MOUNTAIN VIEW, Calif., Aug. 11 /PRNewswire/ -- Aviron (Nasdaq: AVIR)
announced today the completion of a Phase 1 clinical trial of an
investigational vaccine against Epstein-Barr Virus (EBV), performed under its
collaboration with SmithKline Beecham Biologicals. The study showed that the
vaccine tested was safe and well-tolerated whether or not subjects had been
exposed to EBV prior to the study. Although the study was not designed to
evaluate the efficacy of the vaccine, laboratory tests showed evidence of
immune response in vaccine recipients.
The trial was a randomized, double-blind study to evaluate safety and
immunogenicity of two formulations of intramuscularly injected vaccines in
healthy young adults. It was conducted at University Hospital of Liege,
Belgium. The vaccine was administered to 67 subjects. The vaccine under
development is based on the single surface antigen responsible for most of the
neutralizing antibodies stimulated by EBV infection, and combines Aviron's
antigen with SmithKline's proprietary adjuvant technology.
Epstein-Barr Virus belongs to the herpesvirus family and is the major
cause of infectious mononucleosis. Mononucleosis affects an estimated
250,000 young adults in the U.S. and Europe annually. Sore throat and swollen
neck glands are followed by a period of fatigue and lethargy which can last
for weeks or months, and dramatic enlargement of the liver and spleen may
require avoidance of many sports activities.
"We are pleased with the results of this first clinical trial, which was a
major step forward for one of Aviron's initial vaccine programs," said
J. Leighton Read, M.D., Aviron Chairman and Chief Executive Officer. "In
addition to infectious mononucleosis, Epstein-Barr Virus is also implicated as
a contributing cause of lymphomas and other cancers in humans. An effective
vaccine could provide an important public health benefit.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease. The company's goal is to develop products which
offer cost-effective prevention of a wide range of infections that affect the
general population. The majority of Aviron's products under development are
live vaccines against viral infections. These include intranasal vaccines
under development for respiratory infections and their complications
-- influenza, parainfluenza (PIV-3), and respiratory syncytial virus (RSV),
and injectable vaccines to prevent cytomegalovirus (CMV) and genital herpes
(HSV-2).
SmithKline Beecham Biologicals is located in Rixensart, Belgium, and is
the centre of all SB's activities in the field of vaccine research,
development and production. SB Biologicals employs over 600 research
scientists who are devoted to discovering new vaccines and developing more
cost-effective and convenient combination products to prevent infections which
cause serious medical problems worldwide. SB produces 700 million doses of
vaccines per year for the developing and developed world. Every second,
20 doses of SB Bio vaccines are distributed around the world. SmithKline
Beecham -- one of the world's leading healthcare companies -- discovers,
develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter
medicines and health-related consumer products, and provides healthcare
services including clinical laboratory testing and disease management.
This press release contains forward-looking statements. Actual results
may differ materially from those suggested here. Factors that could cause
actual results to differ include, but are not limited to, failure in a
clinical trial, failure to demonstrate stability or failure in the
manufacturing process. Additional information concerning factors that could
cause such a difference is contained in Aviron's Annual Report on Form 10-K
for the year ended December 31, 1998.
To receive an index and copies of recent press releases, call Aviron's
News-On-Call toll-free fax service, 800-758-5804, extension 114000.
Additional information about the company can be located at
http://www.aviron.com.
SOURCE Aviron
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CONTACT:
media, Karen Gilbert of Aviron, 650-919-6578;
or Louise Leavitt of Fleishman-Hillard, 212-453-2000, for Aviron;
or investors, Fred Kurland of Aviron, 650-919-6666
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