WALTHAM, Mass., Sept. 07 /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 positive results from the completed feasibility clinical trial of its SEPET(TM) Liver Assist Device, in which 79% of patients met the primary clinical effectiveness endpoint. The results will be published tomorrow at the 9th International Symposium on Albumin Dialysis in Liver Disease (ISAD) as a research abstract authored by Fred Poordad, MD, Chief of Hepatology and Liver Transplantation at Cedars-Sinai Medical Center, Los Angeles, CA, a Principal Investigator in the clinical trial, and other study participants.
In addition, Jacek Rozga, MD, Ph.D., Chief Scientific Officer and Founder of Arbios Systems, Inc. and a co-author of the abstract, will deliver an oral presentation of the clinical trial results tomorrow at the ISAD medical conference, being held in Warnemunde, Germany. He also previewed the results yesterday in a scheduled oral presentation at the Annual Meeting of the European Society for Artificial Organs (ESAO) in Krems, Austria.
Arbios’ SEPET(TM) Liver Assist Device is a novel large-pore blood filter that is being studied in chronic liver disease patients for its potential to promote improvements in liver function following acute exacerbation of liver failure, through its ability to selectively reduce the level of circulating toxins of hepatic failure as well as inflammatory mediators and inhibitors of liver regeneration. According to the American Liver Foundation, chronic liver disease is the tenth leading cause of death in the United States, resulting in approximately $10 billion in annual healthcare costs. 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.
“We are pleased that the final results of our SEPET(TM) feasibility trial appear to have confirmed the safety and tolerability of the device and are particularly excited at the achievement of unusually rapid clinical responses in most patients, many within the first hours of treatment,” commented Walter Ogier, President and Chief Executive Officer of Arbios. “The successful completion of this study serves as the foundation for developing an appropriately powered, randomized, controlled pivotal clinical trial of SEPET(TM) and we look forward to continuing to work with the FDA in the near- term to secure allowance to proceed with this important trial. The excellent final results of the feasibility trial, and their acceptance for oral presentation at the ISAD conference, also give us further confidence in seeking potential earlier commercialization of the SEPET(TM) device in Europe under the CE Mark.”
“Chronic liver failure represents a significant unmet need, as patients often rapidly decline while waiting to undergo or become eligible for liver transplant surgery and this problem is exacerbated by a shortage of livers. Furthermore, a large majority of patients do not have the option of receiving a transplant,” commented Dr. Rozga. “The results from this feasibility study, representing clinical outcomes data that have now been fully monitored and analyzed, strongly support further clinical trials of the SEPET(TM) liver assist device, including a pivotal clinical trial leading to product registration in the US. I am excited that SEPET(TM) may become a viable option to serve as a bridge therapy for healing and regeneration of livers as well as a potential bridge to successful liver transplantation in eligible patients.”
This single arm, uncontrolled SEPET(TM) feasibility study was conducted in 15 patients at three major liver transplant hospitals (Cedars Sinai Medical Center, Los Angeles; Albert Einstein Medical Center, Philadelphia; and University of California Medical Center, San Diego) under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE). The study enrolled patients suffering hepatic encephalopathy (HE) (also known as liver coma) ranging from Grade 1 to Grade 3. Fourteen patients were treated with at least one typically 5 -- 6 hour round of SEPET(TM) treatment, receiving an average of less than two, and a maximum of four, sequential daily treatments until a stable, durable disease response was achieved. Final analysis of the clinical trial results confirmed a high rate of achievement of the primary endpoint for clinical effectiveness with 11/14 (79%) subjects showing full resolution or a reduction in HE by at least two grades. The responses were generally rapid and observed within 48 hours after initiation of treatment, with many occurring during the first treatment. 13/14 (93%) patients’ responses were sustained over the 30-day follow-up period, and improved overall liver function was documented as determined by biochemical measures. Just one out of the 14 patients treated proved refractory to repeated SEPET(TM) treatment, however achieving a single-grade improvement in their encephalopathy. Two additional patients had treatment halted early, prior to achievement of stable response, due in one case to mild bleeding at a catheterization site and in the other to malfunction of a (non-Arbios) dialysis machine.
All patients survived until the end of the 30-day follow-up period and 3 patients were subsequently transplanted with a donor liver. SEPET(TM) treatment was generally well-tolerated and had no negative effects on vital signs (heart rate, blood pressure and respiration) and base blood chemistries. Expected moderate reductions in blood platelets were observed, none with critical consequence. An adverse event of renewed, mild bleeding from a site of prior recent trauma, categorized as severe, was not associated with a low platelet count and was likely caused by the use of heparin for anticoagulation, which is commonly utilized in extracorporeal blood therapy. All treatment-related adverse events were expected and typical of extracorporeal blood therapy procedures, and all were resolved satisfactorily with indicated treatment. FDA has allowed a SEPET(TM) protocol amendment involving discretionary substitution of an alternative anticoagulation method, utilizing sodium citrate instead of heparin, which is anticipated to reduce bleeding risk in subsequent treatments.
About the SEPET(TM) Liver Assist Device
The SEPET(TM) Liver Assist Device is a sterile, disposable cartridge containing microporous hollow fibers with proprietary 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.
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 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 adversely 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, 2006, and to our subsequent Quarterly Reports on Form 10-Q, 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, President and CEO of Arbios Systems, Inc.,+1-781-839-7293, or Doug MacDougall of MacDougall Biomedical Communications+1-508-647-0209
Web site: http://www.arbios.com/
