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

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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.

Further inquiry note:
Intercell AG
Corporate Communications
Tel. +43 1 20620-1222/-1116
[email protected]
end of announcement euro adhoc
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company: 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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