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

-
» 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

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Research & Development

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.

end of announcement euro adhoc
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Intercell AG

Lucia Malfent

Head of Corporate Communications

Tel. +43 1 20620-1303

lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market