WALTHAM, Mass., March 16 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. , a biomedical device and cell therapy company developing proprietary liver assist products for the treatment of liver failure, today announced that the Food & Drug Administration (FDA) has allowed expansion of the clinical feasibility trial of its SEPET(TM) liver assist device via broadened patient eligibility criteria.
Under the new eligibility criteria, patients enrolled in the SEPET(TM) trial must be experiencing an acute exacerbation of chronic liver failure manifested as encephalopathy, in any of its clinical Stages 1 to 4 (Stage 4 encephalopathy patients are in a coma). Under the prior eligibility criteria, only patients experiencing Stages 2 or 3 encephalopathy were allowed to participate in the trial.
Encephalopathy is a life-threatening condition involving brain dysfunction, which is caused by toxins that accumulate in the bloodstream during liver failure. In its most severe form, encephalopathy leads to coma and, if liver failure is not reversed, to the shutdown of multiple organs. The clinical trial is currently underway at Albert Einstein Medical Center in Philadelphia and Cedars Sinai Medical Center in Los Angeles.
Walter C. Ogier, President and Chief Executive Officer of Arbios, commented, “The FDA’s allowance of broadened patient eligibility criteria for the SEPET(TM) clinical trial, in part, reflects our experience that those patients who have received SEPET(TM) therapy to date appear to have tolerated the device well and to have responded to the therapy with rapid improvement of their encephalopathy. The inclusion of Stage 1 disease should enable treatment of patients whose encephalopathy has not fully responded to conventional care and who must remain hospitalized, while inclusion of Stage 4 disease should permit treatment of those patients at greatest risk who could potentially benefit most from SEPET(TM) therapy.” Mr. Ogier further noted that the Company expects these changes to expedite enrollment of the trial and to facilitate the design of future clinical trials and development of eventual labeling for the product.
The goal of the current clinical feasibility trial is to assess the safety of the SEPET(TM) liver assist device, as well as its potential 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. Going forward this year, Arbios’ goals include the completion of the current feasibility clinical trial for SEPET(TM) by mid- year, and the initiation of a further feasibility trial in chronic Hepatitis B patients in Asia.
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 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 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 SEPET(TM), a novel blood purification therapy and HepatAssist(TM), a bioartificial liver combining liver cell therapy and device-based detoxification. 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 obtaining clinical site approvals, the timing of clinical trials, manufacturing SEPET(TM) cartridges, enrolling patients, compliance with regulatory requirements, the goals and results of the clinical tests to be conducted by the Company, labeling of the Company’s products, the need for subsequent substantial additional financing to complete clinical development of its 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, 2004 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- 2(TM) are trademarks of Arbios Systems, Inc.
Arbios Systems, Inc.
CONTACT: Walter Ogier, President & CEO, Arbios Systems, Inc.,+1-781-839-7293, wogier@arbios.com; Paula Schwartz (Investors), +1-917-322-2216, or Pat Garrison (Media), +1-917-322-2567, both of RX CommunicationsGroup
Web site: http://www.arbios.com/
