WALTHAM, Mass., Oct. 27 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. , a company developing proprietary medical devices and cell-based therapies for the millions of patients each year who experience or are at risk for life-threatening episodes of liver failure, today announced the upcoming presentation of data from the first five patients treated with the SEPET(TM) Liver Assist Device in the Company’s ongoing feasibility IDE clinical trial. The data will be presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place at the John B. Hynes Convention Center in Boston, Massachusetts from October 27, 2006 to October 31, 2006.
A poster, entitled “A New Liver Support Device: First Results of a Phase I Clinical Trial in Patients with Acute-on-Chronic Liver Failure,” will be presented by Santiago Munoz, M.D., FACP, Chairman, Division of Hepatology, Director, Einstein Center for Liver Disease at Albert Einstein Medical Center in Philadelphia, on Sunday, October 29, 2006 in Exhibit Hall C at booth #236. Dr. Munoz is one of the principal investigators in the SEPET(TM) clinical trial.
Arbios also announced that the clinical trial is currently recruiting its tenth patient. The aim of the study is to assess the safety and tolerability of the SEPET(TM) Liver Assist Device as well as its preliminary effectiveness in reversing liver failure and resultant encephalopathy. Patients with acute- on-chronic liver failure, including encephalopathy, are eligible to take part in the study.
As summarized in the AASLD Abstract (#483), after one or two days of treatment with SEPET(TM), patients demonstrated statistically significant improvement in the Glasgow Coma Score and the Fischer Index, representing common measurements of the severity of encephalopathy. In addition, there were trends towards improvement of blood ammonia levels and MELD score, representing common measurements of the severity of liver failure. A majority of patients were discharged from the intensive care unit within 48 hours of treatment with improvement of encephalopathy stage. Treatment was judged to be well tolerated. Preliminary reports for additional patients treated to date in the clinical trial have been similarly favorable.
Commenting on these findings, Walter Ogier, President and Chief Executive Officer of Arbios, stated, “The data to be presented in this interim analysis of the SEPET(TM) clinical trial suggest that treatment with SEPET(TM) may be providing substantial benefit to critically ill patients. We continue to be very encouraged that this first clinical trial of the SEPET(TM) Liver Assist Device will be successful and represent a major step forward towards the availability of an important new treatment for patients with liver failure.”
The abstract is co-authored by Dr. Munoz and Fred C. Poordad, M.D., Chief of Hepatology at the Center for Liver Disease and Transplantation at Cedars Sinai Medical Center in Los Angeles; John M. Vierling, M.D., professor of Medicine and Surgery, Director of Baylor Liver Health and Chief of Hepatology at the Baylor College of Medicine in Houston and Chairman of the Board of Directors of Arbios; Jacek Rozga M.D., Ph.D., Chief Scientific Officer of Arbios; and other colleagues.
During treatment, patients’ blood was perfused using a Prisma (Gambro) dialysis system for up to 6 hours though a SEPET(TM) cartridge containing a hollow-fiber membrane permeable to small molecules as well as intermediate molecular weight blood components up to 100 kilodaltons in weight. Vital signs and biochemistries were closely monitored before, during and after each treatment. The clinical trial was recently broadened to accept patients with combined liver failure and renal failure (Type 2 Hepato-Renal Syndrome).
The full abstract is available on the AASLD website at: www.aasld.org.
About the SEPET(TM) Liver Assist Device
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.
In September 2006, Arbios Systems received allowance from the U.S. Food & Drug Administration to expand the eligibility criteria for the SEPET(TM) clinical trial to include patients with hepatic encephalopathy due to combined liver and kidney (renal) failure. This allowance is expected to significantly widen the pool of patients eligible for enrollment in the trial and represents the Company’s first step towards investigating use of the SEPET(TM) Liver Assist Device in multiple organ failure indications. Current clinical sites for the trial include Albert Einstein Medical Center in Philadelphia, Cedars Sinai Medical Center in Los Angeles, the University of California at San Diego (UCSD) Medical Center, and the University of California at San Francisco (UCSF) Medical Center.
About Arbios Systems
Arbios Systems, Inc. is developing proprietary medical devices and cell- based therapies to enhance the survival of millions of patients each year who experience, or are at risk for, life-threatening episodes of liver failure. The Arbios product candidate portfolio includes the SEPET(TM) Liver Assist Device, a novel blood purification therapy that provides enhanced “liver dialysis,” and the HepatAssist(TM) Cell-Based Liver Support System, a bioartificial liver that combines blood detoxification with liver cell therapy to replace whole liver function in patients with the most severe forms of liver failure. For more information on the Company, please visit 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.
Arbios Systems, Inc.
CONTACT: Walter C. Ogier of Arbios Systems, Inc., +1-781-839-7293,wogier@arbios.com; or Paula Schwartz - Investors, +1-917-322-2216, or PatGarrison - Media, +1-917-322-2567, both of RX COMMUNICATIONS GROUP; or DougMacDougall of MacDOUGALL BIOMEDICAL COMMUNICATIONS, +1-508-647-0209
