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

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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.



Further inquiry note:
Intercell AG
Lucia Malfent
Head of 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

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