Company Press Releases Back
CytoSorbents Corporation Announces Additional Data From European Sepsis Trial
Wednesday September 7, 2011
MONMOUTH JUNCTION, NJ--(September 7, 2011)- CytoSorbents Corporation (OTC.BB: CTSO.OB - News), a critical care-focused company using blood purification to treat life-threatening illnesses, announced additional data from its recently completed European Sepsis Trial using CytoSorb™, a first-in-class extracorporeal cytokine filter approved for use in the European Union. The Germany-based, randomized, controlled, multi-center trial evaluated the use of CytoSorb™ plus standard of care therapy versus standard of care therapy alone in patients with severe sepsis or septic shock in the setting of lung injury. Data from 100 patients were used to evaluate the safety of CytoSorb™ treatment. Due to a patient randomization issue that was subsequently corrected by institution of electronic randomization, the last 43 patients that completed the trial were used to evaluate clinical efficacy. At the time of enrollment, most of these 43 patients (25 control, 18 treated) had septic shock (94% vs. 100% control) and acute respiratory distress syndrome (67% vs. 56% control), while many had renal failure requiring renal replacement therapy (39% vs. 24% control) before entering the trial. The presence of multiple organ failure reflects the severity of illness in these patients and confers a high expected rate of mortality.
Analysis of clinical data from the European Sepsis Trial suggest that CytoSorb™ treatment has a protective benefit, particularly in those at highest risk for death in sepsis. Recently, the Centers for Disease Control and Prevention (CDC) highlighted that patients aged 65 years and older accounted for two-thirds of all hospitalizations for sepsis from 2000-2008, and were responsible for doubling sepsis hospitalizations during that period (http://www.cdc.gov/nchs/data/databriefs/db62.pdf). Age is one of the strongest predictors of death and is consistent with our own data showing that patients aged 65 years and older had a nearly 5-fold greater risk of death than younger patients. In these patients, CytoSorb™ treatment resulted in a statistically significant improvement in 14-day mortality (0% vs 36% control, p = 0.04, n = 21) with trends to benefit in 28-day mortality (40% vs 45% control), fewer mechanically ventilated patients at 28 days (60% vs 73% control), and improvements in MODS and APACHE 2 organ failure scores during treatment. These data suggest that 7 days of CytoSorb™ treatment is protective for up to 14 days in this elderly population and that longer treatment with CytoSorb™, beyond the 7-day treatment limitation of the trial, could yield even greater benefit to these patients.
As expected, there is also a good correlation between CytoSorb™ cytokine reduction and outcome in patients with highly elevated IL-6 levels (greater than or equal to 1,000 pg/mL) or IL-1ra (greater than or equal to 16,000 pg/mL) which are both known, independent predictors of mortality in sepsis. In these patients, CytoSorb™ treatment showed positive trends to benefit in 28-day all-cause mortality (0% vs 62.5% control, n = 14), fewer patients on mechanical ventilation at 28 days (33% vs 88% control), and fewer days in the ICU (23.8 vs 27.5 days control).
CytoSorbents had previously reported that the primary endpoint of the study had been achieved with an average IL-6 reduction of 49.1% (p = 0.01) across the 7-day treatment period. Analysis of other important cytokines demonstrated similar patterns of reduction including MCP-1 (-49.5%, p = 0.002), IL-1ra (-36.5%, p = 0.001) and IL-8 (-30.2%, 0.002) with additional cytokine analysis ongoing. These data further confirm the effectiveness of CytoSorb™ as a broad cytokine filter and its ability to reduce cytokine storm in patients with sepsis. Treatment was well-tolerated across more than 300 treatments without serious device related adverse events.
Dr. Phillip Chan, Chief Executive Officer, stated, "The European Sepsis Trial exceeded our expectations. We demonstrated the safe and effective use of CytoSorb™ as a powerful cytokine filter in critically-ill patients, obtained European regulatory approval for CytoSorb™, and now have data that clinicians can use today to guide their real-world usage of the device. Patients 65 years and older, and patients with high cytokine levels are the ones in greatest need and make up the majority of hospitalized sepsis patients."
Dr. Robert Bartlett, Chief Medical Officer, added, "These data are very encouraging and represent a promising step in establishing CytoSorb™ as a therapy of choice for critical care illnesses. As with all new technologies, clinical usage of CytoSorb™ and future studies will help confirm these initial findings. As we prepare for discussions with the FDA on a US-based study, we plan to do a small dosing study in the near term that incorporates these lessons learned. In the study, we will investigate the effect of longer and more aggressive cytokine reduction on clinical outcome. This is intended to give clinicians the dosing flexibility to use CytoSorb™ safely in a variety of clinical scenarios."
About CytoSorbents and CytoSorb™
CytoSorbents Corporation is a development stage, critical care-focused therapeutic device company using blood purification to treat life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. In March 2011, CytoSorb™, the Company's flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, and can now be sold throughout the European Union (E.U.) under the CE Mark to be used in cases where cytokines are elevated. To the Company's knowledge, this is the first E.U. approved medical device to have the specific indication as a cytokine filter. The goal of CytoSorb™ is to modulate the immune system by removing excessive cytokines, often called "cytokine storm," in critically-ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death. Cytokine storm frequently occurs in fatal diseases commonly seen in medical and surgical intensive care units, such as severe sepsis and septic shock, acute respiratory distress syndrome, serious burn and smoke inhalation injury, trauma and pancreatitis. Current standard of care therapies are mainly supportive and do little to hasten disease recovery. CytoSorb™ represents a new generation of "active" therapies, designed to counter cytokine storm and prevent or mitigate organ failure, potentially helping patients to heal and recover faster, leading to better patient outcome and reduced overall treatment costs. In the Company's recently completed European Sepsis Trial, CytoSorb™ treatment resulted in a statistically significant reduction of a number of key cytokines in patients with severe sepsis or septic shock, and respiratory failure. This was associated with positive clinical improvements in high risk patients. Severe sepsis and septic shock afflicts more than 1 million people in the United States (U.S.), 1.5 million people in the E.U., and an estimated 18 million people worldwide each year, killing one in every three patients despite the best medical treatment. In the U.S., more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. CytoSorb™ therapy is simple yet elegant. As blood is pumped repeatedly through the CytoSorb™ cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. CytoSorb™ is currently manufactured under ISO 13485:2003 Full Quality Systems certification, an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive management systems in place to safely design, develop, manufacture and distribute medical devices in the E.U. Assuming availability of adequate and timely funding, and continued positive results from our clinical studies, the Company intends to commercialize CytoSorb™ in Europe and then seek to commence U.S.-based clinical trials to obtain U.S. regulatory approval. CytoSorb™ is one of a number of different resins the Company has designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy drugs during treatment of cancer with high dose regional chemotherapy, drug detoxification, 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. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and additional CE Mark 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 and timely 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 March 31, 2011, which is available at http://www.sec.gov.
Chief Financial Officer
(732) 329-8885 ext. 816
Source: CytoSorbents Corporation