MOUNTAIN VIEW, Calif., Sept. 25 /PRNewswire/ -- Aviron (Nasdaq: AVIR)
announced today an update on the status of six new and ongoing clinical trials
of its intranasal respiratory vaccine program.  The intranasal influenza
vaccine recently proved 93 percent effective in a Phase III clinical trial in
children compared to placebo. New trials seek to further explore the vaccine's
safety and effectiveness in adults, and to evaluate benefits for high risk
populations, such as children with asthma and the elderly.
    Patient recruitment will begin immediately in a Phase II trial of Aviron's
intranasal parainfluenza virus type 3 (PIV-3) vaccine. Yesterday, Aviron
shipped the vaccine to clinical sites participating in the study. PIV-3 is a
leading cause of croup, bronchitis, bronchiolitis and pneumonia in young
children.
    "We have initiated three trials in the past month and will begin
vaccinating patients in two additional trials by the end of September. These
trials, involving 30 clinical sites and more than 6,000 participants in all
age groups, are intended to help support the precise claims to be submitted to
the FDA when we file our PLA in mid-1998," said Paul M. Mendelman, M.D., Vice
President of Clinical Research at Aviron.

    Phase III Intranasal Influenza in Children - Year 2
    Results from year one showed only one percent of 1,070 children who
received the vaccine developed culture-confirmed influenza during last year's
flu season, versus 18 percent of 532 children who received placebo.
    This flu season, children involved in the first-year trial will be
re-vaccinated with a single dose of the intranasal vaccine or placebo.
Investigators will follow them again this year to test the safety and efficacy
of vaccination in subsequent flu seasons. Individual study participants will
not learn whether they are in the vaccine or placebo group until after this
second year study is completed.
    The vaccine is formulated according to FDA and CDC recommendations to
protect against flu strains expected to be circulating during this flu season:
Two strains from last year's vaccine (A/Wuhan/359/95-like H3N2 and
B/Beijing/184/93-like) and one new one (A/Bayern/07/95-like H1N1).
Vaccinations began September 2.
    Children have the highest attack rate from influenza, as high as 30 to 40
percent each year, and they are important in the spread of the disease to the
family and community. Other than those with certain high risk conditions,
children are not routinely vaccinated against influenza.

    Phase III Trial in Adults Looks at Cost Effectiveness
    A Phase III randomized, double-blinded, placebo-controlled trial in
healthy working  adults began September 18. The trial, enrolling
3,600-4,500 participants, will assess the safety and effectiveness of the
intranasal influenza vaccine in reducing work loss and medical costs due to
influenza. Aviron previously reported that its intranasal influenza vaccine
provided 85 percent protection against laboratory confirmed influenza in an
experimental challenge study with 92 healthy adults.
    "After AIDS, influenza is the most expensive infectious disease in the
United States," said Jo White, M.D., Senior Vice President of Medical Affairs
at Aviron. "This study is intended to evaluate the economic advantages of
comprehensive vaccination with our vaccine."

    Phase III Trial in High Risk Elderly, Combining Spray and Shot
    In an average influenza season, 20,000 Americans die of influenza or its
complications. Most of these are people over age 65 with additional risk
factors, such as emphysema, chronic bronchitis, or congestive heart failure.
    This phase III trial will evaluate the safety of administering Aviron's
intranasal live vaccine at the same time subjects are injected with the
inactivated flu shot. Enrollment of 200 participants began on September 4 and
will be completed in November.
    "It has been shown that such a co-administration with a previous
formulation of the intranasal live vaccine reduced influenza cases
by 61 percent compared to the flu shot alone. An efficacy trial for
co-administration using Aviron's formulation is planned for the 1998 flu
season," said Mendelman.

    Phase III Trial in Children with Asthma
    Aviron is also planning trials to test the safety of its intranasal live
vaccine in children with moderate to severe asthma. Children with asthma are
at particularly high risk of developing more serious conditions such as
pneumonia and death.
    The randomized, double-blind, placebo-controlled trial will enroll
60 children from late September through October. Historical data supports the
safety of the vaccine in children with asthma, but data from the Aviron trial
will be used in the Company's FDA application.

    Patient Trial to Ascertain Manufacturing Consistency
    Aviron has completed enrollment of a 500-patient randomized, placebo-
controlled consistency lot trial to provide evidence for the FDA that the
intranasal influenza vaccine can be manufactured repeatedly at a consistent
quality level. Participants received their first dose in April and their
second  in September. The data will be analyzed in 1Q 98. Nine monovalent lots
of vaccine were formulated into three trivalent lots to be compared with the
vaccine used in the successful efficacy trial and placebo.
    "We will need to demonstrate to the FDA that, in addition to being safe
and effective, we can manufacture the vaccine consistently,"  Mendelman said.
"These data will provide the information needed to support licensure of the
vaccine."

    Phase II Trial Looks at Infants & Parainfluenza
    Aviron will initiate a Phase II trial to evaluate the safety,
tolerability, immunogenicity, and infectivity of parainfluenza virus type
3 (PIV-3) vaccine in infants. Approximately 150 two-month-old infants will be
randomized to receive three primary doses and a booster dose of PIV-3 vaccine
or placebo, administered concurrently with pediatric vaccines recommended at
the corresponding ages.
    Primary infection with PIV-3 is an important cause of acute lower
respiratory tract disease in children, including croup, bronchitis,
bronchiolitis, and pneumonia.
    "Developing a vaccine that is both safe and immunogenic for young children
may not only prevent infections, but could significantly reduce the severity
of illness," said Kathleen Coelingh, Ph.D., Project Leader of the PIV program
at Aviron.
    For these studies, Statistics Collaborative (Washington, D.C.) and The
Emmes Corporation (Potomac, MD) provide statistical support, and IBRD-ROSTRUM
GLOBAL, (Irvine, CA), PAREXEL (San Diego, CA) and PPD Pharmaco (Denver, CO)
serve as the Contract Research Organizations monitoring the clinical sites.
    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).  Aviron is also developing -- in collaboration with SmithKline Beecham
Biologicals -- a subunit vaccine against Epstein Barr Virus (EBV) infection, a
major cause of infectious mononucleosis.
    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, 1996.

Link to this page: