euro adhoc: Intercell AG / other / Intercell´s therapeutic Hepatitis C vaccine meets primary endpoints in Phase II

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06.02.2008

» Data from 50 patients reveal statistically significant viral load
reduction and favorable safety profile
» Data confirm findings from Interim Analysis from Q3 2007
» Further clinical trials in Co-development with Novartis will
include IC31®

Vienna, Austria, February 6, 2008. Today, Intercell AG (ICLL)
announced the analysis of Phase II data for its peptide-based
therapeutic Hepatitis C vaccine (IC41) in an exploratory clinical
study targeting treatment-naïve Hepatitis C patients. The vaccine
comprises five synthetic T-cell peptides and Intercell´s
first-generation poly-arginine adjuvant (IC30). It is designed to
stimulate T-cell responses against viral protein structures conserved
throughout the major HCV genotypes, in order to reduce viral load in
the blood of chronically infected patients.

The current study comprises 50 patients chronically infected with
Genotype 1 of the Hepatitis C virus, which is known to be very
difficult to treat with Interferon/Ribavirin standard therapy. The
patients enrolled in the study have not received any other therapy
and were given 8 intradermal injections of the IC41 vaccine in
bi-weekly intervals for 14 weeks. This intensified vaccination
schedule was derived from a recent optimization study aimed at
improving the vaccine´s T-cell immune response. The desired outcome
of the ongoing study is the demonstration of a constant and sustained
decline in HCV viral load that is increased by reiterative
vaccinations during the treatment period.

"The new additional data obtained from our phase II study have
confirmed and consolidated the encouraging trend seen in our previous
interim analysis and thus, will provide a strong base to further
strengthen our HCV franchise and to accelerate our efforts towards
obtaining an HCV therapeutic vaccine, which could be a most valuable
component in a combination treatment for HCV", states Alexander von
Gabain, Chief Scientific Officer of Intercell.

In the current analysis, 50 patients have been enrolled. The data
obtained show that the primary endpoint set for this study, namely a
statistically significant sustained HCV-RNA decline, has been met. In
the second week after the final vaccination, a 40 % reduction of
viral load was observed in comparison to the baseline prior to
vaccination. The therapeutic effect of the vaccine on the viral load
is small, but found to be significant when data were submitted for
rigorous statistical analysis (p=0.0010).

The results are especially significant in the light of the
observation that viral load reduction is increasing with the number
of vaccinations. The study included patients with various levels of
viral load. In the subset of patients (N=25 with high viral load (> 2
million copies/ml) before treatment, a more pronounced average
decline of 60 % (0.4 log) was achieved with statistical significance
(p=0.0001).

Although options for the treatment of chronic Hepatitis C with
Interferon/Ribavirin have improved, treatment will remain very
difficult and a significant unmet medical need, especially in the
case of Genotype 1. Immunotherapies, and possibly therapeutic
vaccines, might become an option in the arena of existing and future
HCV combination treatments. Thus, Intercell and its co-development
partner for therapeutic Hepatitis C vaccines, Novartis, will define a
further development strategy that will also take advantage of an
enlarged antigen portfolio and of IC31®, Intercell´s
second-generation adjuvant that has recently demonstrated the
generation of T-cell responses, in human vaccine trials, to a level
not yet seen for other known adjuvants.

About Hepatitis C

HCV is a major cause of chronic liver disease, including cirrhosis
and liver cancer. According to the World Health Organization (WHO),
approximately 170 million people worldwide are chronic HCV carriers
(3% of the world´s population), including about 10 million Europeans,
3.9 million Americans and 2 million Japanese. 35,000 new infections
occur in the United States alone each year. The substantial unmet
medical need is underscored by the fact that each year 8,000 to
10,000 deaths and 1,000 liver transplants in the United States are
due to HCV. Currently, there is no vaccine against Hepatitis C and
the infection can only be treated with a combination of Interferon
and Ribavirin - a long-term therapy with limited efficacy and
substantial side effects. It also gives rise to high treatment costs
for patients. In 2002, worldwide sales of HCV drugs totalled around
EUR 2.8bn, and demand has since grown significantly. The market has
been seen to expand to about EUR 3.5bn by 2006.

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

Further inquiry note:

Contact Intercell AG:

Intercell AG

Lucia Malfent

Head of Corporate Communications

Campus Vienna Biocenter 2, A-1030 Vienna

P: +43-1-20620-303

Mail to: LMalfent@intercell.com

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