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

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Research & Development

20.08.2007

»First data from 25 patients reveals statistically significant viral
load reduction and very good safety profile

»Data opens door for therapeutic vaccination in the arena of existing
and future treatment options - but not yet a breakthrough for
vaccination as monotherapy

»Data still has to be interpreted with caution given the small sample
size - full study data expected for Q1 2008

Vienna, Austria, 20 August 2007. Today, Intercell AG (ICLL) announced
the analysis of Phase II interim data for its peptide-based
therapeutic Hepatitis C vaccine (IC41) in an exploratory clinical
study targeting treatment-naïve Hepatitis C patients. The vaccine
comprises eight T-cell antigens 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.

In the current interim analysis, 25 patients have been evaluated in
the "per protocol" population. The data obtained shows 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 (0.2
log) 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 was submitted for rigorous
statistical analysis (p=0.0178).

The results are especially significant in the light of the
observation that viral load reduction is increasing with the number
of vaccinations and is most pronounced two weeks after the
vaccination schedule has been concluded. The study included patients
with various levels of viral loads. In the subset of patients (N=12)
with high viral load (> 2 million copies/ml) before treatment, a
statistically significant (p=0.0168) average decline of 60 % (0.4
log) was achieved. Thus, it seems that the therapeutic effect is more
pronounced when the patients´ immune system is unable to keep the
viral load in check.

Final results of the study with the full set of patients and an
analysis of HCV-RNA and T-cell responses until 24 weeks after the
last vaccination are expected in early 2008. Furthermore, an extended
analysis of how the therapeutic effect relates to the induction of
T-cell responses has to be awaited until the final outcome of the
trial.

Although the interim analysis is restricted by the limited number of
subjects evaluated at this stage, the present findings - if confirmed
by the final data - would indicate for the first time that a
therapeutic vaccination schedule is able to reduce HCV viral load and
has thereby potentially opened a new door for HCV treatment.

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 might 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.

"The new data obtained encourages us very much to further strengthen
our HCV franchise and to accelerate our efforts towards obtaining an
HCV therapeutic vaccine", states Gerd Zettlmeissl, CEO of Intercell.

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 20.08.2007 17:04:21
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:
Contact Intercell AG:
Gerd Zettlmeissl, CEO
Campus Vienna Biocenter 2, A-1030 Vienna
P: +43-1-20620-121
Mail to: gzettlmeissl@intercell.com

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