CytoSorbents Provides Clinical Update on CytoSorb Dosing Study

CytoSorbents Provides Clinical Update on CytoSorb Dosing Study 
MONMOUTH JUNCTION, NJ -- (Marketwired) -- 12/31/13 --  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(R)
cytokine filter, provides an end-of-year update on its CytoSorb(R)
Dosing study that is currently ongoing.  
The CytoSorb(R) 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(R) 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(R) 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(R) treatment
    
    
--  Confirm CytoSorb(R) cytokine removal over an extended period of
    usage
    
    
--  Provide clinicians with more flexibility on how to treat critically
    ill patients with CytoSorb(R)
    
    
--  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(R) 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(R), and then are later matched and compared
to patients from the EST trial using variables in common such as age
≥ 65 years old, need for dialysis, APACHE 2 score, cytokines,
and other factors.   
There have been 28 patients enrolled into the first arm (24 hours of
treatment for 7 days) of the trial to date. Preliminary analysis of
the available data suggest the following:  


 
--  CytoSorb(R) treatment is well tolerated at flow rates up to 300
    mL/min, with no serious device related adverse events in the trial to
    date. 24-hour treatment increases platelet reduction compared to
    6-hour treatment in the EST, but with no reported complications.
    
    
--  CytoSorb(R) is compatible with a variety of antibiotics including
    aminoglycosides and broad-spectrum antibiotics, such as the carbepenem
    class, which require only modest dose adjustments. Additional
    antibiotic testing is underway.
    
    
--  CytoSorb(R) is concentration dependent and continues to actively
    remove IL-6 during the entire 24-hour treatment period, higher at the
    beginning of treatment when IL-6 levels are highest, and with an
    overall average instantaneous IL-6 reduction of 8% per pass. For each
    patient, approximately 60-70 total blood volumes, the equivalent of
    approximately 300 liters or 75 gallons of blood, are treated per day.
    In an in vitro blood perfusion system with no cytokine production,
    this equates to a rapid and greater than 99% reduction of IL-6. In the
    body, however, with active ongoing cytokine production, the overall
    reduction is less.
    
    
--  Safety data obtained from this study on continuous 24-hour treatment
    will be used to provide additional examples in the "Instructions for
    Use" document that accompanies the product for commercial usage. This
    will provide additional flexibility in how physicians use
    CytoSorb(R) in sepsis and other critical care applications.
    
    
--  The first treatment arm continues to enroll patients. In this
    preliminary analysis, the overall 28-day all-cause mortality and
    28-day all-cause mortality in patients 65 years and older is
    statistically similar to the treatment data reported in the EST
    (electronic randomized cohort). Severity of illness in the overall
    treatment groups were comparably high, with 50% or more of the treated
    patients (dosing > EST) having an APACHE 2 severity of illness score >
    25 at the time of enrollment, predicting very high mortality of 55% or
    more. In comparison, the overall control patients reported in the EST
    (electronic randomization cohort) had a lower severity of illness with
    only 20% having an APACHE 2 score > 25.
    
    
--  Cytokine analysis and matched pairs analysis is currently ongoing, and
    60-day mortality data is still pending on many recently enrolled
    patients.

  
Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents, stated, "We are pleased
that 24-hour treatment with CytoSorb(R) has been safe and easy to
implement to date, and that it demonstrates robust continuous
cytokine removal across the entire treatment period as expected. We
are also encouraged that the first arm of the Dosing study has
already treated more patients than in the reported data from the EST,
and that we are seeing similar trends in a very heterogenous,
critically ill patient population. This first arm of the trial has
generated many interesting insights that will help to modify the
second arm of the trial."  
Dr. Chan continued, "Our understanding of how to use CytoSorb(R) to
treat severe sepsis and septic shock, and other critical illnesses
continues to advance. This dosing study, nearly 30 post-market
investigator initiated studies either starting or being planned,
multiple case report studies, and the establishment of an
international treatment registry, are part of a much larger plan to
generate a significant amount of clinical data in coming months to
years that will help physicians optimally treat their patients with
CytoSorb(R)." 
About CytoSorbents Corporation  
CytoSorbents is a critical care focused immunotherapy company using
blood purification to modulate inflammation -- with the goal of
preventing or treating multiple organ failure in life-threatening
illnesses. Organ failure is the cause of nearly half of all deaths in
the intensive care unit, with little to improve clinical outcome.
CytoSorb(R), the Company's flagship product, is approved in the
European Union as a safe and effective extracorporeal cytokine
filter, designed to reduce the "cytokine storm" that could otherwise
cause massive inflammation, organ failure and death in common
critical illnesses such as sepsis, burn injury, trauma, lung injury,
and pancreatitis. These are conditions where the mortality is
extremely high, yet no effective treatments exist. CytoSorbents'
purification technologies are based on biocompatible, highly porous
polymer beads that can actively remove toxic substances from blood
and other bodily fluids by pore capture and surface adsorption.
CytoSorbents has numerous products under development based upon this
unique blood purification technology, protected by 32 issued US
patents and multiple applications pending, including HemoDefend(TM),
ContrastSorb, DrugSorb, and others. Additional information is
available for download on the Company's website:
http://www.cytosorbents.com.  
Forward-Looking Statements  
This press release includes forward-looking statements intended to
qualify for the safe harbor from liability established by the Private
Securities Litigation Reform Act of 1995. Forward-looking statements
in this press release are not promises or guarantees and are subject
to risks and uncertainties that could cause our actual results to
differ materially from those anticipated. These statements are based
on management's current expectations and assumptions and are
naturally subject to uncertainty and changes in circumstances. We
caution you not to place undue reliance upon any such forward-looking
statements. Actual results may differ materially from those expressed
or implied by the statements herein. Risk factors are detailed in the
Company's Form 10-K filed with the SEC on April 3, 2013, which is
available at http://www.sec.gov.  
Company Contact: 
CytoSorbents Corporation
Dr. Phillip Chan
Chief Executive Officer 
(732) 329-8885 ext. *823
pchan@cytosorbents.com