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Intercell starts an additional efficacy trial for its patch-based investigational Travelers' Diarrhea Vaccine System in Asia
- Phase II pilot efficacy trial - placebo controlled field study to evaluate efficacy and enterotoxigenic E. coli (ETEC) incidence of vaccinated European travelers to India
- Study designed to complement ongoing Phase III pivotal efficacy trial of European travelers to Latin America - data expected to further support licensure for prevention of enterotoxigenic E. coli (ETEC) disease in travelers to multiple risk regions
- Results expected for end 2010
Vienna (Austria) / Gaithersburg (USA), January 4, 2010 - Intercell AG (VSE:ICLL) announced today the start of a Phase II study in India as part of its clinical development program for the investigational Travelers' Diarrhea (TD) Vaccine system. This placebo controlled field study with vaccinated travelers from the EU to India will test the efficacy of the Intercell TD vaccine. The primary objective of this clinical trial is prevention of all moderate/severe diarrheal cases in which LT, LT/ST or ST toxins (ETEC) are detected. The trial will enroll approximately 800 travelers from the UK and Germany.
"The start of our next important TD trial underlines our dynamic route to licensure and earliest possible commercialization with our marketing partner GSK. Positive results from this study can greatly support our expected product target profile" stated Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA.
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