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

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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
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

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