euro adhoc: Intercell AG / other / Intercell completes Phase I clinical trial for an improved seasonal Influenza vaccine formulated with IC31® (E)

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27.02.2008

» Intercell's adjuvant IC31® demonstrates very good safety and
tolerability profile in first Phase I trial in Flu
» Seroconversion and seroprotection rates support further clinical
development
» Intercell´s strategic Flu partner Novartis to include IC31®
in further clinical trials

Vienna (Austria), February 27, 2008 - Intercell AG (VSE: ICLL) today announced
the completion of Phase I clinical trials of the company's adjuvant IC31® in
combination with the seasonal, trivalent influenza vaccine Agrippal® from
Novartis.

In this randomized, controlled Phase I trial, 72 individuals received one shot
of either Agrippal®, or Agrippal® combined with one of two different
concentrations of IC31®. All study subjects were healthy, adult volunteers, with
an average age of approximately 31 years. The majority of participants had
pre-existing immune responses against influenza strains prior to the trial.
Subjects were followed for general safety and local tolerability. Vaccine
specific immune responses were analyzed 10 and 21 days after the vaccination.
The study was conducted at Vienna Medical University, Department of Clinical
Pharmacology.

The IC31® adjuvanted vaccine showed - even in the highest IC31® dose group - an
excellent safety and tolerability profile, which was comparable to the
non-adjuvanted standard vaccine.Furthermore in all study groups vaccination with
the test vaccine led to the induction of virus specific T-cells and protective
levels of antibody responses against the three included influenza strains.

"We are excited about the excellent safety and tolerability profile of our IC31®
in combination with seasonal influenza antigens in humans", states Gerd
Zettlmeissl, Chief Executive Officer of Intercell. "This result in combination
with the outstanding immunogenicity data in immuno-compromised animals has paved
the way towards the development of improved Flu vaccines."

IC31® has potential as adjuvant for improved influenza vaccines. Novartis will
include IC31® in its further clinical development program.

More influenza vaccines are needed with superior immune-response and excellent
cross-protection against drifted influenza viruses in the elderly, the age group
with the greatest number of death from the annual influenza outbreaks.

As part of the agreement between Novartis and Intercell, signed in July 2007,
Novartis has an exclusive license for development of Intercell´s IC31® adjuvant
in novel influenza vaccines with milestones for Intercell of up to approximately
EUR 100 m during the development period and double-digit royalty rates tied to
sales performance.

About IC31®

Vaccines, based on antigens alone, are not sufficient to provide full
protection. Adjuvants are needed to educate the immune system to recognize and
eliminate the pathogens efficiently.
IC31® is an adjuvant that induces T-cell and B-cell responses by using a unique
synthetic formulation which combines the immunostimulating properties of an
anti-microbial peptide, KLK, and an immunostimulatory oligodeoxynucleotide,
ODN1a. The two component solution can be simply mixed with antigens; no
conjugation is required.
Intercell currently uses IC31® in collaborations with a number of global vaccine
companies and biotech companies. These collaborations include amongst others the
development of a tuberculosis vaccine in Phase I clinical trials, which has been
partnered with the Danish Statens Serum Institut and Sanofi Pasteur.

About Influenza

The flu is a contagious respiratory illness caused by influenza viruses. The
infection usually lasts for about a week. It is characterized by sudden onset of
high fever, myalgia, headache and severe malaise, non-productive cough, sore
throat, and rhinitis. From 1918 to 1919, the "Spanish Flu" killed more people in
the world-wide pandemic than did the First World War.
Influenza viruses cause disease among all age groups. Rates of infection are
highest among children, but rates of serious illness and death are highest among
persons aged >65 years and children aged <2 years. Influenza rapidly spreads
around the world in seasonal epidemics and imposes a considerable economic
burden in the form of hospital and other health care costs and lost
productivity.

In annual influenza epidemics 5-15% of the population are affected with upper
respiratory tract infections. Hospitalization and deaths mainly occur in
high-risk groups. Although difficult to assess, these annual epidemics are
thought to result in between three and five million cases of severe illness and
between 250 000 and 500 000 deaths every year around the world.
Vaccination is the principal measure for preventing influenza and reducing the
impact of epidemics. The currently available, mostly not adjuvanted vaccine
products have a suboptimal efficacy profile, especially in the population groups
with the highest disease burden (elderly and infants). Furthermore, these
vaccines only offer limited cross-protection against other influenza strains,
with no or low T-cell responses. Due to these limitations, novel vaccines with
improved efficacy and T-cell immunity are needed.

About Novartis´ adjuvanted Influenza vaccine programs

Novartis currently is the only vaccine manufacturer offering an adjuvanted
seasonal influenza vaccine, with more than 30 million doses administered over
the past 10 years. FLUAD, when compared to currently available influenza
vaccines, induced a higher level of immune response, superior clinical
effectiveness and protection against a broader range of influenza strains in
vulnerable populations, at higher risk of post-influenza complications.

Further inquiry note:
Lucia Malfent
Head of Corporate Communications
Campus Vienna Biocenter 2, A-1030 Vienna
P: +43-1-20620-303
Mail to: [email protected]

end of announcement euro adhoc
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emitter: Intercell AG
Campus Vienna Biocenter 6
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: [email protected]
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes:
stockmarkets: official market: Wiener Börse AG
language: English

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