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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Research & Development

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."

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

Vice President, Global Head Corporate Communications

Tel. +43 1 20620-1303

lmalfent@intercell.com

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