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

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Research & Development

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.

Ende der Mitteilung euro adhoc
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Intercell AG

Corporate Communications

Tel. +43 1 20620-1222 / 1116

communications@intercell.com

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