Positive results for Intercell's Japanese Encephalitis virus vaccine in pivotal clinical trial
Intercell AG announced that a first analysis of the pivotal immunogenicity phase III clinical data of its investigational Japanese encephalitis virus (JEV) vaccine showed positive results and met its primary endpoint. The primary endpoint in this clinical trial comprised both the amount of antibodies in the blood (expressed as geometric mean titer or GMT) and the percentage of subjects reaching protective antibody titers (known as the seroconversion rate).
The clinical trial was designed to compare the immunogenicity of Intercell's investigational vaccine with the mouse brain derived JEVAX® (distributed by Sanofi Pasteur SA, produced by Biken) in a multicenter, multinational, observerblinded, randomized controlled trial. The pivotal immunogenicity phase III clinical trial was conducted at study sites in the United States, Austria, and Germany and included 868 randomized subjects. The pivotal Phase III clinical trial program is designed to meet the regulatory requirements of Intercell´s JEV vaccine in the United States, Europe and Australia. The first market launch is expected to take place in the United States in 2007, if the company obtains timely approvals from the regulatory authorities.
The full phase III clinical trial program consists of several additional clinical trials including a pivotal safety trial, a single shot trial and a covaccination trial for travelers, which are all expected to be completed by early 2007. To date, more than 4,800 of the approximately 5,370 trial participants have been enrolled and vaccinated in these clinical trials. Preparations for the submission of a BLA (Biologics License Application) to the FDA have commenced. In January 2006, an independent data and safety monitoring board concluded that it observed no safety concerns in its first evaluation. In addition, Intercell´s JEV vaccine was granted orphan drug status by the European Commission, resulting in ten years of market exclusivity in the European Union upon product registration.
Intercell´s novel investigational JEV vaccine is a purified, inactivated vaccine for active immunization of adults against the Japanese Encephalitis virus. With over three billion people living in endemic areas, Japanese Encephalitis, a mosquitoborne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia.
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Topic world Antibodies
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