EANS-News: Intercell AG / Intercell announces first data from its Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections

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Research & Development

Wien (euro adhoc) - Intercell announces first data from its Phase I
clinical trial with vaccine candidate to prevent Clostridium
difficile infections

» Intercell is progressing its vaccine candidate against Clostridium
difficile, the major cause of nosocomial diarrhea, into the target
population of elderly subjects based on initial data from its Phase I
study » Data show good safety and immunogenicity of the vaccine
candidate and indicate functionality of the induced antibodies »
Second part of the study in the target population of elderly subjects
will be initiated

Vienna (Austria), October 24, 2011 - Intercell AG (VSE: ICLL) today
announced first data from a Phase I clinical trial with the company's
vaccine candidate IC84 to prevent disease caused by the bacterium
Clostridium difficile (C. difficile). 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 C. difficile. The
toxins are known to be disease-causing and anti-toxin immunity can be
protective.

This Phase I trial is a first-in-man study to obtain safety and
immunogenicity data. The first part of the study is in a population
of healthy adults up to 65 years. The second part is in healthy
elderly subjects above 65 years of age as this age group is
considered to represent the main target population for a C. difficile
vaccine.

The first part of the study has enrolled 60 healthy adults (18-65
years). Three different alum-adjuvanted vaccine candidate
concentrations were tested in a 3 times-vaccination schedule; two of
the three vaccine concentrations were additionally tested without
adjuvant.

An independent Data Safety Monitoring Board (DSMB) reviewed safety as
primary objective of the study and did not identify any safety
concern in any of the IC84 treatment arms.

IC84 induced antibodies reacted with both native toxins A and B of C.
difficile. A dose response to the vaccine candidate could be
observed; the non-adjuvanted candidates were at least as immunogenic
as the adjuvanted for both toxins, respectively.

Functionality of IC84-induced antibodies could be shown in
toxin-neutralizing assays.

Based on the data form the first part of the study, the two higher
doses will be carried forward to the second part of the study for
dose-confirmation in elderly. Also, the necessity of the adjuvant
will need to be confirmed in the elderly, who might respond
differently to vaccination than the younger subjects due to
immunosenescence. Modification of the vaccination schedule will be
implemented to potentially further optimize the immune response in
elderly.

Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com

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: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime
stockmarkets: official market: Wien
language: English