euro adhoc: Intercell AG
other
Intercell starts pivotal Phase III clinical
trials of Japanese Encephalitis Vaccine
Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.
19.09.2005
Vienna, Austria, September 19, 2005 - Intercell AG (VSE, "ICLL") announced today the start of global multi-center Phase III clinical trials of its Japanese Encephalitis vaccine, IC51. Japanese Encephalitis (JE) is a mosquito-borne flaviviral infection and the leading cause of viral encephalitis in Asia. The infection is a major health problem throughout Asia where 3 billion people live in JE-endemic areas. A safe and efficacious traveler vaccine for tourists visiting Asian countries will meet a high unaddressed medical need.
The global phase III program consists of a series of immunogenicity and safety trials, and will enroll more than 4,900 subjects. Furthermore, a one time vaccination schedule is included in the Phase III program.
The immunogenicity studies will take place in Austria, Germany and the United States. The study is designed to demonstrate non-inferiority of the Intercell vaccine compared to JE-VAX®. JE-VAX® is the only Japanese Encephalitis vaccine approved in the US. The trial will compare the ability of IC51 and JE-VAX® to elicit seroconversion. The first individuals in this pivotal immunogenicity trial have received their first vaccinations today. So far, about 300 subjects have already been enrolled for the Phase III program.
An additional series of Phase III trials will gather further immunogenicity and safety data in approximately 4,000 subjects. These subjects will be recruited in Austria, Australia, Bulgaria, Germany, Israel, the Netherlands, New Zealand, Romania, UK and the United States.
The clinical trial material for the Phase III Studies is produced according to GMP standards in Intercells own manufacturing plant in Livingston, Scotland. "The start of the pivotal clinical trials, which is fully supported by the respective regulatory authorities, demonstrates again Intercells very strong commitment and capability to develop innovative vaccines ", states Gerd Zettlmeissl, Chief Operating Officer of Intercell AG. "Our lead product is fully on track towards registration and market introduction."
First results of these trials are expected in mid 2006. License applications will then be made for 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 a Phase II head-to-head comparison with JE-VAX®, Intercells vaccine was shown to be:
» 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
» Less reactogenic - both in frequency and intensity
Intercells focus is to make this product available to travellers and military personnel from the EU and the US to endemic areas. Furthermore it has recently concluded strategic alliances with Biological E and CSL Ltd. to market the product in Asia and Australia, respectively, where the disease is endemic.
end of announcement euro adhoc 19.09.2005 07:35:48
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:
Börsen: Wiener Börse AG / official market