Protein product for treatment of infectious diseases and related inflammatory processes
Inventors
SARRIAS FORNES MARIA ROSA, null • Sarrias Fornés, Maria Rosa • Lozano Soto, Francisco
Assignees
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Publication Number
US-8691752-B2
Publication Date
2014-04-08
Expiration Date
Abstract
The inventors have found that CD6, a member of the Scavenger Receptor Cysteine-Rich (SRSR) superfamily expressed on human lymphocytes binds to Gram-positive and Gram-negative bacteria, as well as to other microbial structures. Thus, a CD6 product is useful for the manufacture of a medicament for therapeutic and/or preventive treatment of an infectious disease or of an inflammatory condition related to an infectious disease or to the presence of a product derived from an infectious agent in a mammal including a human. Examples of such inflammatory conditions are systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis and septic shock.
Core Innovation
The document describes CD6, including the Scavenger Receptor Cysteine-Rich (SRCR) ectodomain, and provides for recombinant or soluble forms of CD6. The CD6 products bind conserved microbial structures associated with infectious agents, including Gram-positive and Gram-negative bacteria and specific cell-wall components, in a Ca2+-dependent manner. The binding includes interactions with lipopolysaccharide (LPS), lipoteichoic acid (LTA), Re-LPS, peptidoglycan, and zymosan.
The document further reports that rsCD6 induces bacterial and LPS aggregation. In a mouse context, single-dose i.p. administration of rsCD6 prior to LPS challenge is reported to significantly improve survival and to reduce pro-inflammatory cytokines, including TNF-α, IL-1β, and IL-6.
Additionally, the document describes purification and characterization of natural soluble CD6 (nsCD6) from human serum, and it provides product definitions and a SEQ ID NO:1 embodiment. The overall disclosure characterizes CD6 as a therapeutic and/or preventive agent in infectious diseases and related inflammatory conditions, including SIRS, sepsis, severe sepsis, and septic shock.
Claims Coverage
The independent claim covers therapeutic and/or preventive treatment of sepsis in a mammal caused by Gram-positive and/or Gram-negative bacteria and/or endotoxins, using an effective amount of a CD6 product. The claim set includes additional dependent limitations that narrow the sepsis form and define particular CD6 product types and sequence content.
Therapeutic and/or preventive CD6 treatment of sepsis
A method for therapeutic and/or preventive treatment of sepsis in a mammal caused by a Gram-positive and/or Gram-negative bacterium and/or endotoxins, comprising administering to said mammal in need thereof an effective amount of a CD6 product.
Treatment of severe sepsis
The method of therapeutic and/or preventive treatment of sepsis is characterized such that the sepsis is severe sepsis.
Treatment of septic shock
The method is characterized such that the severe sepsis is septic shock.
Recombinant CD6 product
The method is characterized in that the CD6 product is a recombinant CD6.
CD6 product comprising SEQ ID NO:1
The CD6 product comprises the amino acid sequence SEQ ID NO: 1.
Treatment in a human mammal
The method is performed with the mammal being a human.
Across the independent claim and its dependents, the coverage focuses on administering a CD6 product—optionally recombinant and defined by SEQ ID NO:1—for therapeutic and/or preventive treatment of sepsis, with further narrowing to severe sepsis and septic shock and restriction to treatment in humans.
Stated Advantages
Improves survival in a mouse model when rsCD6 is administered prior to LPS challenge.
Reduces pro-inflammatory cytokines including TNF-α, IL-1β, and IL-6.
Documented Applications
Therapeutic and/or preventive treatment of sepsis in a mammal caused by Gram-positive and/or Gram-negative bacteria and/or endotoxins.
Treatment of SIRS, sepsis, severe sepsis, and septic shock (including endotoxin-associated forms as described).
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