MONMOUTH JUNCTION, N.J., Nov. 22, 2016 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ :CTSO ), highlights the first successful treatment of Dengue Shock Syndrome caused by Dengue virus infection using CytoSorb® as reported in a recent issue of the Journal of Evidence Based Medicine Healthcare.
Dengue virus infection is one of the most prevalent mosquito-borne illnesses in the world, endemic in 112 countries, putting an estimated 40% of the world's population at risk. An estimated 100 million people each year contract dengue infection, causing high fever and severe flu-like symptoms that are typically self-limited. However, in approximately a half million people, symptoms progress rapidly to life-threatening Dengue Hemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS), where patients develop severe shock with very low blood pressure, liver injury and other vital organ dysfunction, tissue edema, and significant problems with blood clotting contributing to a high risk of bleeding. Other than supportive care therapy, there are no specific treatments for either DHF or DSS. The excessive production of cytokines, or cytokine storm, has often been implicated as a major contributor to severity of illness and risk of death in dengue infection. It has been suggested that the reduction of elevated levels of soluble inflammatory mediators such as cytokines and activated complement could be therapeutic.
Dr. Zafir A. Khan, Director of the Department of Internal Medicine at Noble Hospital in Pune, India, recently published the first CytoSorb treatment case report of a 32 year old man infected with dengue virus who was transferred to his intensive care unit (ICU) from an outside hospital after developing progressively worsening multiple organ dysfunction syndrome (MODS), including septic shock, kidney and liver dysfunction, and respiratory distress. Following transfer, the patient continued to worsen, with acute respiratory distress syndrome (ARDS) requiring mechanical ventilation, a systemic inflammatory response syndrome (SIRS), adverse change in mental status due to liver toxins, and acute kidney failure with an APACHE II score of 27, predicting an ICU mortality of approximately 55%.
At this point, CytoSorb blood purification therapy was initiated, in addition to renal replacement therapy for kidney failure. The patient was treated with CytoSorb for 6 hours per day on Days 2, 4, and 6 after ICU admission, and was stabilized, showing gradual and significant improvement in clinical and laboratory parameters by the third treatment. With continued supportive care, the patient ultimately regained function of his vital organs, was discharged from the ICU on Day 13, and recovered.
Dr. Khan concluded in the report, "In our case, [the] CytoSorb device was added as a supportive therapy to address underlying pathology due to cytokine storm. The device helped to stabilize and revive the dengue patient with multiple organ dysfunction syndrome (MODS) and shock. [The] majority of laboratory parameters were within the normal range after the therapy and no major adverse events were reported during or after the CytoSorb therapy. CytoSorb seems to be an interesting and safe extracorporeal therapy option to stabilize and help dengue patients with MODS to recover. Further research is warranted in a larger pool of patients to understand the clinical role of this device in the management of dengue fever."
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 42 countries around the world, as a safe and effective 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 such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. 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, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial - a multi-center, randomized controlled study that has demonstrated the safety of intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery. In 2017, the company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 17,000 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 and contract funding in excess of $18 million from DARPA, the U.S. Army, the U.S. Air Force, 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 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL, HemoDefend™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites: http://www.cytosorbents.com and http://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 9, 2016, 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.
SOURCE CytoSorbents Corporation