Press Releases
ARBIOS SYSTEMS, INC. TO TEST NEW PLATFORM FOR ITS BIOARTIFICIAL LIVER
Los Angeles - - December 28, 2004 -- Arbios Systems, Inc. (OTC BB: ABOS), a biomedical device company with proprietary liver assist technologies useful in the treatment of liver failure, announced today that it will test the PERFORMERTM in 2005 as the blood perfusion machine (platform) providing therapy using the proprietary bioartificial liver (BAL) that it is developing. The PERFORMER is a multi-function integrated system capable of supporting extracorporeal (outside the body) blood/plasma/fluid circulation therapies. The use of the PERFORMER for bioartificial liver therapy has previously been validated in clinical studies performed in Europe by RanD S.r.l.; the company that developed the PERFORMER. In order to enable the PERFORMER to be used with Arbios' bioartificial liver, RanD has equipped the PERFORMER with proprietary software and a tubing set specifically designed for use with Arbios' BAL. Arbios' BAL single use extracorporeal liver therapy device consists of porcine (pig) liver cells supplemented by a detoxification column filled with charcoal particles. Since Arbios' BAL requires functions outside of the body, it has to be attached to a perfusion and circulation device such as the PERFORMER.
"We are very pleased that this state-of-the art machine will be tested as the platform for our BAL," commented Dr. Jacek Rozga, Arbios' President and Chief Scientific Officer. "Arbios is designing a Phase III clinical study using our BAL therapy, and we believe that the incorporation of the PERFORMER as the blood perfusion device provides a major enhancement to our technology."
In April 2004, Arbios acquired certain bioartificial liver assets of Circe Biomedical, Inc. ("Circe"), including its intellectual property portfolio, rights to a first-generation bioartificial liver (HepatAssist) and other related liver assist technologies. HepatAssist was tested by Circe in 171 liver failure patients in a Phase II/III prospective, randomized, controlled trial in 11 U.S. and 9 European medical centers. This trial demonstrated that patients with fulminant and subfulminant hepatic failure, (i.e. not chronic diseased patients but rather patients who are stricken for the first time with liver failure) treated with the HepatAssist had a statistically significant survival advantage compared to controls receiving standard medical care. HepatAssist also demonstrated a favorable safety profile. Circe's HepatAssist is based on a BAL technology platform that was developed by the founders of Arbios, Drs. A. A. Demetriou and J. Rozga. The technology was licensed from Cedars-Sinai Medical Center in Los Angeles, CA, to W.R. Grace & Co. who eventually transferred the technology to Circe. The original HepatAssist BAL did not use the PERFORMER as its platform, and it used less pig liver cells than Arbios' current device.
"We are optimistic that our new BAL system, which will have 15 billion pig liver cells rather than the 5 billion cells in the previous version of the product, and a more user-friendly platform, will be even more effective in providing liver-specific therapy than the first-generation device (HepatAssist)," added Dr. Rozga. "With these technological enhancements, we hope to expedite the development of cell-based BAL therapy, revolutionize the way liver failure patients are treated and increase their chances of survival."
While major advances have been made in general supportive treatment and critical care, no direct treatment for liver failure is available and such patients must receive a liver transplant or endure prolonged hospitalization with significant mortality. However, only a small percentage of liver failure patients receive a transplant due to the shortage of donor livers. Furthermore, many patients cannot be transplanted because of alcohol or drug abuse, infection, cancer or cardiovascular disease. There is definitely a clinical need for artificial means of liver assistance to facilitate recovery from liver failure without a transplant.
The American Liver Foundation estimates that 25,000,000 Americans are or have been suffering from liver and biliary diseases. According to the National Center For Health Statistics published for 2000, there were 360,000 hospital discharges for patients with chronic liver disease or cirrhosis. Of those, 27,035 died (10th leading cause of death in males and 12th in females; 4th cause of death in persons aged 45-54 years) because no donor liver was found or because they had contraindications to transplantation. During 2001 alone, 12,207 people died in the United States due to alcoholic liver disease and 10,652 individuals died as a consequence of other diseases of the liver (inflammatory, drug-induced, acute hepatitis, unspecified, hepatitis B, etc.). Approximately 3.9 million Americans are already chronically infected with the hepatitis C virus and an estimated 25,000 people are additionally infected each year with the hepatitis C virus. At the same time, 10,000-12,000 deaths occur annually due to hepatitis C virus infection. Hepatic decompensation/failure, as a result of chronic hepatitis C virus infection, is the leading cause of liver transplantation.
About Arbios
Arbios Systems, Inc. is a biomedical device company that, through its wholly-owned subsidiary, Arbios Technologies, Inc., is engaged in the discovery, acquisition and development of proprietary liver assist devices and new technologies useful in the diagnosis and treatment of acute liver failure. Arbios' two lead products in development include SEPET™, a novel blood purification therapy employing selective plasma exchange and a second-generation BAL (HepatAssist-2™), in which liver cell therapy and sorbent-based plasma filtration are integrated in a proprietary BAL system. Arbios estimates that more than 200,000 extracorporeal liver support treatments may be needed annually in the United States alone to help keep liver failure patients alive until either an organ becomes available for transplantation or the native liver recovers from injury. The Company believes that the BAL HepatAssist-2TM and SEPET™ may address this demand.
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 ability of Arbios to complete the development of its products, the uncertainty related to the results of the clinical tests to be conducted by the company, including the tests with the PERFORMER, 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. 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. SEPET™ and HepatAssist-2™ are trademarks of Arbios Technologies, Inc., the subsidiary of Arbios Systems, Inc.
