Arbios Systems, Inc.
(OTC Bulletin Board: ABOS), 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 further favorable, preliminary results following the
enrollment of 15 patients in the feasibility clinical trial of its
SEPET(TM) Liver Assist Device. This single arm, uncontrolled study is being
conducted in major liver transplant hospitals under a U.S. Food and Drug
Administration (FDA) Investigational Device Exemption (IDE).
Continued high, rapid rates of disease response have been observed in
the SEPET(TM) treatments thus far, involving reversal of hepatic
encephalopathy (also known as liver coma) associated with acute episodes of
liver failure in patients with chronic liver disease and advanced
cirrhosis. In addition, Arbios has continued to observe a favorable device
safety profile in the SEPET(TM) treatments.
"Preliminary results from this first clinical trial of our SEPET(TM)
Liver Assist Device continue to exceed our expectations in terms of disease
response and tolerability, including some dramatic individual patient
responses to treatment," commented Walter Ogier, President and Chief
Executive Officer of Arbios. "Although very encouraging to both us and our
clinical investigators, we must underscore that these data are preliminary
and need to be confirmed through further data quality assurance and then
proven in a controlled, randomized clinical trial. We are using these data
as the foundation for developing a pivotal clinical trial of SEPET(TM) and
hope to meet with FDA in the next several months to discuss design of the
trial."
The SEPET(TM) feasibility study has so far enrolled patients suffering
hepatic encephalopathy ranging from Grade 2 (characterized by pronounced
lethargy and loss of muscle motor control) to Grade 3 (inability to remain
awake) to Grade 4 (coma). The majority of patients in the study have had
Grade 3 encephalopathy at the outset of treatment, and patients have been
provided up to four, sequential, daily SEPET(TM) treatments, generally
until they achieved a durable, stable disease response. Preliminary
analysis of the clinical trial results indicates an approximate 70% overall
response rate (reduction of encephalopathy by at least two grades) with
another approximately 20% of patients achieving a partial response
(reduction of encephalopathy by one grade). In addition, the clinical
responses were generally observed within 48 hours after initiation of
treatment with many occurring during the 5-6 hours of the first treatment,
and improved overall liver function was documented as determined by
biochemical measures. Treatment was halted prior to achievement of stable
response in three of the 15 patients enrolled (one related to bleeding risk
likely caused by use of heparin for anticoagulation and two related to
repeated malfunction of a dialysis machine).
Just one out of the 15 patients enrolled proved refractory to repeated
SEPET(TM) treatment, achieving only a one-grade improvement in their
encephalopathy. Two severe adverse events likely associated with SEPET(TM)
treatment have been reported to date, including one incident of mild
bleeding likely associated with use of heparin for anticoagulation and one
incident of transient moderate decline in blood platelets count. Both types
of events are expected in extracorporeal therapy procedures, and both were
treated and resolved satisfactorily. FDA has recently allowed discretionary
substitution of an alternative anticoagulation method, utilizing sodium
citrate instead of heparin, meant to reduce bleeding risk in future
treatments.
About the SEPET(TM) Liver Assist Device
The SEPET(TM) Liver Assist Device is a sterile, disposable cartridge
containing microporous hollow fibers with unique 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 (i.e.,
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. SEPET(TM) is currently being
evaluated in a feasibility clinical trial approved for enrollment of up to
20 patients to assess the safety and tolerability of the SEPET(TM) Liver
Assist Device as well as its preliminary effectiveness. Current clinical
sites for the trial include Albert Einstein Medical Center in Philadelphia,
Cedars Sinai Medical Center in Los Angeles, the University of California at
San Diego (UCSD) Medical Center, and the University of California at San
Francisco (UCSF) Medical Center.
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 bioartificial liver that combines blood detoxification with liver
cell therapy to replace whole liver function in patients with the most
severe forms of liver failure. Arbios recently announced the in-license of
a portfolio of issued U.S. and pending patents relating to its SEPET(TM)
technology.
This press release contains forward-looking statements, including but
not limited to Statements pertaining to our clinical trial results and
plans to obtain regulatory approval for our product candidates. These
statements 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
data obtained from early clinical trials being predictive of data to be
obtained in later clinical trials, preliminary data from trials being
predictive of final trial results, the protection afforded by patents and
patents applications, the goals and results of clinical trials, compliance
with regulatory requirements, labeling of our products, the need for
subsequent substantial additional financing to complete clinical
development of its product candidates, future markets and demand for the
Arbios' product candidates, our ability to successfully market our product
candidates and technologies, and our ability to maintain relationships with
key employees, consultants and advisors. 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. 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 for a description of
risks that may affect our results or business conditions. Arbios 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.
Arbios Systems, Inc.
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