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Intercell AG

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

Vienna (Austria), December 22, 2010 - (euro adhoc) -

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

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

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