Arbios Systems Publishes Positive Results From Completed Sepet(TM) Feasibility Clinical Trial
September 07 2007 - 8:45AM
PR Newswire (US)
Results to be Presented at the 9th International Symposium on
Albumin Dialysis in Liver Disease (ISAD) and the Annual Meeting of
the European Society for Artificial Organs (ESAO) WALTHAM, Mass.,
Sept. 07 /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 positive results from the completed
feasibility clinical trial of its SEPET(TM) Liver Assist Device, in
which 79% of patients met the primary clinical effectiveness
endpoint. The results will be published tomorrow at the 9th
International Symposium on Albumin Dialysis in Liver Disease (ISAD)
as a research abstract authored by Fred Poordad, MD, Chief of
Hepatology and Liver Transplantation at Cedars-Sinai Medical
Center, Los Angeles, CA, a Principal Investigator in the clinical
trial, and other study participants. In addition, Jacek Rozga, MD,
Ph.D., Chief Scientific Officer and Founder of Arbios Systems, Inc.
and a co-author of the abstract, will deliver an oral presentation
of the clinical trial results tomorrow at the ISAD medical
conference, being held in Warnemunde, Germany. He also previewed
the results yesterday in a scheduled oral presentation at the
Annual Meeting of the European Society for Artificial Organs (ESAO)
in Krems, Austria. Arbios' SEPET(TM) Liver Assist Device is a novel
large-pore blood filter that is being studied in chronic liver
disease patients for its potential to promote improvements in liver
function following acute exacerbation of liver failure, through its
ability to selectively reduce the level of circulating toxins of
hepatic failure as well as inflammatory mediators and inhibitors of
liver regeneration. According to the American Liver Foundation,
chronic liver disease is the tenth leading cause of death in the
United States, resulting in approximately $10 billion in annual
healthcare costs. 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. "We are pleased that the final results of our
SEPET(TM) feasibility trial appear to have confirmed the safety and
tolerability of the device and are particularly excited at the
achievement of unusually rapid clinical responses in most patients,
many within the first hours of treatment," commented Walter Ogier,
President and Chief Executive Officer of Arbios. "The successful
completion of this study serves as the foundation for developing an
appropriately powered, randomized, controlled pivotal clinical
trial of SEPET(TM) and we look forward to continuing to work with
the FDA in the near- term to secure allowance to proceed with this
important trial. The excellent final results of the feasibility
trial, and their acceptance for oral presentation at the ISAD
conference, also give us further confidence in seeking potential
earlier commercialization of the SEPET(TM) device in Europe under
the CE Mark." "Chronic liver failure represents a significant unmet
need, as patients often rapidly decline while waiting to undergo or
become eligible for liver transplant surgery and this problem is
exacerbated by a shortage of livers. Furthermore, a large majority
of patients do not have the option of receiving a transplant,"
commented Dr. Rozga. "The results from this feasibility study,
representing clinical outcomes data that have now been fully
monitored and analyzed, strongly support further clinical trials of
the SEPET(TM) liver assist device, including a pivotal clinical
trial leading to product registration in the US. I am excited that
SEPET(TM) may become a viable option to serve as a bridge therapy
for healing and regeneration of livers as well as a potential
bridge to successful liver transplantation in eligible patients."
This single arm, uncontrolled SEPET(TM) feasibility study was
conducted in 15 patients at three major liver transplant hospitals
(Cedars Sinai Medical Center, Los Angeles; Albert Einstein Medical
Center, Philadelphia; and University of California Medical Center,
San Diego) under a U.S. Food and Drug Administration (FDA)
Investigational Device Exemption (IDE). The study enrolled patients
suffering hepatic encephalopathy (HE) (also known as liver coma)
ranging from Grade 1 to Grade 3. Fourteen patients were treated
with at least one typically 5 -- 6 hour round of SEPET(TM)
treatment, receiving an average of less than two, and a maximum of
four, sequential daily treatments until a stable, durable disease
response was achieved. Final analysis of the clinical trial results
confirmed a high rate of achievement of the primary endpoint for
clinical effectiveness with 11/14 (79%) subjects showing full
resolution or a reduction in HE by at least two grades. The
responses were generally rapid and observed within 48 hours after
initiation of treatment, with many occurring during the first
treatment. 13/14 (93%) patients' responses were sustained over the
30-day follow-up period, and improved overall liver function was
documented as determined by biochemical measures. Just one out of
the 14 patients treated proved refractory to repeated SEPET(TM)
treatment, however achieving a single-grade improvement in their
encephalopathy. Two additional patients had treatment halted early,
prior to achievement of stable response, due in one case to mild
bleeding at a catheterization site and in the other to malfunction
of a (non-Arbios) dialysis machine. All patients survived until the
end of the 30-day follow-up period and 3 patients were subsequently
transplanted with a donor liver. SEPET(TM) treatment was generally
well-tolerated and had no negative effects on vital signs (heart
rate, blood pressure and respiration) and base blood chemistries.
Expected moderate reductions in blood platelets were observed, none
with critical consequence. An adverse event of renewed, mild
bleeding from a site of prior recent trauma, categorized as severe,
was not associated with a low platelet count and was likely caused
by the use of heparin for anticoagulation, which is commonly
utilized in extracorporeal blood therapy. All treatment-related
adverse events were expected and typical of extracorporeal blood
therapy procedures, and all were resolved satisfactorily with
indicated treatment. FDA has allowed a SEPET(TM) protocol amendment
involving discretionary substitution of an alternative
anticoagulation method, utilizing sodium citrate instead of
heparin, which is anticipated to reduce bleeding risk in subsequent
treatments. About the 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 (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. 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. 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-Q, 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:
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 Web site: http://www.arbios.com/
Copyright