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Intercell AG

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Enrollment of Phase III study for Intercell’s Japanese Encephalitis Vaccine completed

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
21.02.2006
Intercell AG (VSE, "ICLL") announced today that the recruitment for
the pivotal immunogenicity Phase III trial of its Japanese
Encephalitis vaccine has successfully been completed earlier than
initially planned.
The pivotal Phase III trial, which is conducted at study sites in
Austria, Germany and in the United States, has now reached its
randomization goal of 868 subjects. The study is designed to
demonstrate non-inferiority in terms of immunogenicity of the
Intercell vaccine compared to JE-VAX®, in a multicenter,
multinational, observer blinded, randomized parallel group design.
The comparable vaccine product, JE-VAX®, is still produced on mouse
brain and currently the only Japanese Encephalitis vaccine approved
in the US.
In addition to the immunogenicity trial, Intercell’s Phase III study
program consists of several other trials, including a pivotal safety
trial, a single shot trial and a co-vaccination trial for travelers.
In total, more than 4000 out of approximately 5000 subjects have been
randomized into the Phase III trials.
"The earlier than planned completion of recruitment for this pivotal
Phase III study, which is crucial for registration, and the fast
progress made within the entire Phase III program, underline the
planned development strategy for our lead product candidate which is
fully on track towards an expected market introduction in 2007",
states Gerd Zettlmeissl, CEO of Intercell AG.
First results of these trials are expected in mid 2006. Biologics
License Applications (BLA) will be made in the United States,
European Union 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. 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.
In a Phase II head-to-head comparison with JE-VAX®, Intercell’s
vaccine was shown to be:
» Less reactogenic - both in frequency and intensity » 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
This communication expressly or implicitly contains certain
forward-looking statements concerning Intercell AG and its business.
Such statements involve certain known and unknown risks,
uncertainties and other factors which could cause the actual results,
financial condition, performance or achievements of Intercell AG to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Intercell AG is providing this communication as of this date and does
not undertake to update any forward-looking statements contained
herein as a result of new information, future events or otherwise.
end of announcement                               euro adhoc 21.02.2006 17:44:58

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: A0D8HW
Börsen: Wiener Börse AG / official market

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Plus de actualités: Intercell AG