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News

Arbios receives conditional FDA approval to begin clinical trial for an artificial liver assist device

Arbios Systems : 25 February, 2008  (New Product)
Arbios Systems has received conditional approval from the US Food and Drug Administration of an Investigational Device Exemption (IDE) to begin the pivotal clinical trial for Sepet, Arbios' extracorporeal (outside the body) artificial liver assist device for blood purification of chronically ill patients suffering from acute liver failure.
Permission was granted to initiate the trial while the company responds to the FDA's conditions and request for additional information. In particular, FDA has requested a survival primary endpoint, which could potentially increase the total number of patients required for the trial.

The trial design proposed by the company has a primary endpoint of a two-stage drop in hepatic encephalopathy and its secondary endpoints include several survival based endpoints. The company is refining its position that a two-stage drop in hepatic encephalopathy is clinically meaningful and an appropriate primary endpoint for the trial. The company is requesting a meeting with FDA to discuss this issue and to confirm the overall design of the trial.

'While we are pleased to have received FDA permission to start the SEPET pivotal trial, we will work diligently with FDA with the hope of identifying a mutually acceptable primary endpoint,' commented chief executive officer and resident Shawn Cain. 'We currently do not have the financial resources to fund the pivotal trial and our ability to finance the company is contingent upon, among other issues, agreement on a primary endpoint with a reasonable number of patients required for the trial.'

'Hepatic encephalopathy (HE) represents one of the most frequent complications of cirrhosis mandating hospitalisation and a two-stage improvement of HE has significant clinical benefits to patients,' noted Dr John Vierling, MD FACP chairman of Arbios and professor of medicine and surgery and chief of hepatology at the Baylor College of Medicine. 'Specifically, patients with grade 3 or 4 HE are intubated in the intensive care unit (ICU) to prevent lethal aspiration pneumonia and can be transferred out of the ICU after a reduction of 2 grades of HE, unless other complications require continued ICU care. Similarly, reduction of HE to grade 0, 1 usually permits discharge from the hospital and management as an outpatient, reducing exposure to antibiotic-resistant organisms in hospitals and eliminating risks associated with medical errors.'
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