euro adhoc: Intercell AG / other / Statens Serum Institut (SSI), Intercell (ICLL), and Aeras Global Tuberculosis Vaccine Foundation (Aeras) announce the initiation of a clinical trial for a novel vacc

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Disclosure announcement transmitted by euro adhoc. The issuer is responsible
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Research & Development

04.12.2007

» SSI´s novel tuberculosis subunit vaccine HyVac4-IC31 (AERAS-404)
enters phase I clinical trial in BCG-vaccinated individuals » The
vaccine is a new candidate from a group of subunit vaccines against
TB produced by SSI and aiming to boost the activity of the existing
BCG vaccine » HyVac4-IC31 (AERAS-404) is co-developed with Aeras
and formulated with Intercell´s adjuvant IC31®

December 4th, 2007 (Copenhagen, Denmark / Vienna, Austria /
Rockville, MD, USA) - SSI, ICLL, and Aeras announce that SSI´s novel
prophylactic vaccine HyVac4-IC31 (AERAS-404) against TB have entered
phase I clinical trials in BCG-vaccinated individuals. The clinical
trial has been initiated at the Karolinska Institute (Stockholm). The
new TB-vaccine HyVac4-IC31 (AERAS-404) supported by and co-developed
with AERAS is based on the H4-antigen which in the preclinical phase
has shown remarkable activity as a BCG booster.

"With the initiation of this clinical trial on the TB vaccine
molecule HyVac4 we are intensifying our efforts to provide the best
possible TB vaccine to control the global TB epidemic" says Professor
Peter Andersen, Vice President for Vaccine R&D at the SSI.

"Our proprietary adjuvant IC31® has proven to be safe and to induce a
strong and sustained immune response that has not yet been seen
before in comparable preclinical and clinical vaccine settings. We
are confident that this further vaccine candidate will fulfil the
expectations in the clinical development to target this high unmet
medical need", comments Intercell´s Chief Scientific Officer
Alexander von Gabain.

"We are pleased to be working in partnership with SSI and ICLL on
this very promising TB vaccine candidate," says Dr. Jerald C. Sadoff,
President and CEO of Aeras. "HyVac4 (AERAS-404) has induced more
significant protection in a BCG prime-boost regimen than any other
vaccine we have tested in the long-term guinea pig challenge model."

About Tuberculosis (TB):

TB causes the death of more than 1.5 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 existing Bacillus Calmette-Guérin
vaccine (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 HyVac4:

HyVac4 is a recombinantly engineered TB vaccine antigen in which
immunodominant antigens (Ag85B and TB10.4) secreted by Mycobacterium
Tuberculosis are combined to provide highly efficient and immunogenic
fusion molecules. HyVac4 is closely related to the Hybrid1 (H1) TB
vaccine antigen which earlier this year successfully completed a
phase I clinical trial in Leiden also in combination with IC31® and
for which further clinical trials are in preparation.

About IC31®:

Adjuvants enhance the effectiveness of vaccines. Existing adjuvants
on the market induce antibodies but no or little T-cell immunity.
IC31® 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. Intercell currently has IC31® collaborations with a number
of global vaccine companies, as well as small biotechs. IC31® has
also been partnered with Novartis and Wyeth for the development of a
couple of new vaccines against infectious diseases.

About Statens Serum Institut (SSI):

SSI is a public enterprise operating as a market-oriented production
and service enterprise. SSI is an enterprise under the Danish
Ministry of Health and Prevention, and the Institute´s duties are
partly integrated in the national Danish health services. SSI
prevents and controls infectious diseases, biological threats, and
congenital disorders.

About AERAS Global TB Vaccine Foundation:

Aeras Global TB Vaccine Foundation (www.aeras.org) is a non-profit
organization working as a Product Development Partnership to develop
new tuberculosis vaccines and ensure that they are affordable and
accessible to all who need them around the world.

end of announcement euro adhoc 04.12.2007 08:25:05
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-303
lmalfent@intercell.com

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


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