• 08.06.2011, 13:01:05
  • /
  • OTE0004

EANS-News: Intercell AG / Merck and Intercell AG Announce Termination of Phase II/III Clinical Trial of Investigational Staphylococcus aureus Vaccine, V710

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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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Wien (euro adhoc) - WHITEHOUSE STATION, N.J. and VIENNA, June 8, 2011 - Merck
(NYSE:MRK), known as MSD outside the United States and Canada, and Intercell AG
(VSE: ICLL) today announced that following a detailed analysis of the data from
the Phase II/III clinical trial evaluating V710, an investigational vaccine for
the prevention of Staphylococcus aureus (S. aureus) infection, the independent
Data Monitoring Committee (DMC) has unanimously recommended termination of the
study.

As previously announced, following a pre-planned meeting in April, the DMC
informed Merck that the trial had not met the formal futility criteria.
However, the DMC recommended that enrollment in the Phase II/III clinical trial
be suspended pending completion by Merck of additional analyses on the benefits
and risks of vaccination. Following further review of the statistical analyses
by the DMC - which also considered events that had occurred after the
pre-specified data cutoff date utilized for the April meeting - the
recommendation to terminate was made based upon both the observation that V710
was unlikely to demonstrate a statistically significant clinical benefit as well
as a safety concern regarding overall mortality and multi-organ dysfunction that
occurred with greater frequency in vaccine recipients, compared with placebo
recipients. In the additional analyses that were performed, this safety
difference was not found to be statistically significant and was also determined
not to warrant any action beyond routine safety follow-up. Merck plans to
present the final detailed findings of the clinical trial at an upcoming medical
meeting.

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, ATX
stockmarkets: official market: Wien
language: English

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | CNE

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