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Intercell AG

EANS-Adhoc: Intercell AG
Intercell AG Announces First Subject Enrolled in a Phase II Trial for the further development of its investigational Vaccine Enhancement Patch to improve Pandemic Influenza prevention in Collaboration with U.S. Department ...

  ad-hoc disclosure transmitted by euro adhoc with the aim of a Europe-wide
  distribution. The issuer is solely responsible for the content of this
  announcement.
Research & Development
28.05.2009
» Phase II clinical trial investigating the effectiveness of 
Intercell´s   Vaccine Enhancement (VE) Patch in combination with an 
injectable H5N1   pandemic influenza vaccine started today in the 
U.S. » The study is fully funded by HHS - this is the second study 
conducted under   a 5 year USD 128 m contract with the HHS » 
Intercell´s VE Patch may reduce the dosage and improve protection 
against   an H5N1 pandemic influenza outbreak with only a single dose
vaccine   application
Vienna (Austria) and Gaithersburg (USA) May 28, 2009 - Intercell AG 
(VSE: ICLL) today announced that it has advanced its efforts to 
develop its VE Patch to improve prevention of H5N1 pandemic influenza
with the start of a Phase II clinical trial. The randomized and 
blinded study aims to determine the optimal dosage of both 
Intercell´s VE Patch and the H5N1 influenza vaccine injected 
concomitantly, when combined with each other in a single dose 
regimen. The trial will be conducted in the U.S. and is expected to 
enroll 500 subjects at six study sites.
"The commencement of this Phase II study represents an important 
milestone in the clinical development of our VE Patch technology and 
in the partnership with HHS for use of our technology in providing 
potentially improved Pandemic Influenza vaccines" stated Thomas 
Lingelbach, COO of Intercell AG and CEO of Intercell USA. "The recent
H1N1 influenza situation certainly highlights again the important 
global public health need in this arena. If we achieve our goal to 
achieve full protection with only a single dose plus patch this means
an enormous logistical advantage making PanFlu immunization 
feasible".
The H5N1 pandemic influenza vaccine tested in the study comprises 
Intercell´s VE Patch and an injectable H5N1 influenza vaccine 
manufactured by Solvay Biologicals, B.V. (Netherlands).
In 2008 Intercell announced the results of a first clinical trial 
where the VE Patch was combined with an injectable H5N1 influenza 
vaccine, also manufactured by Solvay Biologicals B.V. The data 
revealed that a single 45-microgram dose of the H5N1 influenza 
vaccine, when administered with the Intercell VE Patch containing 
50-microgram LT adjuvant, was sufficient to provide an immune 
response seen to be protective in 73% of the vaccinees. This was a 
statistically significant improvement when compared to the subjects 
receiving the H5N1 influenza vaccine alone. Thus this was the first 
time that a single dose of H5N1 pandemic influenza vaccine met the 
level of protection suggested in U.S. Food and Drug Administration 
guidance that a pandemic vaccine needs to achieve immune response 
levels in at least 70% of the vaccine recipients in order to be 
considered protective.
About Pandemic Influenza
Three major influenza pandemics have occurred in the 20th century 
leading to the death of more than 50 million people globally. By U.S.
government estimates, pandemic influenza has a greater potential to 
cause deaths and illnesses than virtually any other natural health 
threat.
About Intercell´s Vaccine Enhancement Patch
Intercell believes that its VE Patch when applied in conjunction with
an injectable vaccine has the potential for the development of 
improved vaccine products. Preclinical studies with different 
vaccines and the Phase I/II clinical study results using the VE Patch
with an injectable H5N1 Influenza vaccine suggest that this strategy 
may be used for other injectable vaccines which are already approved 
or in development where improved immunogenicity, decreased antigen 
doses, or fewer immunization visits are desired.
end of announcement                               euro adhoc

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market

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