EANS-Adhoc: Intercell reports Phase II Study Results of its Vaccine Enhancement Patch for Pandemic Influenza

Intercell intends to proceed with clinical studies

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02.07.2010

Vienna (Austria)/Gaithersburg (USA), July 2, 2010 - Intercell AG (VSE: ICLL)
today announced the results of a Phase II clinical trial of its investigational
Vaccine Enhancement Patch (VEP) system for avian H5N1 influenza. In this
development program, Intercell is working under a contract with the U.S.
Department of Health and Human Services (HHS) to develop a dose-sparing approach
with potential for a single dose immunization against pandemic influenza that
combines a H5N1 vaccine with Intercell´s LT adjuvant patch.

Following encouraging pre-clinical and clinical Phase I proof-of-concept trials
conducted under this HHS contract, the clinical Phase II study was designed to
determine the safety and the optimal combination/dose of an injectable H5N1
influenza vaccine (30 and 45µg antigen) and Intercell´s VEP (50 and 100µg LT
adjuvant) applied at the injection site. A total of 500 healthy adults were
recruited in 6 study groups.

The study did not identify the optimal combination of antigen and adjuvant
because no statistically significant difference in seroprotection rates as
measured by Haemagglutinin Inhibition (HI) assay was observed when comparing
groups with and without VEP.

However, the study results demonstrated a good safety profile for all doses of
injectable vaccine and adjuvant patches studied. Furthermore, a dose-dependent
response to the H5N1 antigen was observed. Anti-LT IgG titers in study subjects
receiving the patch confirmed that Intercell´s VEP could consistently deliver
the vaccine adjuvant.

Intercell intends to conduct further clinical evaluation using its VEP in
combination with an injectable H5N1 vaccine to be supplied by GlaxoSmithKline
(GSK) as part of a collaborative agreement signed in December 2009.
HHS and Intercell are currently considering the next steps for this development
program.

"Single-dose protection against highly pathogenic pandemic influenza strains
such as H5N1 is an important goal for pandemic protection, but one which has
been shown to be challenging ", said Thomas Lingelbach, Chief Operating Officer
of Intercell and CEO & President Intercell USA Inc. "We think that despite the
inconclusive results, our Vaccine Enhancement Patch is uniquely positioned to
have the potential to achieve single-dose protection and hence Intercell using
its partner GSK´s vaccine intend to proceed with further clinical evaluation."

Further inquiry note:
Intercell AG
Lucia Malfent
Vice President, Global Head Corporate Communications
Tel. +43 1 20620-1303
[email protected]
end of announcement euro adhoc
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issuer:   Intercell AG
          Campus Vienna Biocenter  3
          A-1030 Wien 
phone:    +43 1 20620-0
FAX:      +43 1 20620-800
mail:     [email protected] 
WWW:      www.intercell.com
sector:   Biotechnology

ISIN: AT0000612601
indexes: ATX Prime, ATX
stockmarkets: official market: Wien
language: English

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