EANS-News: Intercell AG /Intercell announces positive results from two clinical
Phase III studies supporting pediatric label extension of JE vaccine for
children traveling to endemic areas
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Research & Development
Wien (euro adhoc) - -
» Japanese Encephalitis (JE) vaccine showed to be highly immunogenic in children
aged 2 months to <18 years with a safety profile comparable to other licensed
pediatric vaccines
» Compilation of Phase III clinical data package supporting pediatric licensure
applications for IXIARO®/JESPECT® completed - regulatory submissions to major
agencies expected for Q2 2012
Vienna (Austria), February 01, 2012 - Intercell AG (VSE; 'ICLL') today announced
the successful completion of a pivotal Phase III trial in 1869 children
conducted in the Philippines and favorable interim data from a second Phase III
trial in EU, US and Australia. Analysis of both studies showed that the vaccine
was well tolerated and immunogenic in children aged 2 months to <18 years. Based
on these data, Intercell will submit applications for the approval of an
IXIARO®/JESPECT® pediatric label extension to major regulatory agencies in Q2
2012.
The pivotal study in the Philippines was designed as a safety, immunogenicity
and dose confirmation trial. The multi-center, randomized and active-controlled
study enrolled 1,869 children aged 2 months to <18 years. 1,411 children
received IXIARO®/JESPECT® at doses of either 0.25 ml / 3µg (half of an adult
dose, ages below 3 years) or 0.5ml / 6µg (full adult dose, ages 12 years and
older). For ages 3 to <12 years the full adult dose was found appropriate in a
dose-confirmation component of the trial. In the control group, 64 children
received Prevnar® and 394 children received Havrix®. In this pivotal study, the
safety profile with overall adverse event rate up to Day 56 of 84.0% (<1 year)
and 62.0% (>= 1 year) was comparable to the control vaccines Prevnar® (87.5%, <1
year) and Havrix® (59.6%, >=1 year).
The second study is an ongoing multi-center, open label, single arm trial in
which 100 children from US, EU and Australia who are travelling to JEV-endemic
areas are planned to receive IXIARO®/JESPECT®. The overall adverse event rate up
to Day 56 in the interim analysis was 66.7%.
In both studies, more than 99% of children who received the appropriate dose of
IXIARO®/JESPECT® achieved neutralizing antibody titers above the WHO-recognized
protective titer.
"We are very pleased about the positive pivotal data in support of our label
extension to protect also traveling children against Japanese Encephalitis - a
key element of the further growth for Intercell´s first commercial product",
states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Following the approval and launch of Intercell's vaccine against Japanese
Encephalitis for adult travelers and military personnel in Europe, the United
States, Canada, Hong Kong (IXIARO®) and Australia (JESPECT®), the development of
a vaccine to protect children traveling to endemic areas from Japanese
Encephalitis has been a major goal of the Company.
The vaccine is manufactured by Intercell AG´s wholly-owned subsidiary Intercell
Biomedical Ltd. at our cGMP facility in Livingston, Scotland. The pediatric
approval is expected by the end of 2012 or beginning of 2013.
Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com
end of announcement euro adhoc
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company: 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
stockmarkets: official market: Wien
language: English