Methods of treating a subject for pain

Inventors

Castro, Marian • Gallager, Ian • Kheifets, Viktoria

Assignees

Alkahest Inc

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Publication Number

US-11547724-B2

Patent

Publication Date

2023-01-10

Expiration Date


Abstract

The disclosure pertains to methods of treating pain. In certain embodiments, the methods comprise administering to a subject a Plasma Protein Fraction (PPF) in an amount that is effective to treat pain.

Core Innovation

The invention relates to a method of treating pain in a subject diagnosed with pain by administering an effective amount of a Plasma Fraction. The Plasma Fraction is presented as a plasma protein fraction derived from human plasma, including embodiments defined by purity and compositional components. The described approach positions plasma fractions as therapeutic compositions for treating pain and related recovery outcomes.

The patent frames the problem as the need for treating pain conditions, including chronic/neuropathic pain and post-CCI pain, with compositions derived from human plasma protein fractions. The disclosed treatment is supported by in vivo evidence in chronic constrictive injury (CCI) mouse models, using mechanical von Frey and hot plate assessments to evaluate pain-related outcomes. Comparisons are made versus vehicle and gabapentin, and against recombinant human albumin.

Mechanistic readouts disclosed in the document include neurogenesis via doublecortin (DCX), reduced neuroinflammation indicated by CD68, reduced spinal BDNF, and increased myelination markers MBP and S-100. In addition to pain treatment, plasma protein fractions are also described in contexts of wound healing and accelerating recovery, including diabetic and ob/ob wound models, where reduced wound closure time and improved histology are reported.

Claims Coverage

The document provides one independent claim that broadly covers treating a subject diagnosed with pain by administering an effective amount of a Plasma Fraction. Dependent claim refinements add specific pain subtypes, define the Plasma Fraction as a plasma protein fraction, and further narrow composition and dosing regimen features, including an albumin percentage range and a Pulse Dose dosing regimen.

Treating a diagnosed pain subject with an effective amount of a plasma fraction

Administering an effective amount of a Plasma Fraction to a subject diagnosed with pain to treat the subject for pain.

Plasma fraction is a plasma protein fraction

The Plasma Fraction is a Plasma Protein Fraction.

Plasma protein fraction comprises albumin between 83% and 95%

The plasma protein fraction includes between 83% and 95% albumin.

Pulse dose dosing regimen

Administering the treatment using a Pulse Dose dosing regimen.

Overall, the claim coverage is centered on administering an effective amount of a plasma fraction for pain, with specific dependent refinements defining the fraction as a plasma protein fraction, adding an albumin content range, and limiting administration to a Pulse Dose dosing regimen. Additional dependent limitations specify pain as chronic and/or peripheral pain.

Stated Advantages

Treats pain in a subject diagnosed with pain.

Improves pain-related outcomes in CCI models as assessed by mechanical von Frey and hot plate testing.

Reduces neuroinflammation as indicated by CD68.

Reduces spinal BDNF.

Increases myelination markers MBP and S-100.

Supports neurogenesis as indicated by doublecortin (DCX).

Accelerates recovery and improves wound healing in diabetic and ob/ob wound models, including reduced wound closure time and improved histology.

Documented Applications

Treatment of chronic/neuropathic and post-CCI pain using plasma protein fractions derived from human plasma.

Wound healing and accelerating recovery using plasma protein fractions, including diabetic and ob/ob wound models with reduced wound closure time and improved histology.

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