Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)
February 22 2008 - 2:27PM
PR Newswire (US)
Primary Endpoint of the Trial to Be Clarified with FDA WALTHAM,
Mass., Feb. 22 /PRNewswire-FirstCall/ -- Arbios Systems, Inc.
(OTC:ABOS) (BULLETIN BOARD: ABOS) 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. DATASOURCE: 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 Systems, Inc. Web site: http://www.arbios.com/
Copyright