CytoSorb, the Wuhan Coronavirus, and Cytokine Storm
MONMOUTH JUNCTION, N.J., Jan. 28, 2020 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader with more than 80,000 global treatments of its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, highlights the recent publication in The Lancet entitled, "Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China." The article notes the correlation of high levels of circulating inflammatory cytokines, or "cytokine storm," with severity of illness in patients infected with the Wuhan coronavirus (2019-nCoV). These data provide the rationale to potentially use CytoSorb, the first specifically-approved extracorporeal cytokine adsorber in the European Union, in this setting. CytoSorb is distributed in 58 countries worldwide, and is available in Hong Kong, Vietnam, Malaysia, France, and Australia where patients infected with the virus have been reported.
In this publication, Huang, et al. describe the characteristics and clinical course of hospitalized patients infected with the Wuhan coronavirus who did, or did not, require treatment in the intensive care unit (ICU). Those that were admitted to the ICU, particularly those with severe disease, exhibited significantly higher levels of inflammatory cytokines compared to those that did not. This "cytokine storm" can trigger a viral sepsis in coronavirus infection, where viral replication and excessive, uncontrolled systemic inflammation can lead to pneumonitis, acute respiratory distress syndrome, respiratory failure, shock, organ failure, secondary bacterial pneumonia, and potentially death. This same correlation between cytokine storm and severity of illness was observed previously in both SARS and MERS patients.
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "CytoSorb has been used to control deadly inflammation in tens of thousands of treatments in patients with either bacterial or viral sepsis. Although CytoSorb has not yet been specifically used to treat patients infected with this newly emergent coronavirus, we believe it can play an important role, with or without anti-viral therapies, in the treatment of this highly inflammatory illness."
The Wuhan coronavirus has a relatively asymptomatic incubation period for up to 14 days, often marked only by dry cough and fatigue, when the afflicted can transmit the virus to others, followed by fever and the development of viral pneumonia. The spread of the coronavirus has also been facilitated by international travel.
Researchers in Hong Kong have warned that the number of people infected by the Wuhan coronavirus (2019-nCoV) could be 30 times more than the reported 4,500 cases that have killed 106 people already, with now 5 confirmed cases and more than 100 suspected cases in the U.S. The contagiousness, lack of specific treatments or vaccines, and feared mortality has created a health scare in China and in many countries around the world similar to the 2002-2003 SARS (Severe Acute Respiratory Syndrome) coronavirus outbreak in China that infected 8,098 people and killed 774 (or 1 in 10 died), and the 2012 MERS (Middle East Respiratory Syndrome) coronavirus contagion with 2,494 confirmed cases and 858 deaths to date (approximately 1 in 3 died).
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. The Company has also initiated the company-sponsored U.K. TISORB trial evaluating the removal of ticagrelor in emergency cardiac surgery patients. CytoSorb® has been used in more than 80,000 human treatments to date.
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. Its technologies have received non-dilutive grant, contract, and other funding of approximately $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
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. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 7, 2019, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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