MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ -- Aviron (Nasdaq: AVIR) today
announced the initiation of a Phase 2 clinical trial of an investigational
vaccine against Epstein-Barr virus (EBV) being developed under its license
with SmithKline Beecham Biologicals (SBB). The initiation of this trial
triggers a $1.5 million milestone payment to Aviron.
No vaccine is currently available for EBV, the principal cause of
infectious mononucleosis (mono). Mono affects an estimated 250,000 young
adults in the United States and Europe annually. Studies of the
U.S. population indicate that approximately 90 percent of adults have been
infected with EBV.
The randomized, double-blind trial evaluating safety and immunogenicity
has enrolled 79 of 81 individuals aged 18-45. The study is being conducted at
two universities in Belgium.
The vaccine under development combines EBV vaccine technology developed by
Aviron scientists with proprietary adjuvant technology developed by SBB.
Adjuvants are substances included in vaccines to further stimulate the immune
system.
"Moving into broader clinical trials with a vaccine for EBV reinforces
Aviron's commitment to commercialize a robust pipeline of vaccines that
address unmet medical needs. Infectious mononucleosis is a widespread disease
with a particularly devastating impact in high schools and colleges, often
interrupting a student's studies or extracurricular activities for extended
periods of time," said Harry Greenberg, M.D., Aviron senior vice president and
chief scientific officer.
According to the National Institutes of Health, between 25 and 70 percent
of young adults will develop mono when exposed to EBV for the first time. EBV
also is associated with certain cancers of the head and neck, and can cause
complications in immunocompromised individuals, including people with HIV and
AIDS.
In 1999, Aviron announced that a randomized, double-blind Phase 1 study in
67 young adults indicated that the vaccine appeared to be safe and well
tolerated in seronegative individuals. Seronegative individuals have had no
prior exposure to EBV. Although the study was not designed to evaluate
efficacy, laboratory tests indicated evidence of immune response in vaccine
recipients.
In 1995, Aviron and SBB entered into an agreement for the development and
commercialization of an EBV vaccine which outlines a series of milestone and
product royalty payments from SBB to Aviron relating to the achievement of
clinical development and regulatory milestones. Under the agreement, Aviron
has the option to co-distribute the vaccine in U.S. markets. A subsequent
agreement between Aviron and ARCH Development Corporation (ARCH) entitles ARCH
to receive 25 percent of the payments Aviron receives from SBB.
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 assessment by
regulatory agencies that the company's future license applications for its
vaccines 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, 650-919-3716, or Asha
Jennings, 650-919-1429, or investors, John Bluth, 650-919-3716,
or Fred Kurland, 650-919-6666, all of Aviron; or media, Claudette
Hibbert of Fleishman-Hillard, 212-453-2000, for Aviron
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