WALTHAM, Mass., Feb. 22 Arbios Systems, Inc.(OTC Bulletin Board: ABOS) announced today that the Company has receivedconditional approval from the U.S. Food and Drug Administration ("FDA") of anInvestigational Device Exemption ("IDE") to begin the pivotal clinical trialfor SEPET(TM), Arbios' extracorporeal (outside the body) artificial liverassist device for blood purification of chronically ill patients sufferingfrom acute liver failure. Permission was granted to initiate the trial whilethe Company responds to the FDA's conditions and request for additionalinformation. In particular, FDA has requested a survival primary endpoint,which could potentially increase the total number of patients required for thetrial. The trial design proposed by the Company has a primary endpoint of atwo-stage drop in hepatic encephalopathy and its secondary endpoints includeseveral survival based endpoints. The Company is refining its position that atwo-stage drop in hepatic encephalopathy is clinically meaningful and anappropriate primary endpoint for the trial. The Company is requesting ameeting with FDA to discuss this issue and to confirm the overall design ofthe trial.
"While we are pleased to have received FDA permission to start the SEPETpivotal trial, we will work diligently with FDA with the hope of identifying amutually acceptable primary endpoint," commented CEO and President Shawn Cain."We currently do not have the financial resources to fund the pivotal trialand our ability to finance the Company is contingent upon, among other issues,agreement on a primary endpoint with a reasonable number of patients requiredfor the trial."
"Hepatic encephalopathy ("HE") represents one of the most frequentcomplications of cirrhosis mandating hospitalization and a two-stageimprovement of HE has significant clinical benefits to patients," noted Dr.John Vierling, M.D. FACP Chairman of Arbios and Professor of Medicine andSurgery and Chief of Hepatology at the Baylor College of Medicine."Specifically, patients with grade 3 or 4 HE are intubated in the intensivecare unit ("ICU") to prevent lethal aspiration pneumonia and can betransferred out of the ICU after a reduction of 2 grades of HE, unless othercomplications require continued ICU care. Similarly, reduction of HE to grade0, 1 usually permits discharge from the hospital and management as anoutpatient, reducing exposure to antibiotic-resistant organisms in hospitalsand eliminating risks associated with medical errors," further commented Dr.Vierling.
About Arbios' SEPET(TM) Liver Assist Device
The SEPET(TM) Liver Assist Device is a sterile, disposable cartridgecontaining microporous hollow fibers with proprietary permeabilitycharacteristics. When a patient's blood is passed through these fibers, bloodplasma components of specific molecular weights are expressed through themicropores, thereby cleansing the blood of harmful impurities (e.g., hepaticfailure toxins as well as various mediators of inflammation and inhibitors ofliver regeneration). These substances would otherwise progressivelyaccumulate in the patient's bloodstream during liver failure, causinghypotension, increasing risk of sepsis development and accelerating damage tothe liver, lungs and other organs, including the brain and kidneys, andsuppressing the function and regeneration of the liver. SEPET(TM) is designedfor use with standard blood dialysis systems available in hospital intensivecare units.
According to the American Liver Foundation, liver disease is among the topseven causes of death in adults in the United States between the ages of 25 --64. In fact, one out of every 10 Americans has some form of liver disease.There is currently no satisfactory therapy available to treat patients inliver failure, other than maintenance and monitoring of vital functions andkeeping patients stable through provision of intravenous fluids