EANS-Adhoc: Intercell reports positive results from its Phase II Pseudomonas aeruginosa investigational vaccine study for certain hospital acquired infections

--------------------------------------------------------------------------------
ad-hoc disclosure transmitted by euro adhoc with the aim of a Europe-wide
distribution. The issuer is solely responsible for the content of this
announcement.
--------------------------------------------------------------------------------

Research & Development

25.10.2010

» Primary Immunogenicity and Safety Endpoints met » Significant
reduction of mortality observed versus alum as placebo control in
a 400 patient trial » Feasibility to assess Pseudomonas aeruginosa
vaccine efficacy in ventilated intensive care patients successfully
demonstrated » Intercell is carefully considering the appropriate
next steps to take with the vaccine candidate

Vienna (Austria), October 25, 2010 - Intercell AG (VSE; "INTERCELL")
today announced results from a Phase II clinical trial involving the
company's investigational nosocomial vaccine candidate (IC43) against
infections with the bacterium Pseudomonas aeruginosa, a leading cause
of hospital-acquired infections with increasing antibiotic resistance
and hence a very high unmet medical need.

In the randomized, controlled Phase II clinical trial (33 sites in 8
countries), about 400 mechanically ventilated intensive care
patients, who are at particular high risk of acquiring severe and
often life-threatening forms of Pseudomonas aeruginosa infections,
such as Ventilator-Associated Pneumonia (VAP), sepsis or soft tissue
infection were vaccinated on days zero and seven in four treatment
groups receiving 100 or 200mcg alum-adjuvanted vaccine, 100mcg
non-adjuvanted vaccine or alum as placebo control.

The primary endpoint of the study was met in that all vaccine groups
showed good seroconversion rates (65 - 81%) with IgG antibody
Geometric Mean Titers (GMTs) (995-2117 ELISA units/ml). There were no
significant differences in treatment emergent adverse events between
the treatment arms and local and systemic tolerability appeared to be
good, as far as assessable in this study population. The number and
nature of reported drug related adverse events does not raise any
safety concern and has been confirmed earlier by a Data Safety
Monitoring Board (DSMB) based on interim data.

Secondary immunogenicity endpoints were also met in this study and
included IgG response assessed seven times over a period of 90 days,
measurement of functional antibody activity by opsonophagocytosis
assay, and measurement of antibody avidity.

Overall robust immunogenicity following second vaccination was
observed in all vaccine groups. A dose-response could be observed,
whereas alum did not show a clear immune-enhancing effect. Antibody
avidity was similar in all vaccine groups. Functional
opsonozation-uptake could be shown and correlated well with
vaccine-induced IgG titers. Induction of functional antibodies is
expected to be the major protective mechanism against Pseudomonas
aeruginosa infections. Immune responses in intensive care patients
appeared weaker compared to results from a preceding Phase I trial in
healthy volunteers. This was not unexpected due to the reduced
general health condition of patients enrolled.

Although this trial was not powered for efficacy the Clinical
Endpoint Committee (CEC) confirmed infection rates and mortality were
recorded within the secondary endpoints analysis.

A lower mortality rate was observed in all vaccine groups as compared
to the control group. The reduction in mortality rate was
statistically significant (p = 0,0196) for the non-adjuvanted vaccine
(21.7% day 28 mortality in the not-adjuvanted IC43 group compared to
40.0% day 28 mortality in the placebo group). No significant
difference in Pseudomonas aeruginosa infection rates between any of
the groups was apparent. However, this is likely to be due to the
relatively small sample size of the current Phase II study. Larger,
sufficiently powered clinical studies would be required to validate
and verify any vaccine effects on mortality and infection rates.

As another key objective, the current Phase II trial investigated the
feasibility of performing pivotal efficacy studies in this difficult
target population: Final data confirm the anticipated number of
Pseudomonas aeruginosa infections. The observed attack rate of 6 -
14% is well within expectations as only study sites with estimated
Pseudomonas aeruginosa invasive infection rates of 10 - 25% were
selected for this trial. These results confirm the development
strategy for Intercells´s Pseudomonas aeruginosa vaccine and could
allow a pivotal assessment of the vaccine efficacy in potential
future pivotal Phase III trials.

"With this successfully conducted clinical trial Intercell further
strengthens its leading position in the field of hospital acquired
infections. As Pseudomonas is known as a major contributor to death
in the complex patient population studied in the present trial we are
pleased to see reduced mortality in the vaccination groups. We are
looking forward to further evaluating the underlying mechanisms and
the future potential development options for this vaccine candidate"
comments Thomas Lingelbach, Chief Operating Officer of Intercell AG.

Novartis Vaccines and Diagnostics have certain option rights with
respect to this vaccine candidate and will review the data to
determine next steps together with Intercell.

end of announcement euro adhoc
--------------------------------------------------------------------------------

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