EANS-Adhoc: Intercell starts European Pivotal Phase III clinical trial for the patch-based Travelers' Diarrhea Vaccine

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14.10.2009

» Placebo controlled field study to confirm vaccine efficacy in
travelers to Guatemala and Mexico

Vienna (Austria) and Gaithersburg (USA), October 14, 2009 - Intercell AG (VSE:
ICLL) announced today that its Travelers' Diarrhea (TD) Vaccine Patch has
entered clinical Phase III development. A pivotal efficacy field study started
with the first subjects vaccinated in the United Kingdom. The randomized and
placebo-controlled study with travelers from Europe to Mexico and Guatemala will
evaluate the efficacy of the TD Vaccine Patch to actively immunize against
moderate to severe ETEC (enterotoxigenic E. coli) disease in a field setting.
The trial will be conducted in the European Union, mainly the UK and Germany,
and will include 1,800 subjects travelling to Mexico and Guatemala.

"The start of our pivotal efficacy Phase III trial is a key achievement in the
clinical development of the worldwide first vaccine delivered with a patch,"
stated Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA. "ETEC is
the main cause for diarrhea in travelers. Therefore, a patch-based TD vaccine
has the potential to significantly reduce the disease burden, severity and
incidence of travelers´ diarrhea episodes."

The TD vaccine system consists of a self-adhesive patch containing the vaccine
antigen, the LT - heat-labile toxin - from E. coli, and a single-use device used
to prepare the skin at the site of patch administration, the Skin Preparation
System (SPS). Intercell combines the classical toxin approach to vaccination
with its innovative patch-based, needle-free delivery system. The SPS partially
disrupts the stratum corneum of the skin. The dry patch contains the antigen in
a stabilizing excipient formulation and delivers the antigen to the skin.
Activated Langerhans cells take up the antigen and deliver it to the draining
lymph nodes.

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.

In an earlier randomized, double blind placebo-controlled Phase II field trial
the vaccine showed excellent immunogenicity and reduced the risk of clinically
significant diarrheal episodes in travelers to Mexico and Guatemala. The started
Phase III trial with 1,800 subjects will evaluate the efficacy of the TD Vaccine
for prevention of moderate to severe ETEC disease in the same field setting.

About Travelers' Diarrhea

Travelers' Diarrhea (TD) is caused by consumption of contaminated food or water.
The onset of TD normally occurs within the first week of travel, but may occur
at any time, or even after returning home. An infection results in watery stools
three or more times in a 24-hour period, sometimes in combination with fever,
nausea, bloating, and abdominal cramps. Also, between 10 and 30% of those who
develop TD will suffer from Irritable Bowel Syndrome (IBS), a chronic disorder
of the intestine.

Annually, approximately 20 million out of nearly 55 million international
travelers develop Travelers' Diarrhea while visiting endemic areas in Asia,
Africa, and South America. Furthermore, Diarrhea caused by ETEC sickens 210
million children in endemic areas each year, killing more than 350.000 annually.
Young adults and individuals with suppressed immune systems are at an especially
high risk of infection.

Currently, there is no licensed vaccine targeting primarily TD and the most
effective treatment of Diarrhea is oral rehydration therapy (ORT), the simple
replacement of fluids and salts.

Further inquiry note:
Intercell AG
Corporate Communications
Tel. +43 1 20620-1222 / 1116
[email protected]
Ende der Mitteilung 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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