EANS-News: Intercell provides update on Phase III trial for Travelers' Diarrhea Vaccine Patch
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Vienna (Austria) and Gaithersburg (USA), April 29, 2009 (euro adhoc) - Intercell AG (VSE: ICLL) today informed regulators, partners and other parties involved in its planned pivotal Phase III efficacy study for the investigational Travelers' Diarrhea Vaccine that the company will wait to initiate this clinical trial until the swine flu outbreak in Mexico has resolved.
"It is the company´s highest priority to assure the safety of the individual subjects who would travel to Mexico or Guatemala to participate in the study. As those travelers today could be at a high risk of contracting swine flu, it is clear that as a consequence, Intercell will not initiate initiate this Phase III trial at the present time.", explained Gerd Zettlmeissl, CEO of Intercell.
In the planned Phase III pivotal efficacy study, known as the "Trek Study", 1,800 subjects from Europe and the United States are to be enrolled, vaccinated, and followed during travel to Mexico or Guatemala for the development of diarrhea.
Intercell will closely monitor the situation and work with local, national and international health authorities to identify the appropriate timing for the start of this study. The Company will continue with the preparatory processes for the study, which will commence pending resolution of the swine flu situation and is confident that the current development plans and timelines for the product should remain unchanged.
About Travelers' Diarrhea
Travelers' Diarrhea is most commonly caused by enterotoxigenic Escherichia coli (ETEC). An estimated 10 million travelers succumb to diarrhea illness annually with the highest risk in developing countries of Latin America, Africa, Asia and the Middle East. The illness usually results in increased frequency, volume and weight of stool. Typically, a traveler experiences four to five loose or watery bowel movements each day, with symptoms of nausea, vomiting, abdominal cramping, bloating, and general feeling of discomfort lasting, on average, 3-5 days. During this time, subjects are considered incapacitated or bedridden, and/or are unable to participate in planned activities.
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Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wiener Börse AG / official market