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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Research & Development
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.
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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: EnglishContact:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market