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Intercell starts pivotal Phase III clinical trials of Japanese Encephalitis Vaccine

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
19.09.2005
Vienna, Austria, September 19, 2005 - Intercell AG (VSE, "ICLL")
announced today the start of global multi-center Phase III clinical
trials of its Japanese Encephalitis vaccine, IC51. Japanese
Encephalitis (JE) is a mosquito-borne flaviviral infection and the
leading cause of viral encephalitis in Asia. The infection is a major
health problem throughout Asia where 3 billion people live in
JE-endemic areas. A safe and efficacious traveler vaccine for
tourists visiting Asian countries will meet a high unaddressed
medical need.
The global phase III program consists of a series of immunogenicity
and safety trials, and will enroll more than 4,900 subjects.
Furthermore, a one time vaccination schedule is included in the Phase
III program.
The immunogenicity studies will take place in Austria, Germany and
the United States. The study is designed to demonstrate
non-inferiority of the Intercell vaccine compared to JE-VAX®. JE-VAX®
is the only Japanese Encephalitis vaccine approved in the US. The
trial will compare the ability of IC51 and JE-VAX® to elicit
seroconversion. The first individuals in this pivotal immunogenicity
trial have received their first vaccinations today. So far, about 300
subjects have already been enrolled for the Phase III program.
An additional series of Phase III trials will gather further
immunogenicity and safety data in approximately 4,000 subjects. These
subjects will be recruited in Austria, Australia, Bulgaria, Germany,
Israel, the Netherlands, New Zealand, Romania, UK and the United
States.
The clinical trial material for the Phase III Studies is produced
according to GMP standards in Intercell’s own manufacturing plant in
Livingston, Scotland. "The start of the pivotal clinical trials,
which is fully supported by the respective regulatory authorities,
demonstrates again Intercell’s very strong commitment and capability
to develop innovative vaccines ", states Gerd Zettlmeissl, Chief
Operating Officer of Intercell AG.  "Our lead product is fully on
track towards registration and market introduction."
First results of these trials are expected in mid 2006. License
applications will then be made for the US, EU and Australia.
About Intercell’s JE vaccine Intercell´s novel Japanese Encephalitis
vaccine is a purified, inactivated vaccine for active immunization of
adults against the Japanese Encephalitis virus and has successfully
concluded Phase II clinical trials.  In a Phase II head-to-head
comparison with JE-VAX®, Intercell’s vaccine was shown to be:
» More potent - higher antibody levels at all doses studied one month
after    the immunizations; this vaccine also showed high
seroconversion rates one    month after a single dose
» More convenient - 2 doses versus 3 doses and liquid versus
freeze-dried   format
» More persistent - higher persistence of antibodies two years after
primary    immunization
» Less reactogenic - both in frequency and intensity
Intercell’s focus is to make this product available to travellers and
military personnel from the EU and the US to endemic areas.
Furthermore it has recently concluded strategic alliances with
Biological E and CSL Ltd. to market the product in Asia and
Australia, respectively, where the disease is endemic.
end of announcement                               euro adhoc 19.09.2005 07:35:48

Further inquiry note:

Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN:
Börsen: Wiener Börse AG / official market

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