XENON

Pharmaceutical Grade Xenon

What is Xenon?

  • Xenon, a Greek word meaning “rare,” is one of six noble gases
  • Xenon (symbol: Xe) has been used in the Medical Community for diagnostic and treatment purposes for more than 60 years as an anesthetic

 

Landmark Discovery that Xenon is a potent N-Methyl-D-aspartic acid (NMDA) antagonist with neuroprotective properties – Franks, Nature, 1998

 

Xenon’s multiple mechanisms of action and synergy with therapeutic hypothermia, or targeted temperature management, have been demonstrated to protect against neurologic injury in preclinical models.³

  • Anti-Excitotoxicity – Anti-NMDA properties prevent excessive entry of calcium, a precursor to cell death early following several forms of acute neurological injury
  • Anti-Neuroapoptosis – Reduces expression of genes associated with programmed cell death (apoptosis) & increases anti-apoptotic proteins after neuronal injury
  • Cytotoprotective – Upregulates the reparative & restorative responses to oxygen deprivation even under normoxic conditions
  • Synergy with therapeutic hyperthermia, or cooling
  • Cardioprotective properties have been demonstrated in preclinical trials
  • Others
  • Clinical Evidence – Results from a Phase II Superiority Study published in JAMA in March 2016 showed statistically significantly less brain damage and directionally positive survival outcomes (though the study was not statistically powered to show such differences in this secondary endpoint) between a xenon plus cooling group versus a cooling-alone group.
    • Less Brain Damage: an MRI neuroimaging technique (Diffusion Tensor Imaging) to visualize location, orientation, & anisotropy (differences in diffusion) of brain’s white matter tracts revealed the following:
      • Over 50% less damage in the Xenon group was observed in context to those patients who survived or expired:
        • Fiber density (microintegrity), P = 0.006, of the white matter in the brain; and,
        • Nerve fiber protective covering in the brain (demyelination), P = 0.04
      • Overall, 41.7% of voxels of white matter tracts measured had less damage
      • Treatment effect size of xenon on the MRI biomarker was more than 50% of the difference in the measure observed between survivors and those who died
      • This MRI biomarker exhibited the best independent predictive value for mortality during the 6-month follow-up period
    • Improved Survival: The Phase II Study (N=110) was not statistically powered to show survival. However, a directionally positive absolute improvement in survival of 7.3% was observed in the intention-to-treat population, P = 0.053
      • A post-hoc analysis of patients with return of spontaneous circulation (ROSC) within 30 minutes, ~90% of all patients in the Study, revealed a statistically significant absolute improvement in survival of 12.3% (relative differences higher). This will serve as the basis for the patient inclusion criteria in the planned Phase III Study.
  • Non-toxic: no accumulation (elimination by exhalation); not metabolized

CLINICAL INFORMATION

Cardiac Arrest Program

Cardiac arrest (CA): abrupt loss of heart function, related to electrical system. Often precipitated by heart attack, related to blood flow blockage.

Prevalence:

  • 3rd leading cause of death (~1 CA/min in US)
  • ~570,000/yr in US, with 2/3 originating out-of-hospital Only

 

Prognosis:

  • <10% of CA patients survive to discharge
  • 75% of deaths occur from brain injury
  • 75% of survivors return to work

 

Pharmacological Therapy:

  • Therapeutic hypothermia is becoming the standard of care (AHA guidelines)
  • No treatment approved for neuroprotection post-CA

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