EANS-News: Intercell AG Intercell starts a pivotal Phase II/III efficacy study
with its Pseudomonas aeruginosa vaccine candidate
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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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