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Details

Project TitleBiologic Treatment for Sepsis
Track CodeL-BIO-AH-007
Short DescriptionA multi-faceted protein with potent anti-inflammatory, anti-apoptotic and anti-coagulant effects, that significantly reduces myocardial TNF-α production and IL-β production during sepsis.
AbstractNone
 
Tagsanti-apoptotic, anti-coagulant, anti-inflammatory, cardiovascular, health, health & life sciences, infection, infectious disease, inflammation, lifesciences, medical sciences, sepsis, therapeutic intervention, therapy
 
Posted DateApr 14, 2010 11:17 AM

Description

This biologic is a multi-faceted protein with potent anti-inflammatory, anti-apoptotic and anti-coagulant effects. Our scientists have discovered that it significantly reduces myocardial TNF-α production and IL-β production during sepsis resulting in significant improvement in cardiac function and survival in clinically relevant animal models of sepsis. They have also discovered a novel interaction of the biologic with Toll-like receptor 4 (TLR4) that may compete with bacterial endotoxin for binding to TLR4 to initiate sepsis.

Background

Sepsis is a complex clinical syndrome resulting from a harmful host response to infection characterized by the production of tumor necrosis factor–α (TNF-α), a pro-inflammatory cytokine, which has been shown to be one of the main mediators of cardiovascular dysfunction. Cardiovascular dysfunction is common in patients with sepsis and contributes to the development of multi-organ failure associated with an extremely high mortality of ~50%. Sepsis is one of the leading causes of death globally and yet there is currently only one approved therapeutic product on the market that demonstrated a minor improvement in the absolute reduction of mortality only in severe sepsis patients limiting its indication to this patient population, and it is contraindicated in many patients due to potentially serious side-effects including severe bleeding (Bernard et. al. 2001. NEJM. 344: 699-709; Abraham et. al. 2005. NEJM. 353: 1332-1341). Furthermore, to date none of the very few alternatives in clinical development have demonstrated substantial promise in advanced trials. The failure of many drugs for sepsis therapy may be due to a single mode of action for a complex syndrome. New drugs with minimal side-effects that are able to intervene at multiple points in the sepsis cascade to decrease mortality are desperately needed. The global market for an effective and safe sepsis treatment is estimated to be over $8 billion annually.

Advantages

  • A novel prophylactic and therapeutic treatment for sepsis that improves cardiac function and reduces mortality
  • Significantly reduces myocardial TNF-α and IL- β production during sepsis
  • Interacts directly with TLR4 receptors and may inhibit TLR4-mediated sepsis initiation/escalation by bacterial endotoxin
  • A multi-faceted therapeutic protein with potent anti-inflammatory, anti-apoptotic, and anti-coagulant effects
  • Anti-coagulant activity is mild and not expected to generate bleeding related side-effects
  • May improve the function of other organs in sepsis and have therapeutic potential for other inflammatory conditions
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