Methods of using microspheres for active embolization

Inventors

Vogel, Jean-Marie • Boschetti, Egisto

Assignees

Biosphere Medical Inc

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Publication Number

US-8697137-B2

Patent

Publication Date

2014-04-15

Expiration Date


Abstract

The present invention relates to injectable compositions comprising biocompatible, swellable, substantially hydrophilic, non-toxic and substantially spherical polymeric material carriers which are capable of efficiently delivering bioactive therapeutic factor(s) for use in embolization drug therapy. The present invention further relates to methods of embolization gene therapy, particularly for the treatment of angiogenic and non-angiogenic-dependent diseases, using the injectable compositions.

Core Innovation

The invention provides a method for the treatment of a solid tumor by active embolization by administering to a patient a microsphere that includes a biocompatible sodium acrylate and vinyl alcohol copolymer. The microsphere is associated with doxorubicin, and doxorubicin is released at the site of the tumor.

The disclosed microsphere platform is directed to active embolization together with delivery of a bioactive therapeutic factor, where the microsphere is configured to release the associated therapeutic at the tumor site. The microspheres are described in association with tumor treatment contexts, including solid tumors and hepatic tumors.

The patent further characterizes the microsphere formulation as injectable swellable substantially hydrophilic polymeric microspheres. It emphasizes local tumor-site activity through microsphere swellability and release behavior, and includes examples of therapeutic and diagnostic or labeling components associated with the microspheres.

Claims Coverage

The independent claim family portion provided centers on active embolization treatment of solid tumors using doxorubicin-associated microspheres made from a biocompatible sodium acrylate and vinyl alcohol copolymer, with tumor-site release of doxorubicin. The disclosed dependent refinements add microsphere physical parameters, partial occlusion of blood flow, drug coating and loading behavior, and hepatic tumor selection.

Active embolization microsphere for solid tumor treatment with doxorubicin release

A method for the treatment of a solid tumor by active embolization comprising administering to a patient having the solid tumor a microsphere comprising a biocompatible sodium acrylate and vinyl alcohol copolymer, the microsphere being associated with doxorubicin, wherein doxorubicin is released at the site of the tumor.

Biocompatible sodium acrylate and vinyl alcohol copolymer microsphere carrier

The microsphere comprises a biocompatible sodium acrylate and vinyl alcohol copolymer as the carrier used for active embolization and association with doxorubicin.

Doxorubicin-associated microspheres configured for tumor-site release

The doxorubicin is associated with the microsphere and is released at the site of the tumor.

Injectable microsphere diameter range

The microsphere has a diameter ranging from about 10 μm to about 2000 μm.

Microsphere swellability magnitude

The microspheres swell to about 15 times their original size.

Partial occlusion of blood flow to the tumor

A treatment includes administering an embolization that partially occludes blood flow to the tumor.

Drug coating and maintaining high loading until release

A drug is coated on microspheres and is kept on their surface in an amount selected from specified greater-than percentages (or about 100%) until the drug is released.

Hepatic tumor subtype specification

The hepatic tumor is a hepatocellular carcinoma.

Overall, the claim coverage emphasizes solid tumor active embolization using a biocompatible sodium acrylate and vinyl alcohol copolymer microsphere associated with doxorubicin, with tumor-site release. The dependent refinements further specify microsphere size and swellability, partial occlusion of blood flow, drug coating and high loading release behavior, and tumor-type selection for hepatic tumors.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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