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EANS-News: Intercell starts an additional efficacy trial for its patch-based investigational Travelers´ Diarrhea Vaccine System in Asia
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Wien (euro adhoc) - _
» Phase II pilot efficacy trial - placebo controlled field study to evaluate
efficacy and enterotoxigenic E. coli (ETEC) incidence of vaccinated European
travelers to India
» Study designed to complement ongoing Phase III pivotal efficacy trial of
European travelers to Latin America - data expected to further support
licensure for prevention of enterotoxigenic E. coli (ETEC) disease in
travelers to multiple risk regions
» Results expected for end 2010
Vienna (Austria) / Gaithersburg (USA), January 4, 2010 - Intercell AG (VSE:ICLL)
announced today the start of a Phase II study in India as part of its clinical
development program for the investigational Travelers´ Diarrhea (TD) Vaccine
system. This placebo controlled field study with vaccinated travelers from the
EU to India will test the efficacy of the Intercell TD vaccine. The primary
objective of this clinical trial is prevention of all moderate/severe diarrheal
cases in which LT, LT/ST or ST toxins (ETEC) are detected. The trial will enroll
approximately 800 travelers from the UK and Germany.
"The start of our next important TD trial underlines our dynamic route to
licensure and earliest possible commercialization with our marketing partner
GSK. Positive results from this study can greatly support our expected product
target profile" stated Thomas Lingelbach, COO of Intercell AG and CEO of
Intercell USA.
About the Travelers´ Diarrhea Vaccine System
The TD vaccine system is a combination of a patch containing the dry-formulated
LT (heat-labile toxin from E. coli, the vaccine antigen) with a skin preparation
system (SPS). The skin preparation system (SPS) disrupts the stratum corneum of
the skin and prepares the skin for the antigen delivery. The antigen is
dissolved from the patch by transepidermal water loss and diffuses into the
skin. Activated Langerhans cells take the vaccine antigen to the draining lymph
nodes where the immune response is initiated. Currently, this product candidate
is undergoing pivotal Phase III testing in about 1,800 European travelers to
Latin America. First results are expected end 2010 / early 2011.
About Travelers´ Diarrhea
Diarrhea caused by enterotoxigenic E. coli (ETEC) is a disease associated with
significant morbidity in travelers to areas of the world where fecal
contamination of food and water is common. Travelers' diarrhea is generally a
4-5 day illness with frequent loose stools, usually associated with nausea,
vomiting, abdominal cramps, prostration, and dehydration. ETEC is also
implicated in new onsets of post-infectious irritable bowel syndrome (IBS),
which affects 10 to 20% of travelers who develop Travelers' Diarrhea.
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
Digitale Pressemappe: http://www.ots.at/pressemappe/116
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