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Intercell´s therapeutic Hepatitis C vaccine meets primary endpoints in Phase II

  Disclosure announcement transmitted by euro adhoc. The issuer is responsible
  for the content of this announcement.
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

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

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