EANS-News: Intercell AG Intercell and Statens Serum Institut (SSI) progress
vaccine clinical development to fight Tuberculosis
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Research & Development
Wien (euro adhoc) - » The combination of SSI´s novel tuberculosis subunit
vaccine candidate and Intercell´s proprietary IC31® adjuvant enters Phase II
clinical trial in HIV-positive individuals
» First results expected in 2013, a second Phase II study is planned for 2012
Vienna (Austria) / Copenhagen (Denmark), January 11, 2012 - Intercell AG (VSE;
"ICLL") and Statens Serum Institut (SSI) today announced the start of the first
Phase II study within their collaboration to develop vaccines against
Tuberculosis (TB). The randomised, double-blind, clinical trial evaluating the
immunogenicity and safety of two doses of an adjuvanted TB subunit vaccine
candidate, H1IC (a combination of SSI´s Ag85B-ESAT-6 + Intercell´s IC31®), in
HIV-positive individuals, will be conducted in South Africa and Tanzania. The
study is funded by EDCTP (European and Developing Countries Clinical Trials
Partnership) and conducted in collaboration with Aurum Institute, Ifakara Health
Institute, Swiss Tropical and Public Health Institute, London School of Hygiene
and Tropical Medicine and the South African TB Vaccine Initiative.
First results are expected in 2013. A second Phase II clinical study is being
planned to assess the safety and immunogenicity of the vaccine candidate in
healthy adolescents.
Previous Phase I clinical trials in Europe and Africa have demonstrated that SSI
and Intercell´s collaborative novel investigational TB vaccine is safe and very
immunogenic in different populations. The new H1IC vaccine candidate from SSI is
a recombinant subunit vaccine based on two important TB antigens resulting from
SSI´s research pipeline combined with Intercell´s proprietary adjuvant IC31® and
ultimately targeted against adults and adolescents.
"We are very proud that the clinical evaluation of the H1IC vaccine is
progressing so well and that this vaccine is playing a key role in the
development of a much-needed novel efficient TB vaccine", say´s Peter Lawætz
Andersen, Vice President Vaccine R&D, SSI.
"The start of this Phase II clinical trial is not only a further validation of
Intercell´s proprietary IC31® adjuvant technology, it is foremost an notable
step towards addressing an important medical need with a novel vaccine against
TB", says Thomas Lingelbach, CEO of Intercell AG.
The collaboration between SSI and Intercell in the field of Tuberculosis
currently includes three clinical vaccine candidates, all formulated with
Intercell´s IC31® adjuvant: H1IC, now entering Phase II, H4IC, currently in
Phase I (partnered with Sanofi and AERAS, "AERAS 404"), and H56IC, currently in
a Bill and Melinda Gates Foundation-funded Phase I in partnership with AERAS and
the South African Tuberculosis Vaccine Initiative.
Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com
end of announcement euro adhoc
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company: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime
stockmarkets: official market: Wien
language: English