EANS-News: Intercell AG / Intercell receives positive scientific advice from EMA for Pseudomonas vaccine Phase II/III-study

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Research & Development

Wien (euro adhoc) - (Austria), October 12, 2011 - Today Intercell AG
(VSE: ICLL) announced that it has received positive Scientific Advice
from the European Medicines Agency (EMA) regarding the planned Phase
II/III efficacy trial of its investigational Pseudomonas aeruginosa
vaccine. The company obtained confirmation for the proposed key
elements of the study design, i.e. size, population, and primary
endpoint.

The trial follows a Phase II study in which a lower mortality rate
was observed in the vaccine groups as compared to the control group.
Based on the positive feedback Intercell intends to initiate the
confirmatory efficacy study in Q1/2012. First interim data are
expected mid 2013. The program is part of the Strategic Alliance
between Novartis and Intercell - the trial will be executed by
Intercell and cost will be shared between both parties.

The planned double blind study is powered to show a clinically
meaningful reduction in overall mortality with statistical
significance between the vaccine and control group and target
enrollement is about 800 patients. The trial is expected to be
conducted in various countries in the EU, involving up to 50 study
sites. Two study groups, both receiving standard of care in addition
to vaccine or placebo, will be compared. Subjects in the vaccine
group which will comprise about 400 ventilated ICU patients will be
vaccinated twice within a 7-day interval with the non-adjuvanted
product formulation that was found to most impact observed survival
in the previous Phase II clinical study. Primary endpoint of the
trial will be mortality at day 28 after first vaccination in both
study groups. Secondary objectives are to investigate Pseudomonas
aeruginosa infections, infection-related mortality as well as immune
responses to the vaccine candidate and its safety and tolerability.

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