EANS-News: Intercell AG Intercell receives positive scientific advice from EMA
for Pseudomonas vaccine Phase II/III-study
--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------
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