Healthcare Industry News: Liver Assist Device
News Release - July 6, 2006
Arbios Adds University of California at San Francisco (UCSF) As Fourth Participating Site in the SEPET(TM) Clinical Feasibility TrialLiver Center Joins Albert Einstein, Cedars Sinai and UCSD Medical Centers in Enrolling New Patients
WALTHAM, Mass., July 6 (HSMN NewsFeed) -- Arbios Systems, Inc. (OTC: ABOS ), a company developing proprietary medical devices and cell-based therapies for the many millions of patients each year in liver failure, or those at risk for life-threatening episodes of liver failure, announced that the University of California at San Francisco (UCSF) Medical Center will serve as an additional clinical site in the ongoing feasibility clinical trial for the Company's SEPET(TM) Liver Assist Device. UCSF joins Albert Einstein Medical Center in Philadelphia, Cedars Sinai Medical Center in Los Angeles, and the University of California at San Diego (UCSD) Medical Center as authorized clinical sites for the trial. UCSF Institutional Review Board approval has been received, site training is underway, and patient enrollment should begin shortly.
Timothy J. Davern II, M.D., Associate Professor of Medicine and Transplant Hepatologist at the UCSF Medical Center, is the site's primary investigator. Dr. Davern commented, "We are pleased to take part in the feasibility clinical trial of SEPET(TM), to explore the safety and utility of the device in managing encephalopathy and other consequences of liver failure in our patients. As one of the largest liver transplant centers in the United States, and designated as a "Center of Excellence" by the U.S. Department of Health and Human Services, UCSF manages many cases of liver failure every year, and we are hopeful that SEPET(TM) may represent a superior means for bridging our patients who are experiencing liver failure to successful transplantation or, in cases of ineligibility for transplant, to recovery of their own liver function."
Walter Ogier, President and Chief Executive Officer of Arbios, commented, "We are very excited to have the UC San Francisco Medical Center join the clinical feasibility trial of SEPET(TM). UCSF treats and transplants exceptional numbers of patients with liver failure, and their participation should facilitate successful completion of this important trial."
In May, 2006, Arbios announced favorable interim safety and patient outcome results of the feasibility clinical trial of the SEPET(TM) Liver Assist Device. The objectives of the trial are to assess the safety and tolerability of SEPET(TM), as well as its preliminary effectiveness in reversing liver failure and resultant encephalopathy. Up to 20 patients will take part in the trial. Encephalopathy associated with liver failure is a life-threatening condition involving brain dysfunction, which is caused by toxins that accumulate in the bloodstream. If liver failure is not reversed, it can lead to the shutdown of multiple organs and death. If a patient is eligible for liver transplantation, treatment with SEPET(TM) may help keep the patient alive until a donor organ becomes available. The trial's interim results showed that all patients treated in the trial had met the prospective clinical effectiveness endpoint of the trial, i.e., at least a 2-stage improvement in encephalopathy, and most of the treated patients had been released from the intensive care unit within 48 hours. The trial has recently been expanded to include all four clinical stages of encephalopathy.
The SEPET(TM) Liver Assist Device is a sterile, disposable cartridge containing microporous hollow fibers with unique permeability characteristics. When a patient's blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (i.e., hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration). These substances would otherwise progressively accumulate in the patient's bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs, including the brain and kidneys, and suppressing the function and regeneration of the liver. SEPET(TM) is designed for use with standard blood dialysis systems available in hospital intensive care units.
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, contaminated herbal medicines, or toxic mushrooms. 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.
Arbios Systems, Inc. is a publicly traded medical device and cell-based therapy company based in Massachusetts and in California that is engaged in the discovery, acquisition and development of proprietary Liver Assist Devices and new technologies useful in the diagnosis and treatment of liver failure. Arbios' products in development include the SEPET(TM) Liver Assist Device, a novel blood purification therapy and the HepatAssist(TM) Cell-Based Liver Support System, a bioartificial liver. 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 goals and results of clinical trials, compliance with regulatory requirements, labeling of the Company's products, the need for subsequent substantial additional financing to complete clinical development of its products, future markets and demand for the Company's products, and Arbios' ability to successfully market its products and technologies. 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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