Navigation Links
Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)
Date:2/22/2008

Primary Endpoint of the Trial to Be Clarified with FDA

WALTHAM, Mass., Feb. 22 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. (OTC Bulletin Board: ABOS) announced today that the Company has received conditional 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) 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 CEO and President 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 hospitalization and a two-stage improvement of HE has significant clinical benefits to patients," noted Dr. John Vierling, M.D. 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," further commented Dr. Vierling.

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 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-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.


'/>"/>
SOURCE Arbios Systems, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
7. CryoCor Receives FDA Approval for Right Atrial Flutter
8. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
9. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
10. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
11. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... CHEYENNE, Wyoming , Feb. 24, 2017  Xynomic ... company, today announced that it has acquired exclusive ... a potentially best-in-class innovative HDAC inhibitor targeting hematological ... total of 14 Phase 1 and 2 clinical ... Asia have already been completed, ...
(Date:2/23/2017)... -- Genesis Healthcare Services has merged with Hospice Cloud, a ... Bill Monast , President and CEO of Hospice Cloud ... , executives with Home Health Depot, Inc., the parent ... This acquisition helps Hospice Cloud maintain its position as ... equipment (DME) solutions for the hospice industry. Nathan ...
(Date:2/23/2017)... Nevro Corp. (NYSE: NVRO), a global medical device ... of chronic pain, today reported financial results for the three ... 2016 Accomplishment & Highlights: Achieved revenue ... of 228% as reported, over the prior year ... 612% over the prior year International revenue ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... Healthcare Associates of McKinney ... at Craig Ranch building at 8080 State Highway 121, Suite 210, McKinney, Texas 75070. ... access to Highway 121. , As the practice has grown, the need for more ...
(Date:2/24/2017)... , ... February 24, 2017 , ... The International Association ... annual “Imagine Me Beyond What You See” body image mannequin art competition. Selected from ... be showcased and the winner revealed at the 31st annual iaedp Symposium, March 22 ...
(Date:2/24/2017)... ... 2017 , ... Castle Farms, the celebrated Northern Michigan ... the winning couple announced on Feb. 14, 2017, on Facebook. The free wedding ... A Matter of Taste, Ryan Rousseau Enterprises, A Touch of Spring and Other ...
(Date:2/23/2017)... ... 23, 2017 , ... Rare Disease Report®, which is the ... Rare Disease Day events, hosted by the Rare Disease Legislative Advocates (RDLA) on ... weekly e-newsletter and quarterly publication, will be conducting interviews with patients and advocates ...
(Date:2/23/2017)... , ... February 23, 2017 , ... ... approved content provider for the National Institute for Health and Care Excellence ... care-related organizations in the National Health Service (NHS) to search, order and purchase ...
Breaking Medicine News(10 mins):