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