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Intercell AG Announces Q3 2010 Results and Updates on R&D Progress and Management
Date:11/9/2010

esponse and was well tolerated. Vaccine-related serious side-effects which would raise any safety concern were not observed. The results provide a strong basis for evaluation of further development options. Intercell and its partner Novartis will determine next steps.

Clostridium difficile program planned to enter clinic: After successful pre-clinical trials, Intercell is progressing its vaccine candidate to prevent infections with Clostridium difficile (C. diff). C. diff is the leading cause for nosocomial Diarrhea in Europe and the U.S. A Phase I clinical study is expected to start in 2010.

Staphylococcus aureus vaccine (V710) on track: The Phase II/III study conducted and funded by Merck & Co., Inc. in cardiothoracic surgery patients for the investigational S. aureus vaccine is progressing to plan. The first critical interim analysis (surpassing futility) is expected in 2011.

Good progress in development pipeline – programs progressing according to plan

  • Recruitment for the pivotal Phase III study of approximately 2,000 travelers for Intercell's investigational Travelers' Diarrhea (TD) Vaccine Patch is completed. The first data from that trial, conducted in travelers to Mexico and Guatemala, is expected for end 2010/early 2011. The enrollment of a complementary 800-traveler Phase II study in those travelling to India has also been completed; first data is expected in Q4 2010. The trial in India is the first study outside South America and has the potential to demonstrate proof of concept for the vaccine in Asia.
  • Intercell will pursue activities with GSK to prepare markets as soon as data on Phase II and Phase III trials becomes available. Diarrhea is the most common health problem among travelers from developed countries who visit developing areas and most of the diarrheal cases in travelers are caused by bacteria, primarily by ETEC strains (Escherichia coli).
  • Intercell and GSK will continue de
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  • SOURCE Intercell AG
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