Arbios Systems Reports Favorable Results From the SEPET(TM) Feasibility Clinical Trial
April 03 2007 - 9:30AM
PR Newswire (US)
High Rates of Disease Response and Favorable Safety Profile
Observed with 15 Patients Enrolled WALTHAM, Mass., April 3
/PRNewswire-FirstCall/ -- Arbios Systems, Inc. (OTC:ABOS) (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. DATASOURCE: Arbios Systems, Inc. CONTACT: Walter C. Ogier,
President and CEO of Arbios Systems, Inc., +1-781-839-7293; or Doug
MacDougall of MacDougall Biomedical Communications,
+1-508-647-0209, for Arbios Systems, Inc. Web site:
http://www.arbios.com/
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