Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device
May 12 2008 - 9:03AM
PR Newswire (US)
WALTHAM, Mass., May 12 /PRNewswire-FirstCall/ -- Arbios Systems,
Inc. (OTC:ABOS) (BULLETIN BOARD: ABOS) announced today that the
Company has received 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) liver assist device for blood
purification of acutely ill patients suffering from chronic liver
disease. "We are pleased to have received FDA approval to start the
SEPET pivotal trial and to have fully satisfied the points
addressed in the FDA's previously issued conditional approval,"
commented CEO and President Shawn Cain. "We were pleased with the
compelling results from the SEPET feasibility trial, and we are
excited to initiate the pivotal clinical phase of SEPET's
development. The pivotal trial design includes adaptive measures to
optimize our ability to achieve the trial's primary and secondary
endpoints. We believe that the pivotal trial, if successful, should
support our filing for approval of SEPET in the United States and
marketing efforts in the United States and the European Union.
Further, we believe that the design of this trial will enhance
physician acceptance of SEPET as a much needed tool in sustaining
patients through acute life threatening episodes of liver failure,
a market which we believe exceeds a billion dollars annually."
Trial Design There are three segments to the pivotal trial design.
During the first segment of the trial, 5 non-randomized patients
will be treated with SEPET to allow us to validate the patient
selection criteria, clinical protocol, case report forms, and other
trial related documents. During the second segment of the trial, we
expect to enroll 116 patients in this randomized, controlled phase
of the trial. This segment is targeted to achieve the co-primary
endpoints, which are 1) the percentage of patients achieving
improvement in hepatic encephalopathy ("HE") grade by a minimum of
two grades by the end of Day 7 in the SEPET treatment group versus
the standard medical care group, using a 1:1 randomization between
the two groups; and 2) the 30-day transplant free survival rate in
all patients (i.e. control and treatment groups) who do reach a two
grade HE improvement versus all patients who do not reach a two
grade HE improvement. Pending review and approval by the Data
Safety Monitoring Board, the third segment would permit the size of
the trial to be increased by an additional 52 patients, if the
co-primary efficacy endpoints are reached or have not reached
statistical significance but have shown a positive trend. If the
co-primary endpoints of the trial are reached upon completion of
segment two, extension of the trial into segment three may result
in the achievement of statistical significance of one or more
secondary endpoints of the trial relating to clinical, functional,
and reimbursement advantages for SEPET treatment over standard
medical care. Patient Inclusion/Exclusion Criteria for the Trial To
be a candidate for the pivotal trial, a patient must have chronic
liver disease and be experiencing an acute episode that results in
hospitalization with an HE grade of between II and IV. In addition,
the patient must not be responding satisfactorily to standard
medical care (e.g. fluid replacement, antibiotics, lactulose) for
20 to 26 hours prior to randomization. Patients contraindicated for
a liver transplant (e.g. advanced liver cancer patients and
drinking alcoholics) are excluded from the trial. "We hope to
shortly receive permission from the German regulatory authority to
begin segment one of the pivotal trial at one or two clinical sites
in Germany," commented Mr. Cain. "Over the next several months we
will also seek IRB approvals for up to 24 clinical sites in the
United States and Europe. While we currently have very limited
financial resources, we hope that the FDA's approval to initiate
the pivotal trial may enable us to raise the capital needed to
implement our clinical and regulatory plans for SEPET." 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, including, but not limited to,
statements regarding the Company's belief that, the pivotal trial,
if successful, should support approval of SEPET in the United
States and marketing efforts in the United States and the European
Union, the Company's expectations with respect to the timing,
design and implementation of the pivotal trial, including the
Company's plans with respect to seeking approvals for sites to
conduct the pivotal trial, and the Company's hope that the FDA's
approval to initiate the pivotal trial, may enable us to raise the
capital needed to implement our clinical and regulatory plans for
SEPET. The forward- looking statements contained in this press
release 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 Company's ability to timely and
successfully raise capital, the goals and results of clinical
trials, compliance with regulatory requirements, the likelihood of
obtaining marketing approval, 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, 2007, 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:
Shawn Cain, President and CEO, +1-781-839-7292, Scott Hayashi, CFO,
+1-626-356-3105, both of Arbios; Investors, Lisa Wilson,
+1-212-759-3929; Media, Doug MacDougall, +1-781-235-3060 Web site:
http://www.arbios.com/
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