EANS-News: Intercell announces initial results of Phase II clinical trial evaluating V710, an investigational Staphylococcus aureus vaccine, in patients with end-stage renal disease

--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------

Subtitle: -
» Primary Immunogenicity and Safety objectives met
» All formulations of V710 were immunogenic following a single or two-dose
application

Vienna (Austria), November 18, 2010 (euro adhoc) - Intercell AG (VSE: ICLL)
today announced top-line results from a Phase II clinical trial of V710, an
investigational vaccine for the prevention of Staphylococcus aureus (S. aureus)
infections. The study, conducted by Intercell's collaborator, a subsidiary of
Merck & Co., Inc, (known outside the U.S. and Canada as MSD) ("Merck") was
designed to evaluate the safety and immunogenicity of V710 in patients with
end-stage renal disease (ESRD) undergoing hemodialysis treatment.

In the randomized double blind, placebo controlled study 201 patients received
vaccine or placebo at 12 centers in the U.S. The study was designed to assess
whether administration of V710 to ESRD patients receiving hemodialysis at high
risk of developing serious S. aureus infections could increase the level of
antibodies to the V710 antigen. The primary endpoints of the study were the
change of antibody levels compared to baseline at 28 days after a 2-dose regimen
provided 28 days apart and all adverse experiences for 14 days after each
vaccination. Overall the immunogenicity data suggest that V710 can elicit a
sustained immune response in a relatively immunocompromised patient population
who are at chronic risk for developing serious S. aureus infections.

Overall, the results of the safety evaluations demonstrated that V710 was
generally well tolerated when administered as a single- or multiple-dose regimen
at any dosage group studied. There were no vaccine-related serious adverse
experiences reported throughout the study duration (Days 1 to 360), and no
patients discontinued the study or subsequent vaccinations due to a
vaccine-related adverse experience.

Merck plans to present the data at an upcoming medical meeting.

"It is very encouraging to see that the S. aureus vaccine has proven immunogenic
and was generally well tolerated in ESRD patients receiving hemodialysis. We are
looking forward to the continued progress of the S. aureus program at our
strategic partner Merck", commented Gerd Zettlmeissl, CEO of Intercell.

The S. aureus vaccine candidate is based on a conserved protein antigen
discovered by Intercell and licensed to Merck 2004 on an exclusive world wide
basis. Merck is responsible for clinical development, manufacturing and
marketing. Intercell is eligible to receive milestone payments and royalties on
future net sales. In previous studies the S. aureus candidate vaccine was shown
to be immunogenic and generally well tolerated.

Further inquiry note:
Intercell AG
Lucia Malfent
Vice President, Global Head Corporate Communications
Tel. +43 1 20620-1303
[email protected]
end of announcement euro adhoc
--------------------------------------------------------------------------------

company: Intercell AG
Campus Vienna Biocenter 3
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: ATX Prime, ATX
stockmarkets: official market: Wien
language: English

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | CNE

print