EANS-News: Intercell AG / Intercell starts a pivotal Phase II/III efficacy study with its Pseudomonas aeruginosa vaccine candidate

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Research & Development

Wien (euro adhoc) - Vienna (Austria), March 13, 2012 - Today
Intercell AG (VSE: ICLL) announced the start of a pivotal Phase
II/III efficacy trial of its investigational Pseudomonas aeruginosa
vaccine. The trial follows an exploratory Phase II study in which
lower all-cause mortality rates were observed in the vaccine groups
as compared to the control group.

Pseudomonas aeruginosa is one of the leading causes of nosocomial
infections, which are infections acquired or occurring during the
course of hospitalization for other conditions. Of the 2 million
nosocomial infections in the U.S. alone per year, 10% are caused by
Pseudomonas aeruginosa. The bacterium is the number 1 cause of
ventilator-associated pneumonia, the number 2 cause of
hospital-acquired pneumonia and the number 4 cause of surgical site
infections. Currently, there is no vaccine against Pseudomonas
aeruginosa available.

The Phase II/III trial is a randomized, placebo-controlled
double-blind study which will enroll a total of 800 ventilated
intensive-care unit patients in approximately 40 study sites across
five European countries. Patients will be vaccinated twice with
either the Pseudomonas aeruginosa vaccine candidate or placebo at a
7-day interval in addition to the standard of care. The Pseudomonas
aeruginosa vaccine candidate used will be the non-adjuvanted product
formulation which was found to most impact the observed survival in
the previous Phase II clinical study. The primary objective of the
trial is to compare all-cause mortality rates at day 28 after first
vaccination between the two study groups. Secondary objectives
include comparison of infection-related mortality-rates and
Pseudomonas aeruginosa infection rates between the groups and to
investigate the vaccine candidate´s immunogenicity, safety and
tolerability.

The study is sufficiently powered to show a clinically meaningful
reduction in all-cause mortality with statistical significance
between the vaccine and control group. A futility analysis is planned
after approximately 400 patients have been enrolled. The study has
previously received positive scientific advice from the European
Medicines Agency (EMA).

"We are very pleased that we can investigate our vaccine candidate to
confirm the encouraging findings obtained in the previous Phase II
trial. There are not many vaccine candidates in the final steps of
development and this one could result in a major medical
breakthrough", said Thomas Lingelbach, CEO of Intercell AG.

First interim data are expected mid-2013. The Pseudomonas aeruginosa
program is part of the Strategic Alliance between Novartis and
Intercell - the trial will be conducted by Intercell and costs will
be shared between both parties.

Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com

end of announcement euro adhoc
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company: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime
stockmarkets: official market: Wien
language: English