EANS-News: Intercell announces initiation in the U.S. of a Phase III study for vaccine to protect children against Japanese Encephalitis

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Subtitle: -
» First Phase III trial towards pediatric label extension for IXIARO®/JESPECT®
preventing Japanese Encephalitis (JE) in travelers to endemic countries
» Important development step towards making IXIARO/JESPECT available to
children

Vienna (Austria), December 28, 2009 (euro adhoc) - Intercell AG today announced
the initiation of a pediatric Phase III study for IXIARO/JESPECT in children
above 6 months of age travelling from U.S., Europe and Australia to JE-endemic
areas. The vaccine is currently licensed as adult vaccine in Europe, Canada, the
United States (IXIARO) and Australia (JESPECT).

In the U.S., the vaccine is licensed for those above 17 years of age, and in
Europe, Canada and Australia it is licensed for those above 18 years of age.
This multi-national study including 100 children will be the first of two Phase
III trials in support of the IXIARO/JESPECT label extension for pediatric
licensure for children above 2 months of age. The study will investigate safety
and immunogenicity of the vaccine.

"We are very pleased about the progress in our pediatric development program for
this vaccine. The start of the current Phase III study is a major step towards
making our modern cell culture-derived product available also to travelling
children and to the children of those serving in the military who are bringing
their families to countries with JE-endemic areas", states Thomas Lingelbach,
Chief Operating Officer of Intercell AG.

The development program up to licensure for pediatric use of IXIARO/JESPECT has
been agreed with the regulatory authorities. A Phase II study conducted in 2007
comprising children aged 1 to 3 years of age by Intercells partner Biological E.
suggested that the vaccine has a comparable immunogenicity and safety profile in
young children to that in adults, even if only half of the adult dose is
administered.

A second Phase III study will be conducted as a pivotal trial in an endemic
region, namely, the Philippines and Malaysia. This multi-center, randomized and
controlled study will include 1,859 children of whom 1,401 will receive
IXIARO/JESPECT. The study will evaluate the safety profile of the vaccine
compared to HAVRIX®720 and Prevnar®. In addition, immunogenicity will be studied
in a subgroup of children, and the vaccine dose for ages three to below 12 years
will be confirmed.

Following the approval and launch of Intercell's vaccine against Japanese
Encephalitis for adult travelers and military personnel in Europe, Canada, the
USA and Australia, the further development of the vaccine to protect children
travelling to endemic areas from Japanese Encephalitis has been a major goal of
the company. Intercell is also working with its partner Biological E. of
Hyderabad, India, to make a JE vaccine available in endemic regions.

Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
[email protected]
end of announcement euro adhoc
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issuer: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: [email protected]
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime, ATX
stockmarkets: official market: Wien
language: English

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