Tuesday December 31, 2013

MONMOUTH JUNCTION, NJ--(Dec 31, 2013) - CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company working to control inflammation and save lives in the ICU through blood purification with its European Union approved CytoSorb® cytokine filter, provides an end-of-year update on its CytoSorb® Dosing study that is currently ongoing.

The CytoSorb® Dosing study ("Dosing study") is a multi-center trial being conducted amongst 8 leading clinical sites in Germany and is an extension of CytoSorbents' previous randomized controlled European Sepsis Trial (EST). The EST demonstrated CytoSorb® was a safe and effective broad spectrum cytokine filter, reducing cytokine storm and key cytokines by 30-50% in patients with septic shock and respiratory failure when used 6 hours a day for 7 days (See summary of the European Sepsis Trial). A post-hoc analysis of the EST clinical data also suggested that patients with either high cytokine levels or 65 years of age or older, benefitted the most from the therapy, including improvements in 28-day and 14-day survival, respectively.

The Dosing study was designed to evaluate the safety and preliminary efficacy of extended CytoSorb® treatment in septic patients with respiratory failure using the same inclusion and exclusion criteria as the EST. The major goals of the study were to:

  • Obtain safety data on extended CytoSorb® treatment
  • Confirm CytoSorb® cytokine removal over an extended period of usage
  • Provide clinicians with more flexibility on how to treat critically ill patients with CytoSorb®
  • Obtain data to help optimize treatment and support the design of a US pivotal sepsis trial to prove effectiveness. This Dosing study was not intended to produce statistically significant data on clinical endpoints.


There are two CytoSorb® treatment protocols being evaluated in the Dosing study: 1) 24 hours per day for 7 days and 2) 6 hours per day for up to 14 days, each day using a new device. Currently, only the 24-hour treatment arm is enrolling patients. The intent is to compare these two arms against clinical outcomes from control and treated patients in the EST (6 hours a day for 7 days) using a matched pairs analysis strategy. In this analysis, all patients in the Dosing study are treated with CytoSorb®, and then are later matched and compared to patients from the EST trial using variables in common such as age