euro adhoc: Intercell AG / other / Intercell's Hepatitis C vaccine meets success criteria for further development - route and frequency of administration optimized (E)

--------------------------------------------------------------------------------
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.

Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

end of announcement euro adhoc 31.01.2006 17:17:03
--------------------------------------------------------------------------------

emitter: Intercell AG
Campus Vienna Biocenter 6
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
ISIN: AT0000612601
indexes:
stockmarkets: official market: Wiener Börse AG
sector: Biotechnology
language: English

OTS-ORIGINALTEXT UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS | OTB

print