Have you ever heard of the word ‘Sepsis’? This is a disease commonly reported from US hospitals but its awareness is very low. It is a leading cause of mortality in US affecting 750,000 patients and causing death in 250,000 every year.
The two forms of sepsis with a combined mortality rate of 30-35% are ‘Severe Sepsis’ and ‘Septic Shock’. Surprisingly, there is not a single FDA-approved drug still available to treat this disease. Eli Lilly withdrew its drug ‘Xigris’ from US market in early 2011 due to efficacy and safety issues.
Another drug ‘Eritorin’ failed efficacy test in phase-III trials and ‘Talactoferrin’ failed safety teats in phase-II and III trials. Researchers from US and Canada are currently participating in “EUPHRATES’, a late-stage North American Multi-Center clinical study to evaluate if a combination of therapeutic and diagnostic (theranostic) techniques can improve the rate of survival of patients.
This study relies on diagnosis and treatment using personalized medicines and targets a specific sub-group of patients’ with highest mortality risk. Earlier studies suggested that endotoxemia’ caused by elevated levels of ‘endotoxin’ in the blood could be a potential trigger of sepsis causing a physiological chain of events leading to organ failures and eventually death.
Recent studies showed that almost one half of the patients’ diagnosed with sepsis had endotoxemia. The theranostic substance in EUPHRATES study consists ‘Endotoxin Activity Assay TM-EAA and Toraymyxin TM. EAA TM is a rapid diagnostic cleared by FDA to measure endotoxin levels in the blood. Toraymyxin TM is a therapeutic hemoperfuison device which removes endotoxin from blood.
These are approved in 18 countries and have been used to treat almost 80 patients’ safely. In US, Toraymyxin is still regarded as an investigational device. When used along with conventional therapy, it reduced 28-days mortality rates in patients substantially as compared to patients who received only conventional therapy.
If EUPHRATES trials become successful, there could be a sea change in the manner in which patients get treated for sepsis and this first effective treatment would bring about a major break-through in the area of unmet medical need.
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