Intercell Reports Study Showing Japanese Encephalitis Vaccine is Safe and Immunogenic in Children at ASTMH Meeting in New Orleans
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» Presentation at ASTMH Meeting Underscores Safety and Immunogenicity of Vaccine in a Phase II trial in children » Additional Presentation Demonstrates Excellent Safety during 6-Month of Follow-Up across Phase III trials in adults » Marketing approval for the adult vaccine in the U.S., Europe and Australia expected for 2008
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Vienna/Austria, Cambridge and New Orleans/USA, December 10, 2008 - Intercell AG (VSE: ICLL) today presented results of a clinical study of its Japanese Encephalitis vaccine IC51 in children at the American Society for Tropical Medicine and Hygiene Annual Meeting in New Orleans. The clinical study in children from 1 to 3 years of age demonstrated excellent immunogenicity with a safety profile similar to placebo.
The company also presented follow-up data demonstrating the safety of IC51 in vaccines aged 18 years and older, followed for at least 6 months and for 24 months in a long-term follow-up study. In addition, Novartis Vaccines, which will market and distribute the vaccine in the U.S., Europe and other parts of the world, hosted a symposium at the meeting that gave an overview of the risk of the virus in tourists, expatriates and military personnel.
"These results convincingly demonstrate the strengths of our vaccine, and the encouraging safety data underscores the fact that IC51 is a major and welcome step forward in the prevention of one of Asia's deadliest infections," said Thomas Lingelbach, Chief Operating Officer of Intercell "We look forward to working with our partners, Novartis and CSL, to commercialize this product in the U.S., Europe and Australia next year."
Japanese Encephalitis, a deadly mosquito-borne infection that kills as many as 30 percent who show symptoms, is a significant and serious public health threat in Asia, where the disease is endemic. As many as 50,000 are diagnosed with the disease every year.
"We are pleased with the progress of Intercell's international licensing processes for a vaccine for such a significant unmet medical need. We have aligned our efforts to prepare for successful product launches for the traveler markets starting in early 2009", said Dr. Andrin Oswald, Chief Executive Officer of Novartis Vaccines and Diagnostics.
Study results - IC51 in children
The open-label pediatric study compared 48 children who were given IC51 at either the standard dose or a half dose with 12 children given a comparator Japanese Encephalitis vaccine called JenceVac®. More than 95 percent of children who received Intercell´s vaccine regardless of dose, generated a protective antibody response, compared with 90.9 percent of those who received the comparator vaccine. IC51 showed a good safety profile when given in the full and half adult dose. All observed adverse events were mild in nature.
Study results - IC51 in adults
The 6 months safety data analysis pooled more than 4,700 volunteers, including 3,558 volunteers who received IC51. Local reactions affected 54.1% in the IC51 group vs. 61.1% in the JE-VAX® group, a statistically significant difference.
About Japanese Encephalitis
Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to 50,000 a year, causing 10-15,000 deaths up to 50% of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia, and is the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia. No treatment is currently available; only vaccination effectively prevents the disease. Though other vaccines have been available in the past, use of those products has been limited by reports of neurological reactions.
About Intercell's JE vaccine IC51
Intercell's novel JE vaccine is a purified, inactivated vaccine for active immunization 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. The vaccine was developed for over 10 years under a Collaborative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR).
Intercell's Phase III trials for the vaccine found that the vaccine demonstrated excellent immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to placebo combined with an excellent local tolerability profile. That data was published in The Lancet in December 2007:
» The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX® » Intercell's vaccine demonstrated an overall clinical safety profile similar to placebo » Further, Intercell's JE vaccine had an excellent local tolerability profile in the head-to-head study with JE-VAX®
end of announcement euro adhoc
Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
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