ESAO - Liver Support Working Group

HepaWash and II. Medical Department, University Hospital rechts der Isar awarded € 425,000 grant from the Bayerische forschungsstiftung (BFS) for a € 0.9 Mio collaborative Preclinical study on Acute liver Failure

Hepa Wash GmbH (Hepa Wash), a medical device company developing an innovative liver support device announced today that it has received a € 425,000 grant from the Bayerische Forschungsstiftung (BFS) to test the safety and efficacy of its laboratory prototype in a preclinical animal model for acute liver failure in collaboration with the II. Medical Department, University Hospital Rechts der Isar.
The grant will be used to develop an improved animal model for acute liver failure in pigs that resembles much more the clinical situation of acute liver failure in humans than currently available models. This new model will allow to analyzing and evaluating the safety and efficacy of the Hepa Wash® treatment on the function of vital organs during acute liver failure, results that will be very important for the further development and optimization of the Hepa Wash® device. In addition, these data will also be very helpful to gain a better insight into the underlying pathology of acute liver failure, a disease that is still only partially understood.

Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET™

Arbios Systems, Inc., announced that the Company has received conditional approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption to begin the pivotal clinical trial for SEPET™, Arbios’ extracorporeal 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.
More information here.

German Biotechnology Company Survey 2006

Just two decades ago, biotechnology in Germany was taking its first developmental steps in the marketplace. Today, it is firmly established as a commercial branch. This is the picture emerging from the recent national biotechnology survey, taking in biotech companies of all sizes from across Germany, and carried out by biotechnologie.de on behalf of the Federal Ministry for Education and Research (BMBF). For the first time in this sector, the data complies with statistical standards as set by the Organization for Economic Cooperation and Development (OECD), allowing for a reliable and internationally comparable description of the German biotech landscape.

The biotechnology company survey was carried out between January and March 2006. From a total of 657 companies which were requested to participate, 599 completed the survey; a participation ratio of about 91%. The deadline for data to be included was 31.12.2005.

Source: www.biotechnologie.de

Arbios Systems Announces Addition of Senior Personnel

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 the addition of two new senior personnel. Dr. Ulrich Baurmeister, Ph.D., has joined Arbios as Chief Technology Officer with responsibility for further development of proprietary blood separation technology for the Company, and Dr. Jan Stange, M.D., has joined as Senior Clinical Advisor, with responsibility for medical direction of the Company's clinical trials. Dr. Jacek Rozga, M.D., Ph.D., will continue to serve as the Company's Chief Scientific Officer on a part- time basis beginning November 30, 2006. All three individuals will work under retainer consulting agreements with the Company.
Press Release

Small sections of human liver have been created from umbilical cord stem cells

Small sections of human liver have been created from umbilical cord stem cells, say scientists from Newcastle University, UK. The researchers say this technology could eventually be used to grow small livers that could be used for drug tests - doing away with the need for human volunteers to take risks. Earlier this year six volunteers became dangerously ill during a drug trial in the UK.
The scientists warned that it will be tens of years before we are anywhere near producing whole new livers for transplants. However, within the next 15 years, tiny livers could be produced and used for treating patients. Team leaders, Dr. Nico Forraz and Prof. Colin McGuckin, have set up ConoStem, a company aimed at marketing their stem cell research results. Professor McGuckin said "We take the stem cells from the umbilical cord blood and make small mini-livers. We then give them to pharmaceutical companies and they can use them to test new drugs on. It could prevent the situation that happened earlier this year when those six patients had a massive reaction to the drugs they were testing."
The study papers have not yet been peer-reviewed and/or published yet. Dr. Mike Nicholds, CEO, ConoStems, said they are planning to have their studies peer-reviewed. Professor Colin McGuckin and Dr Nico Forraz (pictured), who have formed spin out company ConoStem, beat off competition from staff teams in other universities to win a major regional business plan competition, Blueprint. Conostem has developed ways of growing 3D models of human organs from stem cells for use in drug testing.

Stelic: Specific neutralizing agent for chemokine CXCL10

Stelic Institute & Co., a Tokyo-based bioventure company specializing in regenerative medicine, has announced development of a new treatment method for acute liver failure: The Company's Stem Cell Dynamism Research Team has shown that a protein called chemokine1 CXCL102 directly affects hepatic cells, regulating their replication and proliferation. Research results demonstrated for the first time that hepatic cells possess a mechanism for attempting to repair the wide-ranging hepatic cell necrosis associated with drug-induced acute liver failure, and that anti-CXCL10 antibodies strengthen this type of self-repairing function at the in vivo level.
More information via www.stelic.com

FDA Allows Increased Enrollment for SEPET™ Clinical Trial

Arbios Systems, Inc., a biomedical device and cell therapy company developing proprietary liver assist products for the treatment of liver failure, announced that the US Food and Drug Administration (FDA) has allowed the expansion of the number of clinical sites and increased the allowable number of patients in its IDE feasibility clinical trial for its SEPET™ liver assist device. Under the revised protocol, Arbios can include up to four clinical trial sites and to up to 20 liver failure patients with encephalopathy. The trial was previously limited to two sites and 15 patients. The company further announced that the University of California at San Diego (UCSD) Medical Center will serve as an additional clinical site in the trial. UCSD joins Cedars Sinai Medical Center in Los Angeles and Albert Einstein Medical Center in Philadelphia as authorized clinical sites for this ongoing trial.

Albert Einstein Medical Center Enrolls First Patient in the U.S. in Clinical Trial for SEPET

The Albert Einstein Medical Center in Philadelphia has enrolled the first patient in the United States in a Food & Drug Administration-approved Phase 1 safety trial of the SEPET™ artificial liver support device. Einstein is one of only two institutions in the country selected to participate in the clinical trial, which is designed to assess the safety and efficacy of the technology. The clinical trial will also evaluate the device’s potential as a blood purifier to provide temporary liver support during acute-on-top-of-chronic liver failure and facilitate recovery from liver failure, support liver regeneration, and help keep liver failure patients alive until an organ becomes available for transplantation.

ELAD in China

Vital Therapies, Inc. (VTI) announced today that it has received guidance from the United States Food and Drug Administration (FDA) that will allow the Company to begin shipment of its ELAD(R) (Extracorporeal Liver Assist Device) cartridges to China. Allowance to ship the cartridges was the final step required for pivotal clinical trials of the ELAD to begin in China in early 2006. VTI plans to confirm ELAD's safety and efficacy in these trials, which will serve as the basis for China approval and launch.
SAN DIEGO, Jan. 4 /PRNewswire/

Arbios Systems Presentation at ThinkEquity Partners 3rd Annual Growth Conference to be Webcast Live

LOS ANGELES, Sept. 7 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. (OTC: ABOS - News), a biomedical device company developing proprietary liver assist devices for the treatment of liver failure, today announced that Amy Factor, Chief Executive Officer, will be presenting at the ThinkEquity Partners 3rd Annual Growth Conference on Wednesday, September 14, 2005 at the Ritz Carlton Hotel in San Francisco at 4:00pm Pacific Time (7:00pm Eastern Time).

The presentation will be webcast live and can be accessed through the Company's website at http://www.arbios.com. An archive of the presentation will be available for 90 days.

Arbios Systems, Inc. is a biomedical device company that 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' products in development include SEPET(TM), a novel blood purification therapy and HepatAssist-2(TM), a bioartificial liver combining liver cell therapy and sorbent-based detoxification.