The liver controls or affects almost every aspect of metabolism and most physiologic regulatory processes in the human body. Global loss of liver function is therefore lethal.  Acute liver failure affects all age groups and may be caused by viruses, ingestion of common analgesic medications, alcohol, ischemic insult and extensive liver resection for trauma or cancer.  It may develop in the absence of preceding liver disease or as an acute exacerbation of a chronic underlying condition.  The majority of patients from the first group will die, unless they undergo liver transplantation; only a small percentage of these patients will recover and subsequently have normal liver function.  The second group of patients will often respond to treatment of the precipitating cause of the acute exacerbation; if therapy is not effective or the extent of liver destruction irreparable, they can succumb due to sepsis, hemorrhage and development of multiple organ failure.

Liver failure represents a large, untapped market opportunity and a grave medical condition.  An estimated 10-20 million hospitalizable episodes of liver failure occur worldwide each year, with more than one million occurring in North America and Europe.  Mortality rates for patients with liver failure are unacceptably high, reaching 90% in certain segments of the patient population, and resulting in 1-2 million deaths worldwide per year.  

The current standard of care for liver failure involves administration of intravenous fluid, antibiotics and blood products.  However, no direct pharmaceutical therapies currently exist.  The most reliably curative therapy is liver transplantation, which is costly, limited by the number of available organs and unavailable to a large majority of patients.