Intercell Starts a Phase I Clinical Trial for a New Streptococcus pneumoniae Vaccine

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Tue Apr 7, 2009 1:53pm EDT

Intercell Starts a Phase I Clinical Trial for a New Streptococcus pneumoniae
Vaccine

- Initiation of a first-in-man Phase I clinical trial in healthy subjects

- Study aims to obtain safety and immunogenicity data of this new vaccine
candidate

- Initial results expected in Q4 2009

- Development of Intercell's Streptococcus pneumoniae vaccine supported by
PATH

VIENNA, April 7 /PRNewswire/ -- Intercell AG (VSE: ICLL) announced today that
a Phase I clinical trial with the company's vaccine candidate IC47 to prevent
disease caused by the bacterium Streptococcus pneumoniae has started.

Intercell's vaccine candidate is a recombinant subunit vaccine consisting of
three conserved surface proteins from Streptococcus pneumoniae. Two of these
proteins were discovered using Intercell's proprietary Antigen Identification
Program (AIP(R)), while the third was in-licensed from the U.S. Centers of
Disease Control and Prevention (CDC).

This Phase I trial is a first-in-man study with a focus to obtain safety and
immunogenicity data in a small population of healthy adults. Thirty-two
subjects will be enrolled in this open-label study. Two different vaccine
concentrations either with or without the addition of an adjuvant will be
tested. 

"The initiation of this clinical Phase I trial is an important step to further
strengthen Intercell's leading position in the development of vaccines against
infectious diseases with significant unmet medical need," commented
Intercell's Chief Scientific Officer, Alexander von Gabain. 

Although vaccines against Streptococcus pneumoniae are available, they cover
only a restricted number of the more than 90 known serotypes and it is
essential to pursue new vaccines for distribution in countries with the
highest medical need for an effective vaccine against the pathogen.
Intercell's novel vaccine candidate is composed of highly conserved proteins
of Streptococcus pneumoniae that have the potential to protect against all
serotypes. 

The development of Intercell's vaccine to prevent pneumococcal disease is
supported by PATH - a U.S.-based non-profit organization that creates
sustainable, culturally relevant solutions that enable communities worldwide
to break longstanding cycles of poor health. Having supported the preclinical
studies of the IC47 vaccine, PATH has now committed another USD 3.6 m for the
further clinical development until Q2 2010, including the Phase I trial. Under
the terms of the collaboration, Intercell will develop the vaccine and make it
available at an affordable cost for children in developing world countries at
greatest need, where Pneumococcus is a major cause of infant and childhood
mortality. 

About Streptococcus pneumoniae (Pneumococcus)
Streptococcus pneumoniae, or Pneumococcus, is a very common bacterial
infection in both industrialized and developing countries. In particular,
young children and the elderly represent high-risk populations of developing
pneumococcal infections. According to the WHO, the bacterium kills up to one
million children under the age of five years each year worldwide. It accounts
for many Bacterial Meningitis cases in adults and it is the most common cause
of Bacteraemia, Pneumonia, Meningitis and Otitis media in young children.

About Intercell AG
Intercell AG is an innovative biotechnology company that develops novel
vaccines for the prevention and treatment of infectious diseases with
substantial unmet medical needs. Intercell's vaccine to prevent Japanese
Encephalitis is the Company's first product on the market.

The Company's technology platforms include an antigen-discovery system,
adjuvants and a novel patch-based delivery system. Based on these
technologies, Intercell has strategic partnerships with a number of global
pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, and
Sanofi Pasteur.

The Company's pipeline includes a Travelers' Diarrhea Vaccine Patch (Phase
II), a Pseudomonas vaccine candidate (Phase II), a Vaccine Enhancement Patch
with infected Pandemic Influenza vaccines (one shot plus patch, Phase I), a
Phase II vaccine program for S. aureus, which is being developed with Merck &
Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus
(Phase I). In addition, three other products focused on infectious diseases
are in pre-clinical development.

Intercell is listed on the Vienna stock exchange under the symbol "ICLL".

For more information, please visit: www.intercell.com

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.



SOURCE  Intercell AG

Lucia Malfent, Head of Corporate Communications of Intercell AG, Campus Vienna
Biocenter 3, A-1030 Vienna, +43-1-20620-1303, LMalfent@intercell.com
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