Treatment of disease using inter-alpha inhibitor proteins
Inventors
Lim, Yow-Pin • Stonestreet, Barbara
Assignees
Women and Infants Hospital of Rhode Island • Prothera Biologics Inc
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Publication Number
US-9572872-B2
Publication Date
2017-02-21
Expiration Date
Abstract
The invention relates to methods of treatment of medical conditions (e.g., diseases and injuries) in a mammal (e.g., a human), such as hypoxia/ischemia, burns, and viral infections (e.g., influenza, West Nile virus, and Dengue fever), in adults and in children (e.g., neonates) by administering a composition that includes an IAIP.
Core Innovation
The invention relates to administering inter-alpha inhibitor (IαI) and/or pre-alpha inhibitor (PαI) proteins to treat, reduce, or inhibit ischemia or a condition resulting from ischemia in a patient having ischemia. The ischemia-related treatment covers ischemia/reperfusion injury and hypoxic ischemia, and includes hypoxic ischemia encephalopathy and cerebral palsy.
Administration of IAIPs is associated with changes in biological markers and inflammatory mediators in the context of ischemia. The documented effects include decreases in cytokines, including IL-1β, TNF-α, IL-6, and IL-10, as well as modulation of TNF-α and reduction of free radicals and related injury pathology.
The document also describes IAIP use beyond ischemia, including treatment of wounds and prevention or treatment of viral infections, including influenza, West Nile, and Dengue, and cancer metastasis as additional aspects. In wound treatment, the document states administering a composition comprising inter-alpha inhibitor (IαI) and/or pre-alpha inhibitor (PαI) proteins, including topical administration for burn treatment.
Claims Coverage
The document includes two independent claims: one directed to treating ischemia and one directed to treating a wound. Across these independent claims, the main inventive features are IAIP protein administration for the respective target condition, with claim coverage further refined by ischemia subtype, affected mediators such as cytokines, TNF-α, and free radicals, and wound type, formulation, and administration details such as topical delivery and carrier composition.
Administering IAIP proteins to treat ischemia
A method of treating, reducing, or inhibiting ischemia or a condition resulting from ischemia in a patient having ischemia comprising administering to said patient a composition comprising inter-alpha inhibitor (IαI) and/or pre-alpha inhibitor (PαI).
Administering IAIP proteins to treat a wound
A method of treating a wound in a patient in need thereof, said method comprising administering to said patient a composition comprising inter-alpha inhibitor (IαI) and/or pre-alpha inhibitor (PαI) proteins.
Treating specific ischemia subtypes
The ischemia is one of ischemia/reperfusion injury, hypoxic ischemia, acute ischemia, or persistent ischemia.
Decreasing cytokines after IAIP administration
Administration of the composition decreases or down-regulates one or more cytokines.
Cytokine categories affected
The cytokines are selected from pro-inflammatory cytokines, intravascular cytokines, and/or endothelial-derived cytokines.
Reducing free radicals and TNF-α
Administration results in a decrease in free radicals and/or a decrease in TNF-α.
Administering IAIP compositions via multiple routes
The composition is formulated for administration via inhalation, insufflation, nebulization, injection, oral, rectal, topical, intraperitoneal administration, intracerebral injection, intravenous delivery, or fetal infusion.
Treating burns as a wound indication
The wound treated is a burn.
Topical wound treatment
The pharmaceutical composition is administered topically.
Suspending or dissolving in a carrier
The pharmaceutical composition is suspended or dissolved in a carrier.
Carrier materials for topical delivery
The carrier comprises polyethylene glycol or sodium carboxymethylcellulose.
Claim coverage centers on administering inter-alpha inhibitor (IαI) and/or pre-alpha inhibitor (PαI) proteins. For ischemia, the document further specifies effects on cytokines, TNF-α, and free radicals, and covers multiple ischemia subtypes and administration routes. For wound treatment, the document specifies burn treatment with topical administration and a carrier comprising polyethylene glycol or sodium carboxymethylcellulose.
Stated Advantages
Decreases or down-regulates one or more cytokines.
Decreases free radicals and/or decreases TNF-α.
Treating, reducing, or inhibiting ischemia or a condition resulting from ischemia.
Treating a wound, including treatment of a burn.
Documented Applications
Treating, reducing, or inhibiting ischemia or a condition resulting from ischemia in a patient having ischemia, including ischemia/reperfusion injury and hypoxic ischemia.
Treatment of hypoxic ischemia encephalopathy and cerebral palsy as ischemia-associated conditions.
Treating a wound, including treating a burn.
Prevention or treatment of viral infections, including influenza, West Nile, and Dengue.
Cancer metastasis as an additional aspect.
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