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Intercell's Hepatitis C vaccine meets success criteria for further development - route and frequency of administration optimized

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
31.01.2006
Intercell (VSE; "ICLL") today announced initial data from a clinical
trial aiming at the optimization of its therapeutic Hepatitis C
vaccine IC41. Results indicate that IC41, given in optimized route
and schedule, is considerably more immunogenic than it has been shown
previously.
These results will make it possible for Intercell to expand its
leading position in Hepatitis C therapeutic vaccination through a
clearly structured development plan that will include additional
trials in Hepatitis C patients. In the current trial, 50 healthy
adults were vaccinated with IC41 in alternative regimes. In order to
increase T-cell response, which plays an essential role in the
natural defense against the Hepatitis C virus, various intervals,
numbers and routes of vaccination were tested. In an IC41 Phase II
trial that has already been completed, the strongest T-cell responses
were associated with a clinically meaningful decline of HCV-RNA.
The optimization study shows that the T-cell responses were stronger
and significantly more frequent than seen up to now. This was true
for both CD4- and CD8- positive T-cells. Compared to the previous
regime, the improvements were positive and meet the success criteria
for further development. The favourable safety profile and local
tolerability seen in previous trials involving approximately 300
healthy volunteers and Hepatitis C-patients was maintained. The final
results of the study will be presented at the European Association
for the Study of the Liver (EASL) congress April 26-30, 2006, in
Vienna.
Based on these results, Intercell is now planning to test IC41 with
this optimized schedule in a further Phase II trial in patients with
chronic Hepatitis C. This study aims to show sustained reductions of
HCV-RNA through IC41 stand-alone therapy in a substantial subset of
patients. Intercell plans to start the trial in mid-2006, with first
results expected in mid-2007. The estimated date for market launch is
currently 2011.
Furthermore, results from an ongoing Phase II study in combination
with Interferon/Ribavirin standard therapy are expected for mid-2006.
The primary objectives of this study are safety and the
pharmacodynamic interactions of IC41 with standard therapy. Intercell
hopes the study will further support the development of IC41 in a
combination therapy setting using the new and improved administration
scheme of IC41.
"The significant improvement in critical T-cell responses in
connection with the new optimized schedule and the viral load
reductions that were observed in previous clinical trials with
chronic Hepatitis C patients give encouraging support towards a
further clinical Phase II trial to demonstrate the therapeutic effect
of IC41", states Prof. Michael P. Manns from Hanover Medical School,
key investigator in Intercell’s past and upcoming patient trials.
"We are following a very straightforward development strategy. The
results of the optimization trial are encouraging and confirm our
scientific and clinical approach in the development of a therapeutic
Hepatitis C vaccine to meet a substantial medical need", 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),
worldwide, approximately 170 million people 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 transplantations in the United States
are due to HCV.
Currently, there is no vaccine or immunotherapy 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 totaled at
around EUR2.8bn, and demand has since grown significantly. The market
is seen to be expanding to EUR3.5bn by 2006.
This communication expressly or implicitly contains certain
forward-looking statements concerning Intercell AG and its business.
Such statements involve certain known and unknown risks,
uncertainties and other factors which could cause the actual results,
financial condition, performance or achievements of Intercell AG to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Intercell AG is providing this communication as of this date and does
not undertake to update any forward-looking statements contained
herein as a result of new information, future events or otherwise.
end of announcement                               euro adhoc 31.01.2006 17:17:03

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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