Intercell AG (VSE, "ICLL") announced today that the safety
analyses for the pivotal Phase III safety trial of its investigational Japanese Encephalitis vaccine are positive.
The pivotal Phase III safety trial was conducted at 39 study sites in Austria, Germany, Romania,
Israel, Australia, New Zealand and in the US, and included 2,683 randomized subjects. The study was designed to analyze the safety and tolerability of Intercell's investigational vaccine in a
multicenter, multinational, double-blind, placebo-controlled randomized study.
Major endpoints of this study were the frequency of adverse events in both test groups, as well as local tolerability findings in both groups. First analyses of this trial show that Intercell's
investigational Japanese Encephalitis vaccine was systemically and locally well tolerated. Overall, the local tolerability and general safety profile of the Intercell JE vaccine appeared to be
comparable with placebo.
The Phase III clinical trial program consists of several additional clinical trials including a pivotal
immunogenicity 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. The pivotal Phase III clinical trial program is designed to meet regulatory requirements in the United States, Europe and Australia. Assuming approval by the regulatory authorities, the first market launch is anticipated for 2007. Preparations for the submission of a BLA (Biologics License Application) to the FDA have commenced.
Full clinical results of the pivotal immunogenicity trial are planned to be presented at the Annual
Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), November 12-16,
Atlanta, and full clinical results of the pivotal safety trial are planned to be presented at the 10th
Conference of the International Society of Travel Medicine, May 20-24, 2007 in Vancouver, Canada.
About Intercell's investigational JE vaccine
Intercell´s novel investigational 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 former Phase II head-to-head comparison with the U.S. licensed product JE-VAX®, 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 JE vaccine, manufactured in the Company's propriety manufacturing facility in
Scotland, is novel as it is using tissue culture rather than live organisms and does not contain any stabilizers or preservatives in its formulation.
About Intercell AG
Intercell AG is a biotechnology company focused on the research, development, manufacturing
and future commercialization of innovative vaccines for prevention and treatment of infectious
diseases for which there exists substantial unaddressed medical need. The Company develops
antigens and immunizers (adjuvants) which are derived from its proprietary technology platforms
and has in-house GMP manufacturing capability. Intercell has strategic partnerships with a
number of global pharmaceutical companies, including Novartis AG, sanofi pasteur S.A.,
Merck&Co., Inc., the Statens Serum Institut and Kirin Brewery Co., Ltd. The Company has a broad development pipeline with a vaccine product candidate for Japanese Encephalitis in Phase III, a vaccine product candidate for Hepatitis C in Phase II, partnered vaccine candidates for Tuberculosis and S. aureus , which are in Phase I, and more than five other product candidates focused on infectious diseases in pre-clinical development. Intercell is listed on the Vienna stock exchange under the symbol "ICLL".
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