Press Release
FOR IMMEDIATE RELEASE
Vital
Therapies Receives FDA Guidance Allowing for the Shipment
of ELAD® Liver Assist System Cartridges to
China
San
Diego, January 4, 2006 - Vital
Therapies, Inc. (VTI) announced today that it has received
guidance from the United States Food and Drug
Administration (FDA) that will allow the Company to begin
Shipment of its ELAD®(Extracorporeal Liver Assist Device)
cartidges to China. Allowance to ship the cartridges was
the final step required for pivotal clinical trials of the
ELAD to begin in China in early 2006. VTI plans to confirm
ELAD's safety and efficacy in these trails, which will
serve as the basis for China approval and launch.
Liver disease is endemic in China, causes more than
400,000 deaths annually. If approved, the ELAD will be the
first ever human cell-based support therapy for liver
failure.
"Liver disease is a major medical problem in China, and
there's an overwhelming and unmet need for new therapies,
said Duan Zhong-Ping MD, professor of Beijing Artificaial
Liver Treatment & Training Center and vice president,
Beijing YouAn Hospital. "I see many patients in our
hospital every month whose lives are threatened by liver
disease, and a good percentage of these die even with the
mechancial artifical liver treatment available here today.
We desperately need a new option that willl provide
metablolic function and allow time for patients' livers to
recover or regenerate."
The ELAD system provides important metabolic support for
patients with severe liver failure, thereby enabling a
bridge to recovery or transplant depending on the type and
severity of liver failure. The system is made up of four
cartiridges containing cells that function like a normal
human liver by metabolizing toxins and removing waste
products while delivering essential proteins back into the
plasma. These cartridges are incorporated into a
blood-pumping system at the patient's bedside and enable
continuous patient treatment for up to 12 days. The key to
the performance of ELAD is its utiization of a proprietary
human hepatocyte cell line, C3A, an immortailed cell line
that can be grown, stored and shipped worldwide.
"According to the World Health Organization (WHO), liver
failure affects approximately 12 million patients
worldwide. In China, hepatitis is the third most prevalent
disease and 20 million people have active viral liver
disease. Official estimates suggest that China's yearly
medical expenses for liver disease total more than $12
billion.
“FDA allowance to export the cartridges made at our San
Diego plant was the final regulatory hurdle we needed to
overcome in order to start treating patients in our pivotal
clinical trial in China,” said Terry Winters, Ph.D.,
chairman and CEO of VTI. “Personnel are now being trained
and cartridges manufactured so we can begin patient
treatment early in 2006.”
Dr. Winters also announced the appointment of Kent Lam as
CEO of VTI, China, Vital Therapies’ China subsidiary in
Beijing. “We are delighted to have Kent in place to run
VTI’s China operation,” said Winters. “He has been
associated with the ELAD project for many years and is well
known to us as an astute businessman with excellent
experience in the medical field. He is well suited to the
challenge of building VTI’s business in China after we
obtain regulatory approval from the SFDA.”
VTI recently completed private equity financing in the
United States, raising $9 million to fund further clinical
studies. The Company has already conducted Phase 1 and 2
clinical trials with ELAD in the United States and the
United Kingdom.
– end –
About Vital Therapies. Inc.
Vital Therapies, Inc. (VTI) is a San Diego-based liver
therapy company. VTI is developing the first human-liver
cell-based system, ELAD® (Extracorporeal Liver Assist
Device), which provides important metabolic support for
patients with severe liver failure.
CONTACTS:
Investors:
Aron Stem
Vital Therapies, Inc.
858-673-6840
Email:
astern@vitaltherapies.com
MEDIA:
Kelly McKenna
MS&L
415-254-6239
Email:
kelly.mckenna@mslpr.com
