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Enrollment of Phase III study for Intercell’s Japanese Encephalitis Vaccine completed |
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22 Feb 2006 |
Announced that the recruitment for the pivotal immunogenicity Phase III trial of its Japanese Encephalitis vaccine has successfully been completed earlier than initially planned.
VIENNA, Austria | Feb 21, 2006 | Intercell AG (VSE, “ICLL”) announced today that the recruitment for the pivotal immunogenicity Phase III trial of its Japanese Encephalitis vaccine has successfully been completed earlier than initially planned.
The pivotal Phase III trial, which is conducted at study sites in Austria, Germany and in the United States, has now reached its randomization goal of 868 subjects. The study is designed to demonstrate non-inferiority in terms of immunogenicity of the Intercell vaccine compared to JE-VAX®, in a multicenter, multinational, observer blinded, randomized parallel group design. The comparable vaccine product, JE-VAX®, is still produced on mouse brain and currently the only Japanese Encephalitis vaccine approved in the US.
In addition to the immunogenicity trial, Intercell’s Phase III study program consists of several other trials, including a pivotal safety trial, a single shot trial and a co-vaccination trial for travelers. In total, more than 4000 out of approximately 5000 subjects have been randomized into the Phase III trials.
"The earlier than planned completion of recruitment for this pivotal Phase III study, which is crucial for registration, and the fast progress made within the entire Phase III program, underline the planned development strategy for our lead product candidate which is fully on track towards an expected market introduction in 2007", states Gerd Zettlmeissl, CEO of Intercell AG.
First results of these trials are expected in mid 2006. Biologics License Applications (BLA) will be made in the United States, European Union and Australia.
About Intercell’s JE vaccine
Intercell´s novel Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization of adults against the Japanese Encephalitis virus. With over 3 billion people living in endemic areas, Japanese Encephalitis, a mosquito-borne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia.
In a Phase II head-to-head comparison with JE-VAX®, Intercell’s 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
SOURCE: Intercell, AG |
