

2022-12-27

Expiration Date


Abstract

A fluorocarbon emulsion in water for use in fractionated radiotherapy and chemotherapy, wherein said fluorocarbon comprises between 4 and 8 carbon atoms.

Core Innovation

The invention provides a method of treating solid hypoxic tumors by multi-fraction radiotherapy. The method includes administering to a subject suffering from a solid hypoxic tumor a water emulsion of perfluoropentane to the mammal, concomitantly or up to 120 minutes prior to each fraction of radiation therapy.

The perfluoropentane emulsion is a water emulsion comprising a viscosity modifier, a fluorosurfactant, and about 1% to 10% w/vol of perfluoropentane. The solid hypoxic tumor is selected from pancreatic cancer, non-small cell lung cancer, cervical carcinoma, squamous cell carcinoma, ovarian cancer, sarcoma, multiple myeloma, prostate cancer, rectal cancer, Wilms tumor, head and neck cancer, oral carcinoma and uterine carcinoma.

The document also describes oxygen therapeutic delivery using fluorocarbon emulsion formulations with lower-boiling fluorocarbons, with testing in fractionated radiotherapy, and optional use together with chemotherapy. The rationale relates to improved tumor re-oxygenation relative to room air approaches and multi-dose fractionated-treatment settings, supported by examples and gene-expression normalization claims.

Claims Coverage

The patent includes one independent claim directed to a treatment method using a perfluoropentane water emulsion administered with multi-fraction radiotherapy within a specified timing window. The claim coverage includes dependent refinements that specify emulsion components, concentration limits, administration format, and the addition of co-administered anticancer agents, as well as tumor-type selection.

Multi-fraction radiotherapy with perfluoropentane emulsion dosing window

A method of treating solid hypoxic tumors by multi-fraction radiotherapy, comprising administering to a subject suffering from a solid hypoxic tumor a water emulsion of perfluoropentane concomitantly or up to 120 minutes prior to each fraction of radiation therapy.

Water emulsion composition with viscosity modifier, fluorosurfactant, and perfluoropentane content

The water emulsion of perfluoropentane comprises a viscosity modifier, a fluorosurfactant, and about 1% to 10% w/vol of perfluoropentane.

Solid hypoxic tumor type selection

The solid hypoxic tumor is selected from pancreatic cancer, non-small cell lung cancer, cervical carcinoma, squamous cell carcinoma, ovarian cancer, sarcoma, multiple myeloma, prostate cancer, rectal cancer, Wilms tumor, head and neck cancer, oral carcinoma and uterine carcinoma.

Constrained perfluoropentane emulsion concentration

The perfluoropentane emulsion includes about 1% to 5% w/vol perfluoropentane.

PEG Telomer B fluorosurfactant concentration constraint

The fluorosurfactant PEG Telomer B is present at about 3 mg/mL.

Sucrose viscosity modifier concentration constraint

The sucrose concentration is about 300 mg/mL.

Intravenous infusion administration duration constraint

The perfluoropentane emulsion is administered as an intravenous infusion for up to 30 minutes.

Co-administration with an anticancer agent

The perfluoropentane emulsion is co-administered with an anticancer agent.

Overall, the claim set focuses on treating selected solid hypoxic tumors with multi-fraction radiotherapy using a perfluoropentane water emulsion administered concomitantly or within 120 minutes of each radiation fraction. The dependent claim refinements further define the emulsion components and constrain perfluoropentane content, fluorosurfactant and viscosity modifier concentrations, an IV infusion timing limitation, and co-administration with an anticancer agent.

Stated Advantages

Improved tumor re-oxygenation versus room air approaches.

Documented Applications

Fractionated radiotherapy treatment of solid hypoxic tumors using a perfluoropentane water emulsion oxygen therapeutic.

Optional combination with chemotherapy in fractionated radiotherapy settings.

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