euro adhoc: Intercell AG / other / Novel tuberculosis vaccine shows promising immunogenicity and safety profile

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Research & Development

14.03.2007

» The Danish Statens Serum Institut (SSI) and Intercell report
promising data from a phase I clinical trial with a tuberculosis
(TB) subunit vaccine

» The vaccine is produced by SSI and contains Intercell’s adjuvant
IC31™

» The project which is supported by the European Union aims to either
replace the available TB vaccine "BCG"/"Calmette vaccine" or to
boost its activity in adults.

Copenhagen (Denmark)/Vienna (Austria), March 14, 2007 - Statens Serum
Institut (SSI) and Intercell announced today that their collaborative
novel tuberculosis (TB) vaccine is safe and very immunogenic in
healthy individuals in a phase I clinical trial. The preliminary data
will be presented on the Keystone Symposia on Tuberculosis in
Vancouver, March 24, 2007 by Prof. Peter Andersen from the SSI and
April 12, 2007 at the 3rd Vienna Vaccines Conference by
co-investigator Prof. Tom Ottenhoff, Leiden University Medical
Center, Netherlands. Based on these results the partners will
initiate a clinical trial with latent TB-infected and BCG-vaccinated
individuals later in 2007.

The new H1 vaccine 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™. The phase I
clinical trial was performed at the Department of Infectious Diseases
(headed by Prof. Jaap van Dissel) at Leiden University Medical Center
in the Netherlands and was supported by the European Union-funded
program "TB-VAC".

"The successful outcome of the phase I trial has paved the way to
move our novel TB vaccine forward. It is designed to function in a
stand alone schedule, as well as in combination with previous
exposure(s) to BCG or other closely related mycobacteria. It seems
that our decision to combine our antigen with IC31™ has been a sound
judgement on the base of our preclinical data", explains Peter
Andersen, Director of Vaccine Research and Development, SSI.

Intercell’s CSO, Alexander von Gabain, commented: "Our adjuvant IC31™
proved an outstanding profile to stimulate a strong T-cell immune
response in humans as already previously seen in a variety of animal
models. These results prove the scientific concept of our adjuvant
and encourage a broad and commercial use of IC31™ in a variety of
prophylactic and therapeutic vaccines."

About tuberculosis

TB causes the death of two-three million people every year and
one-third of the world’s population is infected by the bacteria
Mycobacterium tuberculosis which makes this disease one of the most
severe global health problems. The Calmette (Bacillus
Calmette-Guérin (BCG)) vaccine is a live vaccine that, when given to
newborns, provides good protection against TB for 10-15 years.
However, when the protective effect decreases, yet another BCG
vaccination does not provide sufficient TB protection. Therefore, a
new type of TB vaccine is needed to address the need of TB protection
in the adult population.

About H1

H1 is a TB vaccine antigen in which two immuno dominant TB antigens
(Ag85B and ESAT6) are fused together by recombinant technology and
produced as a poly-protein.

About IC31TM

Adjuvants enhance the effectiveness of vaccines. Existing adjuvants
on the market induce antibodies but no or little T-cell immunity.
IC31TM is an adjuvant inducing both T-cell and B-cell responses with
a unique synthetic formulation which combines the immunostimulating
properties of an anti-microbial peptide, KLK, and an
immunostimulatory oligodeoxynucleotide, ODN1a. The two component
solution can be simply mixed with antigens, no conjugation is
required.

About Statens Serum Institut (SSI):

Statens Serum Institut (www.ssi.dk) is a public enterprise operating
as a market-oriented production and service enterprise. Statens Serum
Institut is an enterprise under the Danish Ministry of the Interior
and Health, and the Institute’s duties are partly integrated in the
national Danish health services.

Statens Serum Institut prevents and controls infectious diseases and
congenital disorders. The expertise includes:

• Monitoring, advising and teaching on the incidence, prevention and
treatment of infectious diseases and congenital disorders. •
Specializing in the diagnosis of infectious, autoimmune, congenital
and genetic diseases. • Supply of vaccines, other biological
products and diagnostic services through production and
procurement. • Preparedness against biological terrorism. •
Research and development in the Institute's areas of activity at an
international level.

The Statens Serum Institut aims to ensure advanced control of
infectious diseases, including new infections and biological threats.
The institute also strives to be a highly regarded and recognized
national and international research, production and service
enterprise.

end of announcement euro adhoc 14.03.2007 18:24:22
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market


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