Arbios Systems Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM) Primary Endpoint of the Trial to Be Clarified with FDA
Published: Feb 25, 2008
WALTHAM, Mass., Feb. 22 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. announced today that the Company has received conditional approval from the U.S. Food and Drug Administration ("FDA") of an Investigational Device Exemption ("IDE") to begin the pivotal clinical trial for SEPET(TM), Arbios' extracorporeal (outside the body) artificial liver assist device for blood purification of chronically ill patients suffering from acute liver failure. Permission was granted to initiate the trial while the Company responds to the FDA's conditions and request for additional information. In particular, FDA has requested a survival primary endpoint, which could potentially increase the total number of patients required for the trial. The trial design proposed by the Company has a primary endpoint of a two-stage drop in hepatic encephalopathy and its secondary endpoints include several survival based endpoints. The Company is refining its position that a two-stage drop in hepatic encephalopathy is clinically meaningful and an appropriate primary endpoint for the trial. The Company is requesting a meeting with FDA to discuss this issue and to confirm the overall design of the trial.
"While we are pleased to have received FDA permission to start the SEPET pivotal trial, we will work diligently with FDA with the hope of identifying a mutually acceptable primary endpoint," commented CEO and President Shawn Cain. "We currently do not have the financial resources to fund the pivotal trial and our ability to finance the Company is contingent upon, among other issues, agreement on a primary endpoint with a reasonable number of patients required for the trial."
"Hepatic encephalopathy ("HE") represents one of the most frequent complications of cirrhosis mandating hospitalization and a two-stage improvement of HE has significant clinical benefits to patients," noted Dr. John Vierling, M.D. FACP Chairman of Arbios and Professor of Medicine and Surgery and Chief of Hepatology at the Baylor College of Medicine. "Specifically, patients with grade 3 or 4 HE are intubated in the intensive care unit ("ICU") to prevent lethal aspiration pneumonia and can be transferred out of the ICU after a reduction of 2 grades of HE, unless other complications require continued ICU care. Similarly, reduction of HE to grade 0, 1 usually permits discharge from the hospital and management as an outpatient, reducing exposure to antibiotic-resistant organisms in hospitals and 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 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 (e.g., 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.
According to the American Liver Foundation, liver disease is among the top seven 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 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.
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 bio- artificial 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-QSB, 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.
CONTACT: Investor Relations, Lisa Wilson, +1-212-759-3929, or Media, Doug
MacDougall, +1-781-235-3060, for Arbios; or Shawn Cain, President and CEO,
+1-781-839-7292, or Scott Hayashi, CFO, +1-626-356-3105, both of Arbios
Web site: http://www.arbios.com/