MOUNTAIN VIEW, Calif., June 30 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced the initiation of clinical testing with its vaccine candidates to
prevent infection with cytomegalovirus (CMV), the leading infectious cause of
birth defects in the United States.
A Phase 1, randomized, double-blind, placebo-controlled trial will
evaluate the safety of four live attenuated injectable vaccine candidates
designed by Aviron scientists. Investigators at the Vaccine Treatment and
Evaluation Unit at Saint Louis University are enrolling 25 healthy adults aged
18-50 who have had previous natural exposure to CMV.
The study is being conducted by the National Institute of Allergy and
Infectious Diseases (NIAID), a component of the National Institutes of Health.
The lead investigator is Thomas Heineman, M.D., Ph.D., assistant professor of
medicine at Saint Louis University.
"Bringing our CMV vaccine into the clinic is a significant milestone for
Aviron's research program," said C. Boyd Clarke, Aviron president and chief
executive officer. "Developing a vaccine to prevent CMV infection is
consistent with Aviron's strategy to discover, develop, and commercialize
innovative vaccines for important diseases."
In 1999, the NIAID commissioned a report by the Institute of Medicine to
help prioritize vaccine research efforts. The report highlighted the public
health need for a CMV vaccine by designating it with the highest priority
rating for vaccine development.
CMV: Leading Cause of Birth Defects
Currently, there is no vaccine available for CMV, an infection with an
estimated annual cost of $4 billion in the United States. CMV is the most
common viral infection known to be transmitted to the fetus during pregnancy
and is the leading infectious cause of birth defects in the United States.
CMV infection is particularly dangerous to fetuses when their mothers are
exposed to the virus for the first time during pregnancy. The NIH estimates
that each year 40,000 infants contract CMV from their mothers and of these,
7,500-10,000 suffer significant birth defects including deafness and mental
retardation.
While 50-85 percent of the U.S. population has been exposed to CMV by age
40, in most individuals with healthy immune systems, no symptoms result from
CMV infection. However, CMV can be life-threatening for immunocompromised
patients, including those with AIDS and those undergoing organ transplants or
chemotherapy.
Aviron is a biopharmaceutical company based in Mountain View, California,
focused on the prevention of disease through innovative vaccine technology.
Actual results may differ materially from the forward-looking statements
contained in this release. Factors that could cause actual results to differ
include, but are not limited to, failure of clinical trials to demonstrate
safety and efficacy, inability to manufacture the vaccine, and the assessment
by regulatory agencies that the company's future license applications for its
CMV vaccine are incomplete or inadequate to approve the product for marketing
to one or more target populations. Additional information concerning factors
that could cause such a difference is contained in Aviron's SEC filings,
including its Annual Report on Form 10-K for the year ended December 31, 1999.
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 found at http://www.aviron.com
SOURCE Aviron
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CONTACT:
media, John Bluth of Aviron, 650-919-3716; or
Claudette Hibbert of Fleishman-Hillard, 212-453-2000, for Aviron;
or investors, John Bluth, 650-919-3716, or Fred Kurland,
650-919-6666, both of Aviron
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