euro adhoc: Intercell AG
other
Intercells Japanese Encephalitis vaccine
safe in Phase III trials
Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
12.01.2006
Intercell AG (VSE, "ICLL") announced today the achievement of an important milestone in the progress of its international, multi-center Phase III clinical trial program of its Japanese Encephalitis vaccine:
An independent Data and Safety Monitoring Board (DSMB), consisting of two European and one US expert from the field of Clinical Pharmacology and Vaccinology, has reviewed and evaluated the safety data from the first proportion of subjects vaccinated in the Phase III trial. After discussion of all safety data provided to the board members, the DSMB unanimously concluded that no safety concerns have been observed. From these preliminary results, the safety assessment is favorable which supports the ongoing rapid recruitment of approximately 5,000 subjects in the entire Phase III program. Completion of recruitment for the pivotal safety and the pivotal immunogenicity trial is expected early this year.
Results of these Phase III trials are expected in mid 2006. First license applications will be made in the US, EU and Australia.
About Intercells JE vaccine
Intercell´s novel Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization of adults against the Japanese Encephalitis virus and has successfully concluded Phase II clinical trials.
In the Phase II head-to-head comparison with JE-VAX®, Intercells vaccine was shown to be: » Less reactogenic - both in frequency and intensity » More potent - higher antibody levels at all doses studied one month after the immunizations; this vaccine also showed high seroconversion rates one month after a single dose » More convenient - 2 doses versus 3 doses and liquid versus freeze-dried format » More persistent - higher persistence of antibodies two years after primary immunization
This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
end of announcement euro adhoc 12.01.2006 17:36:07
Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market