MONMOUTH JUNCTION, NJ--(Marketwired - Aug 21, 2013) - CytoSorbents Corporation (
The following institutions join University of Goettingen, Helios Erfurt, and University of Aachen in the trial:
- University of Jena
- University of Hamburg - Eppendorf
- University of Greifswald
- University of Leipzig
- University of Oldenburg
With the last site expected to be initiated shortly, all of these new clinical sites have been initiated to begin new patient enrollment, which is expected to significantly accelerate the completion of the trial, with the intent of having at least interim data by the end of the year.
The matched-pairs dosing study was designed to evaluate the safety and preliminary efficacy of extended CytoSorb® treatment, in order to give physicians more flexibility on how to treat critically ill patients with CytoSorb®. The two treatment arms of the study include 24 hours of treatment, each day for 7 days (ongoing), and 6 hours of treatment, each day for up to 14 days or until clinical improvement (planned). In addition, the study is intended to support the design of a pivotal trial protocol in the United States. This pivotal study in sepsis is expected to start in 2014, pending successful discussions with the FDA, with the goal of definitively demonstrating the effectiveness of CytoSorb® for the treatment of sepsis, and to seek U.S. regulatory approval. The FDA has already approved an investigational device exemption (IDE) application to run a small CytoSorb® sepsis trial in the U.S. and has recently reviewed the human safety data on CytoSorb® from the European Sepsis Trial in approving the U.S. Air Force funded trauma and rhabdomyolysis trial using CytoSorb®.
Dr. Robert Bartlett, Chief Medical Officer of CytoSorbents Corporation, stated, "These trial sites and investigators are amongst some of the most productive and influential in sepsis and critical care research. Their desire to join our trial complements a growing number of investigators at outstanding tertiary care hospitals in Germany, Austria, and the United Kingdom that are collaborating with CytoSorbents on numerous studies. We are pleased to welcome them to our trial."
About CytoSorbents Corporation
CytoSorbents is a critical care focused therapeutic device company using blood purification to modulate the immune system -- 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®, 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™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company's website: http://www.cytosorbents.com
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.