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Arbios Receives Conditional Approval From The FDA To Initiate Pivotal Clinical Trial For SEPET(TM)
Arbios Systems, Inc.
(OTC Bulletin Board: ABOS) announced 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.
Arbios Systems, Inc.
http://www.arbios.com
Arbios primeºte condiþionatã de aprobarea de la FDA pentru a iniþia Studiul clinic pivot pentru SEPET (tm) - Arbios Receives Conditional Approval From The FDA To Initiate Pivotal Clinical Trial For SEPET(TM) - articole medicale engleza - startsanatate