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Intercell AG

EANS-News: Intercell starts an additional efficacy trial for its patch-based investigational Travelers´ Diarrhea Vaccine System in Asia

Wien (euro adhoc) -

  Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Research & Development
_ » 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.
end of announcement                               euro adhoc

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

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