Positive Results For Intercell AG's Japanese Encephalitis Virus Vaccine In Pivotal Clinical Trial; Phase III Meets Primary Endpoint
The clinical trial was designed to compare the immunogenicity of Intercell's investigational vaccine with the mouse brain derived JE VAX® (distributed by Sanofi Pasteur SA, produced by Biken) in a multicenter, multinational, observer-blinded, 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 co-vaccination 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.
"Based on the positive immunogenicity and safety profile observed so far, we believe that our innovative product will replace the mouse-brain derived products currently available on the market and that we will be able to expand the market for this traveler vaccine significantly. We are very proud that we are one of the few companies in the rapidly growing vaccine market that is running a globally successful phase III clinical program, states Intercell's Chief Executive Officer, Gerd Zettlmeissl.
Full clinical trial data will be presented at the Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), which is scheduled to take place from November 12 to 16, 2006, in Atlanta.
About Intercell's investigational JEV vaccine
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 mosquito-borne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia.
In a former phase II head-to-head comparison with JE-VAX®, the only JEV vaccine licensed in the United States, Intercell's investigational 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
-- More convenient - 2 doses versus 3 doses and liquid versus freeze-dried format
-- More persistent - higher persistence of antibodies two years after primary immunization
Intercell's JEV vaccine, manufactured in the Company's propriety manufacturing facility in Scotland, is novel as it is based on tissue culture rather than live organisms and does not contain any stabilizers or preservatives in its formulation.
http://www.intercell.com