Company Press Releases Back
CytoSorbents, Inc. Comments on CytoSorb(TM) and the Swine Flu Outbreak
Wednesday May 6, 2009, 8:30 am EDT
MONMOUTH JUNCTION, NJ--(MARKET WIRE)--May 6, 2009 -- CytoSorbents, Inc. comments on the current swine flu outbreak and highlights the urgent need for improved therapies for influenza and other respiratory viruses. In particular, potentially virulent pathogens such as avian flu (H5N1 subtype), swine flu (H1N1 subtype), and the SARS virus can quickly kill a large percentage of those infected. According to the Centers for Disease Control, normal seasonal influenza afflicts 15-60 million people in the United States each year, hospitalizing more than 200,000, and directly contributing to the deaths of 36,000 people annually. Although these numbers are significant, in contrast, the 1918 Spanish influenza pandemic infected an estimated one third of the world population, killing nearly 50 million people. Highly virulent flu strains have the ability to evade neutralization by the immune system, leading to a prolonged and intense infection that can lead to severe sepsis and death. Although the virus itself has destructive capability, the body's own aggressive immune response and "cytokine storm" are recognized as leading drivers of mortality in these patients. Cytokines are normally helpful proteins that control the immune system. In severe sepsis due to influenza, however, cytokines are often produced in excessive, toxic quantities leading to acute respiratory distress syndrome (severe lung inflammation), organ failure, and numerous complications that often result in death. Anti-viral therapy such as Tamiflu(TM), Relenza(TM) and amantadine may slow viral infection if used early enough and if resistance is not an issue. But given the major role that cytokine storm is believed to play in the pathogenesis of these deadly viruses, more options are needed to directly address this critical issue now.
CytoSorbents, Inc. and its parent, MedaSorb Technologies Corporation (OTC BB:MSBT.OB - News), have developed CytoSorb(TM), a highly-porous polymer resin that acts as a cytokine filter and can broadly remove cytokines from blood to potentially treat cytokine storm. Treatment is straightforward. A patient's blood is pumped through a CytoSorb(TM) cartridge where cytokines and toxins are adsorbed and removed by the resin. Treated blood is then returned to the patient. This highly efficient blood purification device has demonstrated the ability to remove up to 90% of certain cytokines from blood within a single treatment period during in vitro blood circulation experiments. In animal bacterial sepsis studies performed at the University of Pittsburgh Medical Center, CytoSorb(TM) significantly improved hemodynamic stability and short-term survival while simultaneously reducing cytokine levels with a single treatment, compared to sham-treated control animals. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using its flagship CytoSorb(TM) device to treat up to 100 patients with severe sepsis in the setting of respiratory failure. All of these patients are on mechanical ventilation and have either acute lung injury or acute respiratory distress syndrome, similar to what is expected to be seen in a major influenza pandemic. The results from this study may pave the way for the potential future use of CytoSorb(TM) in the treatment of critically ill influenza patients.
CytoSorbents Chief Executive Officer, Phillip Chan, MD, PhD, stated, "It has been well-accepted that severe sepsis, caused by either bacteria or viruses, has two important facets. One is the infectious agent that can be treated with antibiotics or antiviral medications. But the other is the body's unregulated immune system and cytokine storm that causes much of the organ damage and death in patients with sepsis. Little exists to treat this major problem. CytoSorb(TM) is a powerful technology that could fill this gap."
Dr. Chan continued, "The alarm raised by the current swine flu outbreak demonstrates how vulnerable we are to medical emergencies such as these, be they natural or man-made. In particular, it has highlighted a key weakness in our armamentarium to treat severe infection -- the inability to effectively address cytokine storm. Although CytoSorb(TM) is currently an investigational device and its applicability in influenza remains to be seen, it has the clear potential to be a leading therapy to treat cytokine storm and make a real difference in getting patients well."
Tamiflu(TM) and Relenza(TM) are trademarks of Roche Holding AG and GlaxoSmithKline plc, respectively
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. MedaSorb Technologies Corporation believes that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on April 10, 2009, which is available at http://www.sec.gov.
Contact:MedaSorb Technologies Corporation
(732) 329-8885 ext. 816
Source: MedaSorb Technologies