MOUNTAIN VIEW, Calif., Feb. 24 /PR Newswire/ -- Aviron (Nasdaq: AVIR)
announced today positive results of a clinical trial intended to demonstrate
consistency of manufacture for the Company's intranasal influenza vaccine.
Evidence that different lots of vaccine can be manufactured at a consistent
quality level is required by the US Food and Drug Administration (FDA) prior
to approval of biological products for commercial sale. Aviron intends to
file its FDA application for this product in mid-1998.
The results announced today are from a randomized, double-blind,
placebo-controlled trial in 500 young children, designed to evaluate the
safety and immunogenicity of three new manufacturing lots of Aviron's cold
adapted influenza vaccine. Children were vaccinated between April and
September, 1997. The study was performed by Joel Ward, MD, and Ken Zangwill,
MD, at the UCLA Center for Vaccine Research. Preliminary analysis of patient
diary cards and antibody responses following two doses of the vaccine showed
consistent safety and immunogenicity responses for the different lots.
The lots of vaccine used for the trial were manufactured for Aviron by
Evans Medical, a subsidiary of Medeva PLC (NYSE: MDV), at its Speke facility
in the UK, and formulated to match the strains recommended by the FDA for the
1997-1998 injectible influenza vaccine. This study also compared the safety
and immunogenicity of these manufacturing lots to the vaccine used in Aviron's
1996-1997 phase III pivotal trial in children.
"In addition to fulfilling a significant milestone in the critical path
towards our FDA application this year, these results mark the continuing
success of our manufacturing collaboration with Evans Medical, who have
produced vaccine throughout our clinical trial program and are preparing to
make vaccine for our commercial launch after FDA approval," said J. Leighton
Read, MD, Chairman and CEO of Aviron.
Aviron and the Division of Microbiology and Infectious Disease (DMID) of
the National Institute of Allergy and Infectious Diseases (NIAID) are
conducting clinical trials as part of a Cooperative Research and Development
Agreement (CRADA) in numerous sites across the United States.
Aviron is an emerging biopharmaceutical company based in Mountain View,
California whose strategy is to focus on the prevention of disease. The
Company's goal is to develop vaccines to prevent a wide range of viral
infections that affect the general population, providing a cost-effective
means of addressing a number of major diseases. The majority of the Company's
products under development are live vaccines against viral infections,
including influenza, parainfluenza (PIV-3), cytomegalovirus (CMV), genital
herpes (HSV-2) and respiratory syncytial virus (RSV).
This press release contains forward-looking statements. Actual results
may differ materially from those suggested here. Additional information
concerning factors that could cause such a difference is contained in Aviron's
Prospectus dated August 13, 1997.
SOURCE Aviron
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CONTACT: media, John Bluth of Fleishman-Hillard, 212-453-2429, for Aviron; or investors, J. Leighton Read, M.D., or Fred Kurland, of Aviron, 650-919-6500
CNOC: http://www.prnewswire.com or fax, 800-758-5804, ext. 114000
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