Arbios has recently completed the Phase I Feasibility trial for the SEPET™ Liver Assist Device and is working with FDA to obtain approval to commence the Phase II/III Pivotal clinical trial in 2008.

Summary of Completed Feasibility Trial:

A Phase I Prospective, Longitudinal Feasibility Trial of Safety, Tolerance and Efficacy of SEPET™ in Patients with Acute Exacerbation of Chronic Liver Disease

The Phase I trial was an open-label feasibility study. The primary objective was to assess the safety, tolerability and potential efficacy of a novel liver support therapy (SEPET™). The patient population was comprised of patients between the ages of 18-65 who were admitted to a participating institution with acute exacerbation of chronic liver disease manifested by hepatic encephalopathy (HE). Chronic liver disease may include cirrhosis due to any etiology. All patients who were enrolled in the study received standard medical care (SMC) and a daily 6-hour SEPET™ treatment until either the patient had up to 7 treatments or achieved sustained improvement of hepatic encephalopathy. Seventy-nine (79%) of the patients responded favorably to the clinical endpoint, which was measured by a two stage improvement in hepatic encephalopathy. Comparison of patients' pre and post SEPET™ treatment demonstrated significant improvements in HE (p = 0.0005). Primary and secondary endpoints were achieved with an average of only 1.9 treatments. The results also indicated that the therapy was well tolerated, and demonstrated a favorable safety profile.

The SEPET™ cartridge is a single-use hemofiltration cartridge designed to provide purification of blood from hepatic and renal failure toxins, mediators of inflammation and inhibitors of hepatic regeneration. A standard dialysis system is used as the platform to provide SEPET™ treatment.

Click on the link below to be redirected to a presentation that summarizes the Phase I Feasibility Trial in greater detail:

If you are a clinical site interested in learning more about participating in the upcoming pivotal clinical trial, please contact us directly.

Company Contact
Susan Papalia, R.N. - Vice President of Clinical Affairs
Arbios Systems, Inc.
1050 Winter Street, Suite 100
Waltham, MA 02451
E-mail: spapalia@arbios.com