Further Analysis to Be Presented at Fall Scientific Meeting
MOUNTAIN VIEW, Calif., Aug. 3 /PRNewswire/ -- Aviron (Nasdaq: AVIR)
announced today a preliminary analysis of the second year of a two-year study
of 1358 children during the 1997-98 flu season with FluMist(TM), the company's
intranasal influenza vaccine. The preliminary analysis indicated that FluMist
provided protection against culture-confirmed influenza, even though the
predominant strain of influenza circulating during last year's flu season,
A/Sydney, was not included in last year's flu vaccines, including the
preparation of FluMist used in the clinical trial.
This past flu season, children involved in a pivotal phase 3 trial in the
1996-1997 flu season were invited to participate in a follow-up trial.
Children were vaccinated with a single dose of FluMist(TM) formulated to match
the 1997-1998 flu shot or placebo. Investigators were evaluating study
participants to test the safety and efficacy of vaccination in subsequent flu
seasons.
Final data are currently being analyzed and investigators expect to
present the results at the Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC), September 24 - 27, in San Diego.
Results from the year-one study (1996-97 flu season) showed only one
percent (14 of 1070) of the children who received FluMist developed
culture-confirmed influenza, versus 18 percent (95 of 532) of the children who
received placebo -- a protection rate of 93 percent.
This trial was conducted under a Collaborative Research and Development
Agreement (CRADA) between Aviron and the National Institute of Allergy and
Infectious Diseases (NIAID) of the National Institutes of Health (NIH). It
involved ten sites nationwide, including six Vaccine and Treatment Evaluation
Units (VTEUs) supported by NIAID and four sites supported by Aviron.
The National Institute of Allergy and Infectious Diseases, a division of
the National Institutes of Health, conducts and supports research to prevent,
diagnose, and treat infectious and immunologic diseases. NIAID has a major
responsibility within the federal government for developing vaccines to
control and prevent infectious and immunologic diseases. NIH is an agency of
the U.S. Department of Health and Human Services.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease. The company's goal is developing vaccines 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. FluMist(TM) is currently under review
by the US Food and Drug Administration. Products in clinical development
include parainfluenza (PIV-3) and in collaboration with SmithKline Beecham
Biologicals, a subunit vaccine against Epstein-Barr Virus (EBV) infection, a
major cause of infectious mononucleosis. Products in pre-clinical development
include vaccines for respiratory syncytial virus (RSV), cytomegalovirus (CMV)
and genital herpes (HSV-2).
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
Annual Report on Form 10-K for the year ended December 31, 1997.
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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Related links:
http://www.aviron.com
Company News On-Call: http://www.prnewswire.com or
fax, 800-758-5804, ext. 114000
CONTACT:
media, Karen Gilbert, 650-919-6578, or
investors, Lyn Christenson, 650-919-3716, both of Aviron; or John
Bluth, or Louise Leavitt, of Fleishman-Hillard, 212-453-2000, for
Aviron
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