Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
September 25 2007 - 8:02AM
PR Newswire (US)
- Data Sufficient to Advance Product to Pivotal Phase - WALTHAM,
Mass., Sept. 25 /PRNewswire-FirstCall/ -- Arbios Systems, Inc.
(OTC:ABOS) (BULLETIN BOARD: ABOS) , today provided its clinical
trial strategy for the SEPET(TM) Liver Assist Device including
information regarding a pre-pivotal phase meeting with the US Food
and Drug Administration (FDA). In a meeting held between Arbios and
the FDA's Office for Device Evaluation and Research (ODE), the FDA
indicated that, pending receipt of a final report, SEPET(TM) has
met the required feasibility trial objectives and Arbios may
advance its clinical development program to the pivotal phase. In
response to the presentation of a pivotal trial design, the FDA
provided the Company with comment and further indicated that a
single pivotal study may be acceptable to the FDA, subject to a
submission of a full clinical protocol to include additional
information required in an Investigational Device Exemption (IDE)
application. Arbios intends to file this information for review in
the coming weeks, as a potential final step toward FDA
authorization of a pivotal clinical trial for SEPET(TM). "We are
pleased with the discussion at our recent meeting with the FDA
regarding our SEPET(TM) Liver Assist Device," commented Shawn Cain,
Interim President and Chief Executive Officer of Arbios. "Following
the results of our feasibility clinical trial, the FDA review group
said that SEPET(TM) could advance into a multicenter pivotal
clinical trial. We appear to be on track for near-term initiation
of a pivotal registration trial of SEPET(TM) in the US." We expect
the proposed pivotal clinical trial would enroll 80 patients in the
principal randomized, controlled phase of the study, targeted to
achieve the primary endpoint of the trial, which is a clinically
significant reduction in hepatic encephalopathy. Patients receiving
SEPET(TM) treatment plus standard medical care would be compared to
control patients receiving treatment with standard medical care
alone, with 1:1 randomization between the two groups. An adaptive
design feature, increasingly common in FDA product approval trials,
would permit the size of the trial to be increased after enrollment
of the first 80 patients if the primary efficacy endpoint has not
yet reached statistical significance but has shown a positive
trend. A further and final potential extension of the trial would
also be permitted to achieve statistical significance of one or
more secondary endpoints of the trial relating to clinical,
functional, and reimbursement advantages for SEPET(TM)-treated
patients. In parallel with the US-oriented pivotal clinical trial
of the SEPET(TM) Liver Assist Device, Arbios intends to advance the
product toward European market approval under the CE Mark. Arbios
believes that such registration of SEPET(TM) could be accomplished
significantly earlier than registration in the US, because a
randomized, controlled trial is customarily not required under the
European Medical Device Directives. Arbios plans to involve several
leading European medical centers in the pivotal trial, so that the
results of the trial will be relevant to both US and European
patients and may be used to support medical payor (both private
sector and government) coverage in both regions. 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, chronic liver disease is the tenth
leading cause of death in the US, 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. 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, including, but not limited to,
statements regarding the Company's expectations as to the path
forward for the clinical development of SEPET(TM), including the
expected design of the pivotal trial of SEPET(TM). 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, but not limited to, risks or
uncertainties related to the goals and results of clinical trials,
the timing and outcome of the FDA's review of the revised protocol
for the proposed pivotal trial of SEPET(TM), 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: Shawn Cain, Interim
President and CEO, +1-781-839-7292, or Scott Hayashi, CFO,
+1-626-356-3105, both of Arbios Systems, Inc.; or Investor
Relations: Lisa Wilson, +1-212-759-3929, or Media Relations: Doug
MacDougall or Kari Watson, +1-508-647-0209, all for Arbios Systems,
Inc. Web site: http://www.arbios.com/
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