EANS-News: Intercell starts a Phase I clinical trial for a new vaccine to prevent Clostridium difficile infections

-
» After successful pre-clinical trials, Intercell is progressing
its vaccine
candidate against Clostridium difficile, the major
cause of nosocomial
diarrhea, into the clinical development stage
» Initiation of a first-in-man Phase I clinical trial in healthy
subjects
» Study aims to obtain safety and immunogenicity data -
initial results
expected in Q3 2011

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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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Research & Development

Subtitle: - » After successful pre-clinical trials, Intercell is
progressing its vaccine candidate against Clostridium difficile,
the major cause of nosocomial diarrhea, into the clinical
development stage » Initiation of a first-in-man Phase I clinical
trial in healthy subjects » Study aims to obtain safety and
immunogenicity data - initial results expected in Q3 2011

Vienna (Austria), December 22, 2010 - (euro adhoc) - Intercell AG
(VSE: ICLL) today announced that a Phase I clinical trial with the
company's vaccine candidate IC84 to prevent disease caused by the
bacterium Clostridium difficile (C. difficile) has started. The
pathogen is one of the main causes of nosocomial diarrhea.

Intercell's vaccine candidate is a recombinant protein vaccine
consisting of two truncated toxins A and B from Clostridium
difficile. The toxins are known to be disease-causing and anti-toxin
immunity can be protective. The vaccine candidate will be tested with
or without the adjuvant aluminum hydroxide.

This Phase I trial is a first-in-man study to obtain safety and
immunogenicity data in a small population of healthy adults aged
18-65 years in the first part of the study as well as from healthy
elderly subjects above 65 years of age in a second part of the study,
the latter age group representing the main target population for a
Clostridium difficile vaccine. 60 healthy adults and up to 100
elderly subjects will be enrolled in this open-label study. Three
different alum-adjuvanted vaccine concentrations will be tested; two
of the three vaccine concentrations will also be tested without
adjuvant.

"The initiation of this clinical Phase I trial is an important step
to further strengthen Intercell's leading position in the development
of vaccines against hospital-acquired infections", commented
Intercell's COO, Thomas Lingelbach.

There is no vaccine available against Clostridium difficile, which
represents the leading cause of nosocomial diarrhea in the U.S. and
EU and is an increasing burden to the health care system. The disease
affects in particular elderly patients with prolonged antibiotic
treatment and patients with underlying co-morbidities or
immunocompromising conditions. Antibiotic treatment is the current
standard of care of Clostridium difficile-associated disease but has
its limitations due to increasing treatment failures attributable to
antibiotic resistance and disease relapse in up to 30% of patients
after discontinuation of the treatment.

Potential indications for a Clostridium difficile vaccine include
community prophylaxis for the elderly, prophylaxis in hospitalized
patients with particular risk factors for Clostridium
difficile-associated disease and the prevention of relapsing disease.

end of announcement 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