Use of S-adenosylmethionine, vitamin E, and vitamin C for the treatment of oxidative liver injury

Inventors

Lautt, Wilfred WayneMing, Zhi

Assignees

University of ManitobaScimar Ltd

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Publication Number

US-8716260-B2

Patent

Publication Date

2014-05-06

Expiration Date


Abstract

The present invention provides antioxidant compositions comprising S-adenosylmethionine (SAMe), vitamin E and vitamin C and uses thereof for the treatment of liver injury and insulin resistance.

Core Innovation

The invention relates to treating oxidative liver injury by administering, to a patient in need thereof, S-adenosylmethionine (SAMe) together with vitamin E and vitamin C. The document describes this as a combination therapy and frames it as applicable to oxidative liver injury in acute and chronic settings. It further addresses insulin resistance associated with oxidative liver injury, including HISS-dependent insulin resistance.

The document provides a mechanistic rationale for the combination therapy. Vitamin C is described as quenching aqueous radicals, while vitamin E is described as inhibiting lipid peroxidation. SAMe is described as restoring glutathione, collectively targeting reactive oxygen species (ROS) and nitrogen species (RNS) in the context of oxidative liver injury.

The document supports the combination therapy with a rat acute liver injury study using a thioacetamide (TAA) model and assessment by the rapid insulin sensitivity test (RIST). The combined SAMe plus vitamins C/E is described as improving the RIST index, including the HISS-dependent component. The combination therapy is further described as partially preventing elevations in ALT/AST and markedly reducing histopathological injury versus SAMe alone or vitamins C+E alone.

Claims Coverage

The partial document identifies three independent claims: one method claim and two kit claims. Across these independent claims, the inventive coverage is centered on a defined combination of SAMe (or derivatives/salts) with vitamin E (or derivatives/salts) and vitamin C (or derivatives/salts) for treating oxidative liver injury, including instructions for use in the kit forms.

Treating oxidative liver injury with SAMe plus vitamin E and vitamin C

A method of treating oxidative liver injury comprising administering a therapeutically effective amount of S-adenosylmethionine (or a derivative or pharmaceutically acceptable salt), vitamin E (or a derivative or pharmaceutically acceptable salt), and vitamin C (or a derivative or pharmaceutically acceptable salt) to a patient in need thereof.

Kit with composition for oxidative liver injury treatment

A kit comprising a composition comprising S-adenosylmethionine (or a derivative or pharmaceutically acceptable salt), vitamin E (or a derivative or pharmaceutically acceptable salt) and vitamin C (or a derivative or pharmaceutically acceptable salt), and instructions for use of said composition in the treatment of oxidative liver injury.

Kit with individual dosage units for oxidative liver injury treatment

A kit comprising individual dosage units of S-adenosylmethionine (or a derivative or pharmaceutically acceptable salt), vitamin E (or a derivative or pharmaceutically acceptable salt) and vitamin C (or a derivative or pharmaceutically acceptable salt), and instructions for use of said dosage units in the treatment of oxidative liver injury.

Overall, the independent claim set covers both a treatment method and corresponding kit formats that include a specific SAMe/vitamin E/vitamin C combination (including derivatives or pharmaceutically acceptable salts) intended for treating oxidative liver injury, with the kit claims additionally requiring instructions for use.

Stated Advantages

Improves the RIST index, including the HISS-dependent component.

Partially prevents elevations in ALT/AST.

Markedly reduces histopathological injury versus SAMe alone or vitamins C+E alone.

Documented Applications

Treatment of oxidative liver injury, described as acute and chronic.

Addressing insulin resistance associated with oxidative liver injury, including HISS-dependent insulin resistance, in connection with RIST assessment.

Use of the combination therapy in a rat acute liver injury study using a thioacetamide (TAA) model and evaluation by RIST and histopathology.

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