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10.12.2008 - euroadhoc / Börse / stock market / research
Intercell Reports Study Showing Japanese Encephalitis Vaccine is Safe and Immunogenic in Children at ASTMH Meeting in New Orleans

Utl.: » Presentation at ASTMH Meeting Underscores Safety and Immunogenicity 
        of Vaccine in a Phase II trial in children
      » Additional Presentation Demonstrates Excellent Safety during 
        6-Month of Follow-Up across Phase III trials in adults
      » Marketing approval for the adult vaccine in the U.S., Europe 
        and Australia expected for 2008 =
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  ots.CorporateNews transmitted by euro adhoc. The issuer is responsible for
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Vienna/Austria, Cambridge and New Orleans/USA, December 10, 2008 - Intercell AG
(VSE: ICLL) today presented results of a clinical study of its Japanese
Encephalitis vaccine IC51 in children at the American Society for Tropical
Medicine and Hygiene Annual Meeting in New Orleans. The clinical study in
children from 1 to 3 years of age demonstrated excellent immunogenicity with a
safety profile similar to placebo.
 
The company also presented follow-up data demonstrating the safety of IC51 in
vaccines aged 18 years and older, followed for at least 6 months and for 24
months in a long-term follow-up study. In addition, Novartis Vaccines, which
will market and distribute the vaccine in the U.S., Europe and other parts of
the world, hosted a symposium at the meeting that gave an overview of the risk
of the virus in tourists, expatriates and military personnel.
"These results convincingly demonstrate the strengths of our vaccine, and the
encouraging safety data underscores the fact that IC51 is a major and welcome
step forward in the prevention of one of Asia's deadliest infections," said
Thomas Lingelbach, Chief Operating Officer of Intercell "We look forward to
working with our partners, Novartis and CSL, to commercialize this product in
the U.S., Europe and Australia next year."
Japanese Encephalitis, a deadly mosquito-borne infection that kills as many as
30 percent who show symptoms, is a significant and serious public health threat
in Asia, where the disease is endemic. As many as 50,000 are diagnosed with the
disease every year.
"We are pleased with the progress of Intercell's international licensing
processes for a vaccine for such a significant unmet medical need. We have
aligned our efforts to prepare for successful product launches for the traveler
markets starting in early 2009", said Dr. Andrin Oswald, Chief Executive Officer
of Novartis Vaccines and Diagnostics.
Study results - IC51 in children
The open-label pediatric study compared 48 children who were given IC51 at
either the standard dose or a half dose with 12 children given a comparator
Japanese Encephalitis vaccine called JenceVac®. More than 95 percent of children
who received Intercell´s vaccine regardless of dose, generated a protective
antibody response, compared with 90.9 percent of those who received the
comparator vaccine. IC51 showed a good safety profile when given in the full and
half adult dose. All observed adverse events were mild in nature.
Study results - IC51 in adults
The 6 months safety data analysis pooled more than 4,700 volunteers, including
3,558 volunteers who received IC51. Local reactions affected 54.1% in the IC51
group vs. 61.1% in the JE-VAX® group, a statistically significant difference.
About Japanese Encephalitis
Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to
50,000 a year, causing 10-15,000 deaths up to 50% of survivors have persistent
neurological sequelae. Japanese Encephalitis is the leading cause of viral
neurological disease and disability in Asia, and is the most important viral
encephalitis in Asia. The disease is most common in several developing countries
in Asia. No treatment is currently available; only vaccination effectively
prevents the disease. Though other vaccines have been available in the past, use
of those products has been limited by reports of neurological reactions.
About Intercell's JE vaccine IC51
Intercell's novel JE vaccine is a purified, inactivated vaccine for active
immunization against the Japanese Encephalitis virus. With over 3 billion people
living in endemic areas, Japanese Encephalitis, a mosquito-borne flaviviral
infection, is the leading cause of childhood encephalitis and viral encephalitis
in Asia. The vaccine was developed for over 10 years under a Collaborative
Research and Development Agreement (CRADA) with the Walter Reed Army Institute
of Research (WRAIR).
Intercell's Phase III trials for the vaccine found that the vaccine demonstrated
excellent immunogenicity against Japanese Encephalitis and an overall clinical
safety profile similar to placebo combined with an excellent local tolerability
profile. That data was published in The Lancet in December 2007:
» The immunogenicity was comparable to that of the U.S. licensed product, 
  JE-VAX® 
» Intercell's vaccine demonstrated an overall clinical safety profile similar
  to placebo 
» Further, Intercell's JE vaccine had an excellent local tolerability profile
  in the head-to-head study with JE-VAX®

Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
emitter:      Intercell AG
              Campus Vienna Biocenter  3
              A-1030 Wien 
phone:        +43 1 20620-0
FAX:          +43 1 20620-800
mail:         investors@intercell.com 
WWW:          www.intercell.com
sector:       Biotechnology
ISIN:         AT0000612601
indexes:      ATX Prime, ATX
stockmarkets: official market: Wiener Börse AG 
language:     English