EANS-Adhoc: Intercell provides update on ongoing Phase II vaccine studies

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Research & Development

16.12.2009

» Pseudomonas vaccine: Study in intensive care patients to
investigate immunogenicity and safety of a Pseudomonas aeruginosa
vaccine and to assess Pseudomonas infection rates - Interim results
from the study confirms good safety and immunogenicity of the
vaccine » Pandemic Influenza: Intercell originally anticipated it
would have data available at the end of the year, but due to data
processing not yet completed, data will only be available at the
beginning of next year

Vienna (Austria), December 16, 2009 - Intercell AG (VSE; "ICLL")
today announced that interim data from a Phase II clinical trial
investigating the company's vaccine candidate for the prevention of
infections with the bacterium Pseudomonas aeruginosa are available.
Intercell's vaccine is a recombinant subunit vaccine consisting of
two outer membrane proteins of Pseudomonas aeruginosa.

In the Phase II clinical trial, mechanically ventilated intensive
care patients are vaccinated with Intercell's prophylactic
Pseudomonas aeruginosa vaccine. These patients are at a particularly
high risk of acquiring severe and often life-threatening forms of
Pseudomonas aeruginosa infections, such as ventilator-associated
Pneumonia, Sepsis or soft tissue infection. Two different dosages of
alum-adjuvanted vaccine and one formulation without adjuvant are used
in the placebo-controlled trial.

The interim analysis from 225 out of 400 total patients to be
vaccinated in this study has shown good safety and tolerability of
the vaccine. In addition, robust immunogenicity by antibody induction
which were assessed by standard and avidity IgG ELISA and functional
opsonization assays could be shown. Functional antibodies are
expected to be the major protective mechanism against Pseudomonas
aeruginosa infections. Immune responses and safety data observed in
intensive care patients appear largely comparable to results from a
preceding Phase I trial in healthy volunteers. Based on these interim
data an independent Safety Board recommended the continuation of the
study. Meanwhile, the trial is fully enrolled, having achieved
recruitment of 400 patients in more than 40 intensive care units in
nine countries in Europe and Latin America.

"We are pleased with the state of the clinical conduct although the
interim data are not yet decisive. Intercell's approach to develop
vaccines against the major causes of nosocomial infections has the
clear potential to become the unique strategic solution for a
dramatically increasing medical need," comments Thomas Lingelbach,
COO of Intercell AG.

Study details

As another objective, the current Phase II trial investigates the
feasibility of performing pivotal efficacy studies in this target
population. The interim analysis confirms the anticipated number of
Pseudomonas aeruginosa infections; in total 73/225 patients tested
positive for Pseudomonas aeruginosa at any point in time, 23/225
fulfilled the secondary endpoint definitions of invasive disease
(Bacteremia, Pneumonia). This observed rate of ~10% is well within
expectations, as only study sites with estimated infection rates of
10-25% were selected for this trial. These results confirm the
development strategy for Intercell's Pseudomonas aeruginosa vaccine
and suggest feasibility of the pivotal assessment of vaccine efficacy
in future Phase III trials.

However, no conclusions concerning pilot efficacy can yet be drawn at
this stage with regards to a meaningful reduction of infections in
the different study groups. This assessment will only be concluded at
the point of the final data analysis of all 400 patients in the
study.

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