Healthcare Industry News: SEPET
News Release - May 15, 2006
Arbios Systems Presents Positive Interim Safety and Patient Outcome Results From the SEPET(TM) Liver Assist Device Clinical TrialAll Patients Treated with SEPET(TM) Tolerated Therapy Well and Met Clinical Endpoint for Improvement of Hepatic Encephalopathy
WALTHAM, Mass., May 15 (HSMN NewsFeed) -- Arbios Systems, Inc. (OTC: ABOS ), a medical device and cell-based therapy company developing proprietary liver support products, today presented interim safety and patient outcome results of its feasibility clinical trial of the SEPET(TM) Liver Assist Device, which demonstrated that all patients treated with the device tolerated the therapy well and met the clinical endpoint for improvement of hepatic encephalopathy (also known as "liver coma"). The presentation was given by Walter C. Ogier, President and Chief Executive Officer of Arbios, at the Rodman & Renshaw Techvest 3rd Annual Global Healthcare Conference in Monaco, where he also gave a Company overview presentation.
Commenting on today's news, Mr. Ogier stated, "We are encouraged by these favorable, interim trial results with the SEPET(TM) Liver Assist Device. While the number of patients who have received SEPET(TM) therapy is still limited, the favorable disease responses of the patients treated is for us a positive indication of the future potential for this unique liver assist therapy. We were also enthusiastic to see several patients discharged from intensive care so quickly, within 48 hours of the initiation of treatment, when liver failure patients in such serious conditions can typically require a prolonged stay."
Mr. Ogier continued, "We look forward to continued results from this first clinical trial of SEPET(TM), with up to 20 patients taking part. The FDA's recent allowance of expansion of the eligibility criteria to include patients with all clinical stages of hepatic encephalopathy, as well as expansion of the number of centers participating in the trial, should help expedite enrollment and provide experience with a broadened range of disease conditions. Our near term focus is to complete the feasibility clinical trial; we also want to initiate an additional feasibility trial in chronic Hepatitis B patients in Asia. Successful completion of the U.S. feasibility trial should position us to initiate a U.S. pivotal registration trial of SEPET(TM) as well as a smaller CE Mark registration trial in Europe, as anticipated final clinical steps toward commercialization of SEPET(TM)."
About the SEPET Trial
To date, a total of five acute-on-chronic liver failure patients have been enrolled in the SEPET(TM) trial. At the time of treatment, one patient was experiencing Stage II encephalopathy, three patients had Stage III encephalopathy and one patient had Stage IV encephalopathy (the most severe stage). One of the five patients (Stage III) was enrolled but did not receive a course of treatment. Each of the four patients treated received at least one course of SEPET(TM) therapy. All treatments were well tolerated. No serious adverse events were recorded and no negative effects on patients' vital signs (heart rate, blood pressure, and respiration) or base blood chemistries were reported. None of the patients experienced febrile (fever) or allergic reactions to SEPET(TM) therapy.
All treated patients experienced at least a two-grade reduction in their hepatic encephalopathy following one or two days of treatment, with corresponding improvements in the hepatic encephalopathy biochemical index. One patient experienced a recurrence of hepatic encephalopathy several days post-treatment and hospital discharge, attributed to non-compliance with out- patient medications.
Three of the four treated patients were discharged from the Intensive Care Unit within 48 hours, with one patient experiencing various co-morbidities which persisted until liver transplantation. Three of the SEPET(TM) treated patients were successfully bridged to transplantation. The fourth patient was bridged to recovery from encephalopathy and discharged from the hospital. This patient was diagnosed with and later died of metastatic liver cancer unrelated to treatment with SEPET(TM).
The SEPET(TM) clinical feasibility trial is currently underway at Albert Einstein Medical Center in Philadelphia, Cedars Sinai Medical Center in Los Angeles and the University of California at San Diego (UCSD) Medical Center. The primary goals of the trial are to assess preliminary safety, tolerability and efficacy of the device. In addition, data are being collected to assess the potential of SEPET(TM) to serve as a blood purifier to facilitate recovery from liver failure and encephalopathy, to support liver regeneration, and, if a patient is eligible for liver transplantation, to help keep the patient alive until a donor organ becomes available for transplantation. To participate in the trial, a patient must be aged 18 to 65, experiencing an acute episode of a chronic liver condition resulting in hepatic encephalopathy (swelling of the brain) in any of its clinical stages. Encephalopathy manifested as Stage I disease is characterized by mild confusion, while Stage IV encephalopathy patients are in a coma and at risk of organ shutdown and death. Patients enrolled in the study are scheduled to receive a 6-hour course of therapy each day, for a maximum of seven days. Encephalopathy is considered improved if at least a two-stage reduction is observed following treatment with SEPET(TM) (or if a Stage I patient's encephalopathy is fully resolved).
About Chronic Liver Disease
Chronic liver disease is the tenth leading cause of death in the U.S, resulting in approximately $10 billion in annual healthcare costs, according to the American Liver Foundation. The World Health Organization estimates that 20 million people worldwide have cirrhosis of the liver and/or liver cancer, arising predominantly among the estimated 500 million persons (nearly 10% of the world population) who are afflicted with persistent hepatitis B or hepatitis C viral infections. Liver failure may also result from excessive alcohol consumption, aggressive forms of fatty liver disease or other chronic liver disorders. It can also be caused by ingestion of common medications such as acetaminophen. An estimated one to two million persons worldwide die each year from liver failure, with more than 50,000 deaths per year in the United States. Liver failure typically develops slowly, and its progression usually goes unnoticed until it becomes life-threatening. It occurs in persons of all ages but is most common (representing the fifth leading cause of death) among 25 to 65 year olds.
There is currently no satisfactory therapy available to treat patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable through provision of intravenous fluids and blood products, administration of antibiotics and support of vital functions, such as respiration. While a patient's liver may regenerate on its own to varying degrees, a chronic liver failure patient often continues to lose more and more liver cell mass and function as the disease progresses and ultimately needs to undergo liver transplant surgery. A shortage of livers and other factors make such therapy unavailable to the large majority of liver failure patients worldwide.
The SEPET(TM) Liver Assist Device is a novel blood purification therapy designed for use with a standard blood dialysis system. It comprises a sterile, disposable cartridge containing microporous hollow fibers with unique permeability characteristics. When a patient's blood is passed through these fibers, blood plasma of specific molecular weight and size is expressed through the micropores, thereby cleansing the blood of harmful impurities (i.e., hepatic failure toxins such as ammonia, as well as various mediators of inflammation and inhibitors of hepatic regeneration). These substances would otherwise progressively accumulate in the patient's bloodstream during liver failure, accelerating damage to the liver and other organs, including the brain and kidneys, and suppressing the ability of liver cells to function and to proliferate, or regenerate.
Arbios Systems, Inc. is a publicly traded medical device and cell therapy company based in Massachusetts and California. Arbios' portfolio of extracorporeal blood therapies includes the SEPET(TM) Liver Assist Device, a novel blood purification therapy currently undergoing clinical testing for patients experiencing acute exacerbation of chronic liver disease caused by viral hepatitis B, viral hepatitis C or alcoholic cirrhosis, and the HepatAssist(TM) Cell-Based Liver Support System which combines blood detoxification with liver cell therapy intended to provide replacement of whole liver function for patients with acute and severe acute-on-chronic liver failure. HepatAssist(TM) has been shown in a randomized Phase II-III clinical trial to enhance survival of acute liver failure patients eligible for liver transplantation. For further information on the Company, access the website at http://www.arbios.com.
This press release contains forward-looking statements that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the potential for the SEPET(TM) Liver Assist Device, the enrollment in the feasibility clinical trial, the Company's goals, the timing of completion of the clinical trial and the Company's plans regarding a feasibility trial in chronic Hepatitis B patients in Asia, a US pivotal registration trial of SEPET(TM), a smaller CE Mark registration trial in Europe and the potential commercialization of SEPET(TM). These statements represent the judgment of Arbios' management as of this date and are subject to risks and uncertainties that could materially affect the Company. Arbios cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements. Please refer to our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2005 for a description of risks that may affect our results or business conditions. The Company does not undertake any obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events except as required by law. SEPET(TM) and HepatAssist(TM) are trademarks of Arbios Systems, Inc.
Source: Arbios Systems
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