Company Press Releases Back
MedaSorb Technologies Corporation Provides Clinical Update
Friday November 13, 2009 On 8:30 am EDT
MONMOUTH JUNCTION, NJ--(November 13, 2009) - MedaSorb Technologies Corporation (OTC.BB:MSBT - News) and its wholly-owned subsidiary, CytoSorbents, Inc., provided an update of its clinical program.
Dr. Phillip Chan, Chief Executive Officer, stated, "As we welcome many new investors to the company, I wanted to give a brief update on our European Sepsis Trial. As many know, MedaSorb has developed a powerful blood purification technology platform that can remove drugs, proteins, toxins and other substances from blood and physiologic fluids. With our flagship product CytoSorb�, we are currently conducting one of the largest randomized, controlled clinical trials of its kind to treat patients with severe sepsis and respiratory failure by directly attempting to reduce 'cytokine storm' that often leads to organ failure and death in this disease. Severe sepsis and cytokine storm are particularly relevant today, as they have likely contributed to the deaths of many people infected with the H1N1 swine influenza virus in countries across the world. By potentially reducing these toxic cytokine levels in the blood, we hope CytoSorb� can prevent and limit organ injury, giving patients time to heal and recover."
Preliminary Clinical Data from Sepsis Pilot Study We previously discussed that the first 22 patients in our European Sepsis Trial were categorized into a pilot study. Treatment was well-tolerated in this study and there were no serious device related adverse events. We currently have fully-monitored, completed data sets on 13 of these patients. These represent all twelve patients from a major, well-known, academic university hospital as well as one patient from another large clinical trial site. Seven of these patients were treated with CytoSorb� and standard of care therapy, while six others were in the control group receiving standard of care therapy alone. We are encouraged that an analysis of the data demonstrates improvements in many of the secondary and exploratory endpoints of the trial in the treatment group compared to the control group including:
·   28-day and 60-day all cause mortality
·   Ventilator free days
·   Pace of ventilator weaning
·   Organ failure scores
·   Vasopressor use
·   Days in the intensive care unit
These objective endpoints in the treatment of severe sepsis are important. First, improvements in these key outcomes are difficult to accomplish but are directly associated with improved patient outcome and survival. Secondly, these are parameters used by critical care physicians to judge how patients are doing and are predictors of length of stay and cost of stay in the intensive care unit. Lastly, improvements in these criteria are consistent with how CytoSorb� is intended to work. Cytokine storm-induced organ failure such as acute respiratory distress syndrome requiring mechanical ventilation, hemodynamic shock requiring vasopressors, and renal failure requiring dialysis is well-documented. Reduction of cytokine storm by CytoSorb� is intended to reduce organ failure and the need for these types of interventions and we are pleased to see this correlation.
European Sepsis Trial – Including our Sepsis Pilot Study, we have enrolled a total of 39 patients in our trial, including 17 patients under a new protocol designed to improve data quality and enhance recruitment. To complete our trial, we are looking to enroll an additional 40 patients, but if needed, can go up to 60. We have increased the number of participating trial sites to 12 and are currently leveraging our existing hospital network to include several additional medical intensive care units. This should benefit our enrollment by increasing the number of patient candidates that can participate in our trial. In addition, we are entering what is expected to be a busy flu and pneumonia season, which are major causes of severe sepsis. With a successful completion of our trial, we continue to anticipate CE Mark approval and potential for initial commercial sales of our device in Europe in 2010. We are currently working in parallel to prepare our CE Mark application which will be finalized once our trial is successfully completed.
"We continue to press forward with other potential clinical applications of our blood purification technology," said Dr. Chan. "For example, the U.S. government has now declared the current H1N1 influenza pandemic a national public health emergency, enabling the FDA to provide Emergency Use Authorization (EUA) of drugs, devices, diagnostic tests, and biological products that have not yet been approved, cleared or licensed by the FDA. This, as well as the increased attention to H1N1 influenza by government funding agencies, opens up a number of opportunities for us that we are actively pursuing for our CytoSorb� device. The link between cytokine storm, mortality and highly virulent strains of influenza like H5N1 avian flu, 1918 H1N1 Spanish Influenza, as well as other respiratory viruses like SARS coronavirus can be found in a number of non-company publications included towards the end of our publication list,
There remains a significant unmet medical need for treatment of critically-ill influenza patients who have failed protection of vaccines and early treatment with anti-viral therapies."
Dr. Chan concluded, "In summary, we are pleased to see a potential clinical benefit of CytoSorb� in a relatively small number of patients in our Sepsis Pilot Study, but recognize this was a small data set of 13 patients and would caution investors to avoid extrapolating these results to the larger trial which is still underway. We believe 2010 will be a pivotal year for the company as we hope to complete our European Sepsis Trial successfully and transition from a development stage to a commercial stage company. We have a number of interesting opportunities ahead of us and we thank our shareholders for their continued support."
About MedaSorb, CytoSorbents and and CytoSorb™
MedaSorb Technologies Corporation, and its operating subsidiary CytoSorbents, is a therapeutic device company in clinical trials to treat severe sepsis, often called “overwhelming infection”, with a novel blood purification device called CytoSorb™. Severe sepsis is typically caused by bacterial infections like pneumonia, or viral infections like influenza. It afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Much of the organ failure and mortality in severe sepsis is caused by the abnormal massive production of cytokines by the immune system, often called “cytokine storm”. CytoSorb™ is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped 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. The Company is currently conducting its European Sepsis Trial – a multi-center, randomized, controlled clinical trial using its flagship CytoSorb™ device to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb™ in the European Union. CytoSorb™ is one of a number of different resins designed for different medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, treatment of rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company’s website: 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. MedaSorb Technologies Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and 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 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-KSB filed with the SEC on April 10, 2009, which is available at http://www.sec.gov.
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Source: MedaSorb Technologies