Arbios Systems, Inc. To Test New Platform For Its Bioartificial Liver
"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.